Trial Outcomes & Findings for Improving Attentional and Cognitive Control in the Psychological Treatment of Intrusive Thoughts (NCT NCT04225624)
NCT ID: NCT04225624
Last Updated: 2026-03-10
Results Overview
15-item self-report measure of transdiagnostic repetitive negative thinking that includes items about thoughts as repetitive, intrusive, unproductive, and capturing mental capacity (e.g., "I think about many problems without solving any of them"). Total scores range from 0-60, with higher scores indicating more repetitive negative thinking (i.e., worse outcomes).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Results posted on
2026-03-10
Participant Flow
Phase I: 3 pilot participants were eligible and enrolled. Phase 2: 62 were eligible and randomized.
Participant milestones
| Measure |
Phase 1: Pilot Testing Phase
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Phase 2 (RCT): Treatment Period
STARTED
|
0
|
31
|
31
|
|
Phase 2 (RCT): Treatment Period
COMPLETED
|
0
|
25
|
28
|
|
Phase 2 (RCT): Treatment Period
NOT COMPLETED
|
0
|
6
|
3
|
|
Phase 2 (RCT): 3-month Follow-up
STARTED
|
0
|
25
|
28
|
|
Phase 2 (RCT): 3-month Follow-up
COMPLETED
|
0
|
23
|
28
|
|
Phase 2 (RCT): 3-month Follow-up
NOT COMPLETED
|
0
|
2
|
0
|
|
Phase 1: Pilot Testing
STARTED
|
3
|
0
|
0
|
|
Phase 1: Pilot Testing
COMPLETED
|
3
|
0
|
0
|
|
Phase 1: Pilot Testing
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: Pilot Testing Phase
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Phase 2 (RCT): Treatment Period
Physician Decision
|
0
|
2
|
0
|
|
Phase 2 (RCT): Treatment Period
Withdrawal by Subject
|
0
|
4
|
3
|
|
Phase 2 (RCT): 3-month Follow-up
Physician Decision
|
0
|
1
|
0
|
|
Phase 2 (RCT): 3-month Follow-up
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Improving Attentional and Cognitive Control in the Psychological Treatment of Intrusive Thoughts
Baseline characteristics by cohort
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.00 Year
STANDARD_DEVIATION 17.69 • n=68 Participants
|
32.24 Year
STANDARD_DEVIATION 9.37 • n=69 Participants
|
31.07 Year
STANDARD_DEVIATION 9.10 • n=137 Participants
|
31.66 Year
STANDARD_DEVIATION 9.18 • n=88 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=68 Participants
|
24 Participants
n=69 Participants
|
21 Participants
n=137 Participants
|
46 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=68 Participants
|
7 Participants
n=69 Participants
|
10 Participants
n=137 Participants
|
19 Participants
n=88 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
4 Participants
n=69 Participants
|
6 Participants
n=137 Participants
|
10 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
4 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
5 Participants
n=88 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=68 Participants
|
22 Participants
n=69 Participants
|
17 Participants
n=137 Participants
|
42 Participants
n=88 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
3 Participants
n=88 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
5 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=68 Participants
|
6 Participants
n=69 Participants
|
6 Participants
n=137 Participants
|
12 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=68 Participants
|
25 Participants
n=69 Participants
|
25 Participants
n=137 Participants
|
53 Participants
n=88 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=68 Participants
|
31 Participants
n=69 Participants
|
31 Participants
n=137 Participants
|
65 Participants
n=88 Participants
|
|
Education
High school graduate or less
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
5 Participants
n=137 Participants
|
5 Participants
n=88 Participants
|
|
Education
Some college
|
0 Participants
n=68 Participants
|
5 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
8 Participants
n=88 Participants
|
|
Education
College graduate
|
3 Participants
n=68 Participants
|
10 Participants
n=69 Participants
|
6 Participants
n=137 Participants
|
19 Participants
n=88 Participants
|
|
Education
Graduate or professional school
|
0 Participants
n=68 Participants
|
16 Participants
n=69 Participants
|
17 Participants
n=137 Participants
|
33 Participants
n=88 Participants
|
PRIMARY outcome
Timeframe: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)Population: Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 4), end-of-treatment (week 8), or 3-month follow-up (week 20) assessments (see participant flow chart). Finally, a few more did not complete this self-rated questionnaire despite completing other measures at the same timepoint.
15-item self-report measure of transdiagnostic repetitive negative thinking that includes items about thoughts as repetitive, intrusive, unproductive, and capturing mental capacity (e.g., "I think about many problems without solving any of them"). Total scores range from 0-60, with higher scores indicating more repetitive negative thinking (i.e., worse outcomes).
Outcome measures
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Transdiagnostic Repetitive Negative Thinking (Measured by the Perseverative Thinking Questionnaire [PTQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 0
|
45.67 score on a scale (by group)
Standard Deviation 5.86
|
45.29 score on a scale (by group)
Standard Deviation 5.69
|
45.94 score on a scale (by group)
Standard Deviation 5.76
|
|
Transdiagnostic Repetitive Negative Thinking (Measured by the Perseverative Thinking Questionnaire [PTQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 4
|
31.33 score on a scale (by group)
Standard Deviation 15.04
|
34.85 score on a scale (by group)
Standard Deviation 11.33
|
36.64 score on a scale (by group)
Standard Deviation 8.61
|
|
Transdiagnostic Repetitive Negative Thinking (Measured by the Perseverative Thinking Questionnaire [PTQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 8
|
27.00 score on a scale (by group)
Standard Deviation 5.29
|
25.88 score on a scale (by group)
Standard Deviation 10.33
|
31.96 score on a scale (by group)
Standard Deviation 11.96
|
|
Transdiagnostic Repetitive Negative Thinking (Measured by the Perseverative Thinking Questionnaire [PTQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 20
|
—
|
29.43 score on a scale (by group)
Standard Deviation 11.71
|
31.52 score on a scale (by group)
Standard Deviation 12.96
|
SECONDARY outcome
Timeframe: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)Population: Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 4), end-of-treatment (week 8), or 3-month follow-up (week 20) assessments (see participant flow chart). Finally, a few more did not complete this self-rated questionnaire despite completing other measures at the same timepoint.
16-item self-report measure of the tendency to engage in excessive, uncontrollable, and generalized worry (e.g., "I am always worrying about something"). Total scores range from 16-80, with higher scores indicating more worry (i.e., worse outcomes).
Outcome measures
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Worry (Measured by the Penn State Worry Questionnaire [PSWQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 0
|
62.33 score on a scale (by group)
Standard Deviation 10.50
|
67.83 score on a scale (by group)
Standard Deviation 11.65
|
67.17 score on a scale (by group)
Standard Deviation 9.96
|
|
Worry (Measured by the Penn State Worry Questionnaire [PSWQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 4
|
58.00 score on a scale (by group)
Standard Deviation 13.23
|
63.35 score on a scale (by group)
Standard Deviation 10.83
|
63.81 score on a scale (by group)
Standard Deviation 8.75
|
|
Worry (Measured by the Penn State Worry Questionnaire [PSWQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 8
|
51.33 score on a scale (by group)
Standard Deviation 12.66
|
58.16 score on a scale (by group)
Standard Deviation 11.85
|
61.18 score on a scale (by group)
Standard Deviation 10.63
|
|
Worry (Measured by the Penn State Worry Questionnaire [PSWQ]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 20
|
—
|
60.00 score on a scale (by group)
Standard Deviation 12.10
|
60.26 score on a scale (by group)
Standard Deviation 11.35
|
SECONDARY outcome
Timeframe: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)Population: Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 4), end-of-treatment (week 8), or 3-month follow-up (week 20) assessments (see participant flow chart). Finally, a few more did not complete this self-rated questionnaire despite completing other measures at the same timepoint.
22-item self-report measure of the tendency to ruminate or dwell on one's distress and it's possible causes and consequences when feeling down, sad, or depressed (e.g., "Think about all your shortcomings, failings, faults, mistakes"). Total scores range from 22-88, with higher scores indicating more rumination (i.e., worse outcomes).
Outcome measures
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Rumination (Measured by the Rumination Response Scale [RRS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 20
|
—
|
51.81 score on a scale (by group)
Standard Deviation 12.87
|
51.48 score on a scale (by group)
Standard Deviation 13.08
|
|
Rumination (Measured by the Rumination Response Scale [RRS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 0
|
58.33 score on a scale (by group)
Standard Deviation 7.23
|
60.63 score on a scale (by group)
Standard Deviation 10.73
|
61.55 score on a scale (by group)
Standard Deviation 11.31
|
|
Rumination (Measured by the Rumination Response Scale [RRS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 4
|
54.67 score on a scale (by group)
Standard Deviation 7.51
|
54.54 score on a scale (by group)
Standard Deviation 13.89
|
54.19 score on a scale (by group)
Standard Deviation 12.64
|
|
Rumination (Measured by the Rumination Response Scale [RRS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 8
|
53.67 score on a scale (by group)
Standard Deviation 9.07
|
49.20 score on a scale (by group)
Standard Deviation 12.81
|
49.96 score on a scale (by group)
Standard Deviation 12.23
|
SECONDARY outcome
Timeframe: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)Population: Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 4), end-of-treatment (week 8), or 3-month follow-up (week 20) assessments (see participant flow chart). Finally, a few more did not complete this self-rated questionnaire despite completing other measures at the same timepoint.
The ROCS is a 33-item self-report measure that assesses the frequency of various mental responses to obsessional thoughts or images in the past month with 3 sub-scales: Mental Neutralizing, Acceptance, and Rumination on OCD symptoms (no total score is used). The Mental Neutralizing Sub-Scale is 18 items and specifically assesses mental rituals including arguing with oneself, reconstructing rituals, effort against thoughts, and distraction (e.g., "I feel compelled to collect all arguments that refute the intrusive thought or image"). Total scores (which are an average of the subscale items) range from 0-4, with higher scores indicating more mental rituals (i.e., worse outcomes).
Outcome measures
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Mental Rituals (Measured by the Rumination on Obsessions and Compulsions Scale [ROCS] - Mental Neutralizing Subscale) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 0
|
2.65 score on a scale (by group)
Standard Deviation 0.08
|
2.05 score on a scale (by group)
Standard Deviation 0.53
|
1.97 score on a scale (by group)
Standard Deviation 0.75
|
|
Mental Rituals (Measured by the Rumination on Obsessions and Compulsions Scale [ROCS] - Mental Neutralizing Subscale) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 4
|
2.04 score on a scale (by group)
Standard Deviation 0.45
|
1.76 score on a scale (by group)
Standard Deviation 0.53
|
1.88 score on a scale (by group)
Standard Deviation 0.66
|
|
Mental Rituals (Measured by the Rumination on Obsessions and Compulsions Scale [ROCS] - Mental Neutralizing Subscale) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 8
|
1.50 score on a scale (by group)
Standard Deviation 0.43
|
1.56 score on a scale (by group)
Standard Deviation 0.47
|
1.74 score on a scale (by group)
Standard Deviation 0.76
|
|
Mental Rituals (Measured by the Rumination on Obsessions and Compulsions Scale [ROCS] - Mental Neutralizing Subscale) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 20
|
—
|
1.58 score on a scale (by group)
Standard Deviation 0.47
|
1.56 score on a scale (by group)
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)Population: Only participants who had symptoms of OCD completed the Y-BOCS (n=35 out of 62). Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 4), end-of-treatment (week 8), or 3-month follow-up (week 20) assessments (see participant flow chart).
10-item clinician-administered interview measure of past week symptom severity of obsessions and compulsions including: time, interference, distress, resistance, and control. Total scores range from 0-40, with higher scores indicating higher levels of OCD symptom severity (i.e., worse outcomes).
Outcome measures
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=16 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=19 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
OCD Symptom Severity (Measured by the Yale-Brown Obsessive-Compulsive Scale [Y-BOCS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 0
|
20.33 score on a scale (by group)
Standard Deviation 5.13
|
23.81 score on a scale (by group)
Standard Deviation 3.76
|
22.84 score on a scale (by group)
Standard Deviation 5.92
|
|
OCD Symptom Severity (Measured by the Yale-Brown Obsessive-Compulsive Scale [Y-BOCS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 4
|
18.67 score on a scale (by group)
Standard Deviation 4.93
|
21.42 score on a scale (by group)
Standard Deviation 1.83
|
19.25 score on a scale (by group)
Standard Deviation 3.91
|
|
OCD Symptom Severity (Measured by the Yale-Brown Obsessive-Compulsive Scale [Y-BOCS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 8
|
17.00 score on a scale (by group)
Standard Deviation 3.61
|
15.92 score on a scale (by group)
Standard Deviation 4.62
|
17.69 score on a scale (by group)
Standard Deviation 6.42
|
|
OCD Symptom Severity (Measured by the Yale-Brown Obsessive-Compulsive Scale [Y-BOCS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 20
|
—
|
18.33 score on a scale (by group)
Standard Deviation 5.99
|
17.94 score on a scale (by group)
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)Population: Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 4), end-of-treatment (week 8), or 3-month follow-up (week 20) assessments (see participant flow chart). Finally, one participant dropped out of the study after completing week 4 self-rated questionnaires and before completing this clinician-rated measure.
14-item structured, clinician-administered interview measure of past week anxiety symptom severity including: anxious mood, tension, fears, insomnia, cognitive symptoms, depressed mood, somatic (muscular, sensory) symptoms, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and observed behavior. Total scores range from 0-56, with higher scores indicating higher levels of generalized anxiety symptoms (i.e., worse outcomes).
Outcome measures
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Generalized Anxiety Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale [SIGH-A]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 0
|
20.67 score on a scale (by group)
Standard Deviation 14.36
|
22.84 score on a scale (by group)
Standard Deviation 5.53
|
22.71 score on a scale (by group)
Standard Deviation 6.91
|
|
Generalized Anxiety Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale [SIGH-A]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 4
|
17.00 score on a scale (by group)
Standard Deviation 9.54
|
18.00 score on a scale (by group)
Standard Deviation 6.63
|
15.86 score on a scale (by group)
Standard Deviation 5.94
|
|
Generalized Anxiety Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale [SIGH-A]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 8
|
18.67 score on a scale (by group)
Standard Deviation 14.47
|
13.60 score on a scale (by group)
Standard Deviation 6.56
|
14.29 score on a scale (by group)
Standard Deviation 7.51
|
|
Generalized Anxiety Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Anxiety Rating Scale [SIGH-A]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 20
|
—
|
15.17 score on a scale (by group)
Standard Deviation 5.58
|
12.93 score on a scale (by group)
Standard Deviation 5.86
|
SECONDARY outcome
Timeframe: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)Population: Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 4), end-of-treatment (week 8), or 3-month follow-up (week 20) assessments (see participant flow chart). Finally, one participant dropped out of the study after completing week 4 self-rated questionnaires and before completing this clinician-rated measure.
17-item interview measure of past week depression symptom severity including: depressed mood, interest in work and activities, insomnia (early, middle, and late), genital symptoms, gastrointestinal somatic symptoms, loss of weight, general somatic symptoms, feelings of guilt, suicide, psychic anxiety, somatic anxiety, hypochondriasis, insight, agitation, retardation. Total scores range from 0-52, with higher scores indicating more depression (i.e., worse outcomes).
Outcome measures
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Depression Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Depression Rating Scale [SIGH-D]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 0
|
14.33 score on a scale (by group)
Standard Deviation 8.50
|
18.61 score on a scale (by group)
Standard Deviation 4.44
|
18.48 score on a scale (by group)
Standard Deviation 5.30
|
|
Depression Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Depression Rating Scale [SIGH-D]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 4
|
13.33 score on a scale (by group)
Standard Deviation 8.50
|
15.15 score on a scale (by group)
Standard Deviation 5.09
|
13.39 score on a scale (by group)
Standard Deviation 5.49
|
|
Depression Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Depression Rating Scale [SIGH-D]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 8
|
13.67 score on a scale (by group)
Standard Deviation 11.37
|
10.96 score on a scale (by group)
Standard Deviation 5.68
|
11.93 score on a scale (by group)
Standard Deviation 5.50
|
|
Depression Symptom Severity (Measured by the Structured Interview Guide for the Hamilton Depression Rating Scale [SIGH-D]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 20
|
—
|
12.30 score on a scale (by group)
Standard Deviation 4.89
|
11.54 score on a scale (by group)
Standard Deviation 5.36
|
SECONDARY outcome
Timeframe: Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)Population: Intent-to-treat analysis, which included all participants randomized to each treatment arm. Some participants dropped out prior to completion of the mid-treatment (week 4), end-of-treatment (week 8), or 3-month follow-up (week 20) assessments (see participant flow chart). Finally, a few more did not complete this self-rated questionnaire despite completing other measures at the same timepoint.
5-item self-report scale assessing disability in work, home management, social leisure activities, private leisure activities, and the ability to form and maintain close relationships. Total scores range from 0-40, with higher scores indicating more functional impairment (i.e., worse outcomes).
Outcome measures
| Measure |
Phase 1: Pilot Testing Phase
n=3 Participants
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 Participants
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Functional Impairment (Measured by the Work and Social Adjustment Scale [WSAS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 0
|
22.67 score on a scale (by group)
Standard Deviation 8.02
|
24.68 score on a scale (by group)
Standard Deviation 5.49
|
24.45 score on a scale (by group)
Standard Deviation 6.46
|
|
Functional Impairment (Measured by the Work and Social Adjustment Scale [WSAS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 4
|
16.33 score on a scale (by group)
Standard Deviation 12.58
|
15.77 score on a scale (by group)
Standard Deviation 7.91
|
17.33 score on a scale (by group)
Standard Deviation 7.70
|
|
Functional Impairment (Measured by the Work and Social Adjustment Scale [WSAS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 8
|
11.33 score on a scale (by group)
Standard Deviation 8.14
|
13.16 score on a scale (by group)
Standard Deviation 8.26
|
16.00 score on a scale (by group)
Standard Deviation 8.78
|
|
Functional Impairment (Measured by the Work and Social Adjustment Scale [WSAS]) Assessed in Phase I (Pilot Trial) and Group Differences Compared at 8 Weeks in Phase 2 Randomized Controlled Trial
Week 20
|
—
|
11.71 score on a scale (by group)
Standard Deviation 8.04
|
11.81 score on a scale (by group)
Standard Deviation 8.40
|
Adverse Events
Phase 1: Pilot Testing Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase 2: Supportive Psychotherapy (SPT)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: Pilot Testing Phase
n=3 participants at risk
Individuals with repetitive negative thinking receiving Emotion Regulation Therapy - Attention Regulation
|
Phase 2: Emotion Regulation Therapy - Attention Regulation (AR-ERT)
n=31 participants at risk
Individuals with repetitive negative thinking randomized to Emotion Regulation Therapy - Attention Regulation.
|
Phase 2: Supportive Psychotherapy (SPT)
n=31 participants at risk
Individuals with repetitive negative thinking randomized to Supportive Psychotherapy.
|
|---|---|---|---|
|
Immune system disorders
Allergies
|
0.00%
0/3 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
6.5%
2/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
0.00%
0/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
|
Infections and infestations
Cold/Flu/COVID
|
0.00%
0/3 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
19.4%
6/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
19.4%
6/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
|
General disorders
EEG discomfort
|
0.00%
0/3 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
9.7%
3/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
6.5%
2/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
|
Musculoskeletal and connective tissue disorders
Hip, neck, back, foot/ankle injury or stiffness or tendonitis
|
0.00%
0/3 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
12.9%
4/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
12.9%
4/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
|
Psychiatric disorders
Increased depression/anxiety/stress
|
0.00%
0/3 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
16.1%
5/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
6.5%
2/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
9.7%
3/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
3.2%
1/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
|
Infections and infestations
Yeast infection / UTI
|
0.00%
0/3 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
3.2%
1/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
6.5%
2/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
|
Renal and urinary disorders
Kidney failure
|
33.3%
1/3 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
0.00%
0/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
0.00%
0/31 • Week 0 (baseline), week 4 (mid-treatment), week 8 (post-treatment), and week 20 (3-month follow-up)
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in further inquiries into specific adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place