Trial Outcomes & Findings for Transdiagnostic Brain-Behavior Profiling to Enhance Cognitive Behavioral Therapy Response (NCT NCT03175068)
NCT ID: NCT03175068
Last Updated: 2026-06-23
Results Overview
Patients were randomized to either 12 weeks of cognitive behavioral therapy or supportive therapy. Healthy control (HC) participants did not receive treatment but completed the same assessments at the same time points as patients. Liebowitz Social Anxiety Scale (LSAS) and Hamilton Depression Rating Scale (HDRS) served as primary outcome measures as they are interviewer based standard clinical measures. A composite score combining LSAS and HDRS was constructed using proportion of maximum scaling (POMS) method to represent symptom severity. Higher scores mean worse outcomes. The minimum value is 0 and the maximum value is 1.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
203 participants
Primary outcome timeframe
baseline and week 12
Results posted on
2026-06-23
Participant Flow
35 participants consented to the study (included in protocol enrollment) but were not randomized due to study ineligibility or early withdrawal from the study.
Participant milestones
| Measure |
Cognitive Behavioral Therapy (CBT)
The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.
CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
|
Supportive Therapy (ST)
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance
|
Control
Over a 12-week period, the control group will not receive treatment. Controls will do complete EEG, MRI, and Neuropsychological assessments.
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
57
|
50
|
|
Overall Study
COMPLETED
|
51
|
43
|
31
|
|
Overall Study
NOT COMPLETED
|
10
|
14
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 CBT participant did not report their sex/gender identity so they are not included in the count.
Baseline characteristics by cohort
| Measure |
Control
n=50 Participants
Over a 12-week period, the control group will not receive treatment. Controls will do complete EEG, MRI, and Neuropsychological assessments.
|
Supportive Therapy (ST)
n=57 Participants
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
|
Cognitive Behavioral Therapy (CBT)
n=61 Participants
The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.
CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=50 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=168 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=50 Participants
|
57 Participants
n=57 Participants
|
61 Participants
n=61 Participants
|
168 Participants
n=168 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=168 Participants
|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 10.7 • n=50 Participants
|
27.3 years
STANDARD_DEVIATION 9.5 • n=57 Participants
|
28.0 years
STANDARD_DEVIATION 8.7 • n=61 Participants
|
28.7 years
STANDARD_DEVIATION 9.7 • n=168 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=50 Participants • 1 CBT participant did not report their sex/gender identity so they are not included in the count.
|
37 Participants
n=57 Participants • 1 CBT participant did not report their sex/gender identity so they are not included in the count.
|
42 Participants
n=60 Participants • 1 CBT participant did not report their sex/gender identity so they are not included in the count.
|
108 Participants
n=167 Participants • 1 CBT participant did not report their sex/gender identity so they are not included in the count.
|
|
Sex: Female, Male
Male
|
21 Participants
n=50 Participants • 1 CBT participant did not report their sex/gender identity so they are not included in the count.
|
20 Participants
n=57 Participants • 1 CBT participant did not report their sex/gender identity so they are not included in the count.
|
18 Participants
n=60 Participants • 1 CBT participant did not report their sex/gender identity so they are not included in the count.
|
59 Participants
n=167 Participants • 1 CBT participant did not report their sex/gender identity so they are not included in the count.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=50 Participants
|
20 Participants
n=57 Participants
|
14 Participants
n=61 Participants
|
42 Participants
n=168 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=50 Participants
|
37 Participants
n=57 Participants
|
47 Participants
n=61 Participants
|
126 Participants
n=168 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
1 Participants
n=57 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=50 Participants
|
11 Participants
n=57 Participants
|
13 Participants
n=61 Participants
|
42 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=50 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=61 Participants
|
1 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=50 Participants
|
10 Participants
n=57 Participants
|
5 Participants
n=61 Participants
|
20 Participants
n=168 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=50 Participants
|
23 Participants
n=57 Participants
|
31 Participants
n=61 Participants
|
78 Participants
n=168 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=50 Participants
|
4 Participants
n=57 Participants
|
3 Participants
n=61 Participants
|
8 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=50 Participants
|
8 Participants
n=57 Participants
|
9 Participants
n=61 Participants
|
18 Participants
n=168 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
57 participants
n=57 Participants
|
61 participants
n=61 Participants
|
168 participants
n=168 Participants
|
|
Principal Diagnoses
MDD Primary Diagnosis
|
0 Participants
Only counting participant in the treatment receiving arms (ST and CBT)
|
26 Participants
n=57 Participants • Only counting participant in the treatment receiving arms (ST and CBT)
|
32 Participants
n=61 Participants • Only counting participant in the treatment receiving arms (ST and CBT)
|
58 Participants
n=118 Participants • Only counting participant in the treatment receiving arms (ST and CBT)
|
|
Principal Diagnoses
SAD Primary Diagnosis
|
0 Participants
Only counting participant in the treatment receiving arms (ST and CBT)
|
31 Participants
n=57 Participants • Only counting participant in the treatment receiving arms (ST and CBT)
|
29 Participants
n=61 Participants • Only counting participant in the treatment receiving arms (ST and CBT)
|
60 Participants
n=118 Participants • Only counting participant in the treatment receiving arms (ST and CBT)
|
PRIMARY outcome
Timeframe: baseline and week 12Population: Only participants who completed the entire study (with data at baseline and week 12) were included.
Patients were randomized to either 12 weeks of cognitive behavioral therapy or supportive therapy. Healthy control (HC) participants did not receive treatment but completed the same assessments at the same time points as patients. Liebowitz Social Anxiety Scale (LSAS) and Hamilton Depression Rating Scale (HDRS) served as primary outcome measures as they are interviewer based standard clinical measures. A composite score combining LSAS and HDRS was constructed using proportion of maximum scaling (POMS) method to represent symptom severity. Higher scores mean worse outcomes. The minimum value is 0 and the maximum value is 1.
Outcome measures
| Measure |
Control
n=29 Participants
Healthy control participants did not receive treatment.
|
Cognitive Behavioral Therapy
n=51 Participants
The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.
CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
|
Supportive Therapy
n=44 Participants
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period, sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance
|
|---|---|---|---|
|
Changes in Symptom Severity From Baseline to Week 12 Between Treatment Arms
baseline
|
.05 units on a scale
Standard Deviation .06
|
0.884 units on a scale
Standard Deviation 0.254
|
0.869 units on a scale
Standard Deviation 0.261
|
|
Changes in Symptom Severity From Baseline to Week 12 Between Treatment Arms
week 12
|
.04 units on a scale
Standard Deviation .05
|
0.482 units on a scale
Standard Deviation 0.299
|
0.601 units on a scale
Standard Deviation 0.321
|
PRIMARY outcome
Timeframe: baselinePopulation: Primary outcomes did not include hypotheses related to differences between treatment arms (cognitive behavioral therapy, supportive therapy); therefore, analyses were collapsed across treatment arms.
Outcomes are parameter estimates (arbitrary units) of brain activity for a priori brain regions of interest (bilateral amygdala, bilateral dorsolateral prefrontal cortex ('DLPFC'), bilateral inferior frontal gyrus ('IFG')) comparing brain activity during task conditions against a baseline condition (look at neutral images; 'Look Neut'). Task conditions are reappraising negative images ('Reappraise') and looking at negative images ('Look Neg'). The Reappraise vs. Look Neut and Look Neg vs. Look Neut are the contrasts of interest. Not all participants who consented to the study completed this task at all time points. Reasons include dropping out of the study, COVID shutdowns, scheduling issues, and participants not consenting to perform task due to use of negative images. Higher values represent greater activation.
Outcome measures
| Measure |
Control
n=38 Participants
Healthy control participants did not receive treatment.
|
Cognitive Behavioral Therapy
n=56 Participants
The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.
CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
|
Supportive Therapy
n=47 Participants
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period, sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance
|
|---|---|---|---|
|
Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients
left amygdala; Reappraise vs. Look Neut
|
.33 arbitrary units
Standard Deviation .91
|
.60 arbitrary units
Standard Deviation .69
|
.39 arbitrary units
Standard Deviation .54
|
|
Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients
left DLPFC; Reappraise vs. Look Neut
|
.26 arbitrary units
Standard Deviation .64
|
.51 arbitrary units
Standard Deviation .97
|
.50 arbitrary units
Standard Deviation .62
|
|
Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients
right DLPFC; Reappraise vs. Look Neut
|
.23 arbitrary units
Standard Deviation .64
|
.38 arbitrary units
Standard Deviation .95
|
.39 arbitrary units
Standard Deviation .67
|
|
Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients
left IFG; Reppraise vs. Look Neut
|
.56 arbitrary units
Standard Deviation .87
|
.51 arbitrary units
Standard Deviation .77
|
.57 arbitrary units
Standard Deviation .66
|
|
Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients
right IFG; Reappraise vs. Look Neut
|
.67 arbitrary units
Standard Deviation .83
|
.54 arbitrary units
Standard Deviation .77
|
.60 arbitrary units
Standard Deviation .73
|
|
Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients
right amygdala; Reappraise vs. Look Neut
|
.31 arbitrary units
Standard Deviation .98
|
.52 arbitrary units
Standard Deviation .74
|
.38 arbitrary units
Standard Deviation .57
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Participants included both participants with major depression and social anxiety. Primary outcomes did not include hypotheses related to differences between diagnostic groups; therefore, statistical analyses were collapsed across diagnostic groups.
Planned comparisons (i.e., paired t-test). Outcomes are parameter estimates (arbitrary units) of brain activity for a priori brain regions (amygdala, dorsolateral prefrontal cortex (DLPFC), inferior frontal gyrus (IFG)) comparing reappraising negative images ('Reappraise') to baseline condition (look at neutral images; 'Look Neut'). Not all participants who consented to the study completed this task at all time points. Reasons include dropping out of the study, COVID shutdowns, scheduling issues, and participants not consenting to perform task due to use of negative images. Higher values represent greater activation.
Outcome measures
| Measure |
Control
n=24 Participants
Healthy control participants did not receive treatment.
|
Cognitive Behavioral Therapy
n=42 Participants
The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.
CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
|
Supportive Therapy
n=28 Participants
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period, sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance
|
|---|---|---|---|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Baseline right amygdala; reappraise vs. look neut
|
23 arbitrary units
Standard Deviation 1.19
|
.54 arbitrary units
Standard Deviation .63
|
.37 arbitrary units
Standard Deviation .53
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Baseline left IFG; reappraise vs. look neut
|
.26 arbitrary units
Standard Deviation .69
|
.84 arbitrary units
Standard Deviation .89
|
.76 arbitrary units
Standard Deviation .63
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Week 12 left IFG; reappraise vs. look neut
|
.55 arbitrary units
Standard Deviation .60
|
.66 arbitrary units
Standard Deviation .86
|
.71 arbitrary units
Standard Deviation .47
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Week 12 right IFG; reappraise vs. look neut
|
.51 arbitrary units
Standard Deviation .59
|
.47 arbitrary units
Standard Deviation .83
|
.57 arbitrary units
Standard Deviation .92
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Baseline left amygdala; reappraise vs. look neut
|
.27 arbitrary units
Standard Deviation 1.10
|
.61 arbitrary units
Standard Deviation .63
|
.36 arbitrary units
Standard Deviation .49
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Week 12 left amygdala; reappraise vs. look neut
|
.23 arbitrary units
Standard Deviation .64
|
.47 arbitrary units
Standard Deviation .60
|
.44 arbitrary units
Standard Deviation .51
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Week 12 right amygdala; reappraise vs. look neut
|
.25 arbitrary units
Standard Deviation .56
|
.49 arbitrary units
Standard Deviation .76
|
.43 arbitrary units
Standard Deviation .50
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Baseline left DLPFC; reappraise vs. look neut
|
.10 arbitrary units
Standard Deviation .69
|
.58 arbitrary units
Standard Deviation .90
|
.55 arbitrary units
Standard Deviation .63
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Week 12 left DLPFC; reappraise vs. look neut
|
.45 arbitrary units
Standard Deviation .74
|
.38 arbitrary units
Standard Deviation .88
|
.41 arbitrary units
Standard Deviation .43
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Baseline right DLPFC; reappraise vs. look neut
|
.10 arbitrary units
Standard Deviation .70
|
.45 arbitrary units
Standard Deviation .95
|
.43 arbitrary units
Standard Deviation .71
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Week 12 right DLPFC; reappraise vs. look neut
|
.26 arbitrary units
Standard Deviation .74
|
.31 arbitrary units
Standard Deviation 1.05
|
.24 arbitrary units
Standard Deviation .64
|
|
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Baseline right IFG; reappraise vs. look neut
|
.40 arbitrary units
Standard Deviation .74
|
.53 arbitrary units
Standard Deviation .71
|
.63 arbitrary units
Standard Deviation .66
|
PRIMARY outcome
Timeframe: baselinePopulation: Primary outcomes did not include hypotheses related to differences between treatment arms (cognitive behavioral therapy and supportive therapy); therefore, analyses were collapsed across treatment arms and only included those who completed therapy in order to examine possible general psychotherapy predictors.
Outcomes are baseline parameter estimates (arbitrary units) of brain activity for a priori brain regions of interest (bilateral amygdala, bilateral dorsolateral prefrontal cortex ('DLPFC'), bilateral inferior frontal gyrus ('IFG')) comparing active conditions against 'baseline' condition (i.e., look at neutral images; 'Look Neut'). Active conditions are reappraising negative images ('Reappraise') and looking at negative images ('Look Neg'). The Reappraise vs. Look Neut and Look Neg vs. Look Neut are the contrasts of interest. Other outcome measure is symptom severity before and after psychotherapy collapsing across cognitive behavioral therapy and supportive therapy to examine general psychotherapy predictors across psychotherapies. Higher values (arbitrary units) represent greater activation. Aim 5 is a continuation of Aim 4 including symptom measures comprised of HAMD and LSAS composite score of maximum scaling method.
Outcome measures
| Measure |
Control
n=48 Participants
Healthy control participants did not receive treatment.
|
Cognitive Behavioral Therapy
n=36 Participants
The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.
CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
|
Supportive Therapy
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period, sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance
|
|---|---|---|---|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
left amygdala; Reappraise vs. Look Neut
|
.60 arbitrary units
Standard Deviation .72
|
.40 arbitrary units
Standard Deviation .54
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
right amygdala; Reappraise vs. Look Neut
|
.52 arbitrary units
Standard Deviation .77
|
.38 arbitrary units
Standard Deviation .58
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
left DLPFC; Reappraise vs. Look Neut
|
.56 arbitrary units
Standard Deviation 1.03
|
.57 arbitrary units
Standard Deviation .64
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
right DLPFC; Reappraise vs. Look Neut
|
.42 arbitrary units
Standard Deviation 1.01
|
.49 arbitrary units
Standard Deviation .68
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
right IFG; Look Neg vs. Look Neut
|
.16 arbitrary units
Standard Deviation .53
|
.35 arbitrary units
Standard Deviation .64
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
left IFG; Reappraise vs. Look Neut
|
.50 arbitrary units
Standard Deviation .82
|
.67 arbitrary units
Standard Deviation .68
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
right IFG; Reappraise vs. Look Neut
|
.56 arbitrary units
Standard Deviation .83
|
.70 arbitrary units
Standard Deviation .77
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
left amygdala; Look Neg vs. Look Neut
|
.25 arbitrary units
Standard Deviation .64
|
.37 arbitrary units
Standard Deviation .38
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
right amygdala; Look Neg vs. Look Neut
|
.21 arbitrary units
Standard Deviation .69
|
.34 arbitrary units
Standard Deviation .38
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
left DLPFC; Look Neg vs. Look Neut
|
.07 arbitrary units
Standard Deviation .72
|
.36 arbitrary units
Standard Deviation .65
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
right DLPFC; Look Neg vs. Look Neut
|
.00 arbitrary units
Standard Deviation .74
|
.21 arbitrary units
Standard Deviation .62
|
—
|
|
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
left IFG; Look Neg vs. Look Neut
|
.10 arbitrary units
Standard Deviation .57
|
.31 arbitrary units
Standard Deviation .68
|
—
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Primary outcomes did not include hypotheses related to differences between treatment arms (cognitive behavioral therapy and supportive therapy); therefore, analyses were collapsed across treatment arms and only included those who completed therapy in order to examine general psychotherapy predictors.
This aim is connected to Aim 4 and represents an additional predictor in the regression model. Data analysis results for Aim 4 apply to this data as well. Outcome measure is symptom severity before and after psychotherapy collapsing across cognitive behavioral therapy and supportive therapy. Symptom measures comprised social anxiety (LSAS) and depression (HAMD) composite score proportion of maximum scaling method which ranges from 0 to 1. Higher symptom severity scores represent worse symptoms.
Outcome measures
| Measure |
Control
n=48 Participants
Healthy control participants did not receive treatment.
|
Cognitive Behavioral Therapy
n=36 Participants
The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.
CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
|
Supportive Therapy
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period, sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance
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|---|---|---|---|
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Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
baseline symptom severity score
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.89 proportion of maximum scaling
Standard Deviation .25
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.83 proportion of maximum scaling
Standard Deviation .23
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—
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Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
post-treatment symptom severity score
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.48 proportion of maximum scaling
Standard Deviation .30
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.56 proportion of maximum scaling
Standard Deviation .31
|
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Adverse Events
Cognitive Behavioral Therapy (CBT)
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Supportive Therapy (ST)
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Behavioral Therapy (CBT)
n=61 participants at risk
The clinical psychologist will use a manualized CBT approach tailored to MDD or gSAD. Over a 12-week period sessions will include core CBT strategies -- psychoeducation, cognitive intervention (e.g., cognitive restructuring), behavioral changes (i.e., fear exposure, behavioral activation strategies) and relapse prevention.
CBT: CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
|
Supportive Therapy (ST)
n=57 participants at risk
The clinical psychologist will use an ST approach that resembles client-centered therapy of Carl Rogers (1951) which has been used as a control psychotherapy. The manual is based on supportive psychotherapy principles. Over a 12-week period sessions will emphasize reflective listening and elicitation of affect. In contrast to CBT, therapists allow patients to determine the focus of each session, pulling for emotion, validating emotions when possible, and offering empathetic comments. Therapists will refrain from delineating any CBT theoretical framework and avoided cognitive and behavioral techniques that might overlap with CBT.
ST: Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance
|
Control
n=50 participants at risk
Over a 12-week period, the control group will not receive treatment. Controls will complete EEG, MRI, and Neuropsychological assessments.
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|---|---|---|---|
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Investigations
Other Adverse Event
|
42.6%
26/61 • Number of events 58 • The Adverse Event data was collected over the course of the 15 weeks of participating in the research study. Regardless of the treatment arm, the patient participants were randomized to, adverse events were collected for every lab visit (EEG/MRI/Neuropsych evaluation) CBT/ST sessions, and a 6-month follow-up.
|
43.9%
25/57 • Number of events 57 • The Adverse Event data was collected over the course of the 15 weeks of participating in the research study. Regardless of the treatment arm, the patient participants were randomized to, adverse events were collected for every lab visit (EEG/MRI/Neuropsych evaluation) CBT/ST sessions, and a 6-month follow-up.
|
4.0%
2/50 • Number of events 2 • The Adverse Event data was collected over the course of the 15 weeks of participating in the research study. Regardless of the treatment arm, the patient participants were randomized to, adverse events were collected for every lab visit (EEG/MRI/Neuropsych evaluation) CBT/ST sessions, and a 6-month follow-up.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place