Trial Outcomes & Findings for Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health (NCT NCT05523453)
NCT ID: NCT05523453
Last Updated: 2026-08-31
Results Overview
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
COMPLETED
NA
70 participants
Baseline
2026-08-31
Participant Flow
The first participant was enrolled in March 2023, and the last participant was enrolled in October 2024 (average enrollment/month = 3.5 eligible participants). We recruited participants in and around the Dallas Fort Worth metroplex by disseminating information to mental health agencies, primary care offices, community partners, public places, and businesses. As needed, we used social media postings.
Participant milestones
| Measure |
Processing of Positive Memories Technique (PPMT)
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
27
|
33
|
|
Overall Study
NOT COMPLETED
|
9
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health
Baseline characteristics by cohort
| Measure |
Processing of Positive Memories Technique (PPMT)
n=36 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.61 years
STANDARD_DEVIATION 14.14 • n=14 Participants
|
32.06 years
STANDARD_DEVIATION 12.29 • n=36 Participants
|
31.31 years
STANDARD_DEVIATION 13.20 • n=324 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=14 Participants
|
27 Participants
n=36 Participants
|
56 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=14 Participants
|
7 Participants
n=36 Participants
|
14 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=14 Participants
|
10 Participants
n=36 Participants
|
22 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=14 Participants
|
24 Participants
n=36 Participants
|
48 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Positive and Negative Affect Schedule (PANAS-Negative)
|
23.58 scores on a subscale
STANDARD_DEVIATION 4.53 • n=14 Participants
|
25.41 scores on a subscale
STANDARD_DEVIATION 8.31 • n=36 Participants
|
24.44 scores on a subscale
STANDARD_DEVIATION 6.60 • n=324 Participants
|
|
PTSD Checklist for DSM-5
|
32.18 scores on a scale
STANDARD_DEVIATION 12.06 • n=14 Participants
|
33.25 scores on a scale
STANDARD_DEVIATION 12.55 • n=36 Participants
|
32.73 scores on a scale
STANDARD_DEVIATION 12.24 • n=324 Participants
|
|
Positive and Negative Affect Schedule (PANAS-Positive)
|
23.65 scores on a subscale
STANDARD_DEVIATION 6.42 • n=14 Participants
|
27.26 scores on a subscale
STANDARD_DEVIATION 6.42 • n=36 Participants
|
25.48 scores on a subscale
STANDARD_DEVIATION 6.63 • n=324 Participants
|
PRIMARY outcome
Timeframe: BaselineThe 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=36 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
|
32.18 scores on a scale
Standard Deviation 12.06
|
33.25 scores on a scale
Standard Deviation 12.55
|
PRIMARY outcome
Timeframe: Week 1 post-baseline during therapy sessionThe 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=36 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
|
30.85 scores on a scale
Standard Deviation 14.50
|
31.37 scores on a scale
Standard Deviation 13.90
|
PRIMARY outcome
Timeframe: Week 2 post-baseline during therapy sessionPopulation: The fewer number of participants compared to what is reported for Outcome Measures at the first and second timepoints are attributed to drop-outs from the study arms.
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=33 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
|
26.38 scores on a scale
Standard Deviation 14.64
|
26.67 scores on a scale
Standard Deviation 14.82
|
PRIMARY outcome
Timeframe: Week 3 post-baseline during therapy sessionPopulation: The fewer number of participants compared to what is reported for Outcome Measures at the first and second timepoints are attributed to drop-outs from the study arms.
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=28 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
|
22.41 scores on a scale
Standard Deviation 12.25
|
22.00 scores on a scale
Standard Deviation 12.77
|
PRIMARY outcome
Timeframe: Week 4 post-baseline during therapy sessionPopulation: The fewer number of participants compared to what is reported for Outcome Measures at the first and second timepoints are attributed to drop-outs from the study arms.
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=27 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
|
21.61 scores on a scale
Standard Deviation 13.26
|
18 scores on a scale
Standard Deviation 12.01
|
PRIMARY outcome
Timeframe: Week 5 post-baseline during therapy sessionPopulation: The fewer number of participants compared to what is reported for Outcome Measures at the first and second timepoints are attributed to drop-outs from the study arms.
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=27 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
|
17.77 scores on a scale
Standard Deviation 14.50
|
16.88 scores on a scale
Standard Deviation 10.74
|
PRIMARY outcome
Timeframe: 1 week after the last therapy session, at week 6 post-baselineThe 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=28 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=33 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
|
16.44 scores on a scale
Standard Deviation 13.19
|
16.18 scores on a scale
Standard Deviation 16.03
|
PRIMARY outcome
Timeframe: 3-months posttreatment completion, at week 18 post-baselineThe 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity. Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=27 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=33 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
|
17 scores on a scale
Standard Deviation 14.71
|
16.78 scores on a scale
Standard Deviation 14.71
|
SECONDARY outcome
Timeframe: 3 times each day for 2 consecutive days prior to first therapy sessionPopulation: Some saliva samples were either not provided by participants or data were not analyzed after following pre-determined data cleaning rules.
Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days both prior to PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening. For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated. The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable. Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=35 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=33 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Awakening Salivary Alpha Amylase to Cortisol Ratio
|
3.96 ratio
Standard Deviation 1.20
|
4.22 ratio
Standard Deviation .96
|
SECONDARY outcome
Timeframe: 3 times each day for 2 consecutive days after the last therapy sessionPopulation: Some saliva samples were either not provided by participants or data were not analyzed after following pre-determined data cleaning rules. There were some study dropouts.
Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days one week following PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening. For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated. The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable. Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=23 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=30 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Awakening Salivary Alpha Amylase to Cortisol Ratio
|
3.95 ratio
Standard Deviation 1.23
|
4.28 ratio
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: BaselineThe 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=36 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Positive and Negative Affect Schedule
Positive affect subscale
|
23.65 scores on a subscale
Standard Deviation 6.42
|
27.26 scores on a subscale
Standard Deviation 6.42
|
|
Positive and Negative Affect Schedule
Negative affect subscale
|
23.58 scores on a subscale
Standard Deviation 4.53
|
25.41 scores on a subscale
Standard Deviation 8.31
|
SECONDARY outcome
Timeframe: Week 1 post-baseline during therapy sessionThe 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=36 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Positive and Negative Affect Schedule
Positive affect subscale
|
24.52 scores on a subscale
Standard Deviation 6.80
|
25.56 scores on a subscale
Standard Deviation 9.03
|
|
Positive and Negative Affect Schedule
Negative affect subscale
|
22.06 scores on a subscale
Standard Deviation 5.98
|
25.32 scores on a subscale
Standard Deviation 8.40
|
SECONDARY outcome
Timeframe: Week 2 post-baseline during therapy sessionThe 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=33 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Positive and Negative Affect Schedule
Positive affect subscale
|
22.94 scores on a subscale
Standard Deviation 5.90
|
27.94 scores on a subscale
Standard Deviation 7.75
|
|
Positive and Negative Affect Schedule
Negative affect subscale
|
22.09 scores on a subscale
Standard Deviation 7.58
|
23.62 scores on a subscale
Standard Deviation 8.91
|
SECONDARY outcome
Timeframe: Week 3 post-baseline during therapy sessionThe 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=28 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Positive and Negative Affect Schedule
Positive affect subscale
|
22.94 scores on a subscale
Standard Deviation 5.12
|
25.88 scores on a subscale
Standard Deviation 7.97
|
|
Positive and Negative Affect Schedule
Negative affect subscale
|
21.15 scores on a subscale
Standard Deviation 5.65
|
22.15 scores on a subscale
Standard Deviation 7.86
|
SECONDARY outcome
Timeframe: Week 4 post-baseline during therapy sessionThe 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=27 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Positive and Negative Affect Schedule
Positive affect subscale
|
24.15 scores on a subscale
Standard Deviation 6.25
|
28.56 scores on a subscale
Standard Deviation 10.21
|
|
Positive and Negative Affect Schedule
Negative affect subscale
|
18.37 scores on a subscale
Standard Deviation 5.56
|
21.52 scores on a subscale
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: Week 5 post-baseline during therapy sessionThe 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=27 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Positive and Negative Affect Schedule
Positive affect subscale
|
23.06 scores on a subscale
Standard Deviation 7.23
|
29 scores on a subscale
Standard Deviation 10.86
|
|
Positive and Negative Affect Schedule
Negative affect subscale
|
17.74 scores on a subscale
Standard Deviation 6.64
|
21.38 scores on a subscale
Standard Deviation 8.42
|
SECONDARY outcome
Timeframe: 1 week after the last therapy session, at week 6 post-baselineThe 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=28 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=33 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Positive and Negative Affect Schedule
Positive affect subscale
|
23.29 scores on a subscale
Standard Deviation 6.85
|
28.96 scores on a subscale
Standard Deviation 11.03
|
|
Positive and Negative Affect Schedule
Negative affect subscale
|
16.39 scores on a subscale
Standard Deviation 5.17
|
19.28 scores on a subscale
Standard Deviation 7.58
|
SECONDARY outcome
Timeframe: 3-months posttreatment completion, at week 18 post-baselineThe 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively.
Outcome measures
| Measure |
Processing of Positive Memories Technique (PPMT)
n=27 Participants
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=33 Participants
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Positive and Negative Affect Schedule
Positive affect subscale
|
25.73 scores on a subscale
Standard Deviation 6.59
|
30.40 scores on a subscale
Standard Deviation 8.68
|
|
Positive and Negative Affect Schedule
Negative affect subscale
|
17.96 scores on a subscale
Standard Deviation 6.91
|
19.55 scores on a subscale
Standard Deviation 7.76
|
Adverse Events
Processing of Positive Memories Technique (PPMT)
Supportive Counseling (SC)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Processing of Positive Memories Technique (PPMT)
n=36 participants at risk
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
|
Supportive Counseling (SC)
n=34 participants at risk
Participants receive 5 60-minute supportive counseling (SC) sessions. SC includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
|
|---|---|---|
|
Psychiatric disorders
Increase in distress
|
27.8%
10/36 • From enrollment until the 3 month follow up timepoint, up to approximately 18 or 21 weeks of the study (contingent on whether the participant completed all therapy sessions in 5 or 9 weeks).
The definition of adverse events by the U.S. Department of Health and Human Services was used. Research assistants monitored AEs throughout each study phase. AEs were recorded on a worksheet that included the date, whether they were expected or not, severity rating, brief narrative summary, determination of whether a causal relationship existed between the study procedures and the event, and what action was taken by the research team. Systematic and non-systematic assessment was used.
|
17.6%
6/34 • From enrollment until the 3 month follow up timepoint, up to approximately 18 or 21 weeks of the study (contingent on whether the participant completed all therapy sessions in 5 or 9 weeks).
The definition of adverse events by the U.S. Department of Health and Human Services was used. Research assistants monitored AEs throughout each study phase. AEs were recorded on a worksheet that included the date, whether they were expected or not, severity rating, brief narrative summary, determination of whether a causal relationship existed between the study procedures and the event, and what action was taken by the research team. Systematic and non-systematic assessment was used.
|
|
Psychiatric disorders
Suicidal ideation
|
5.6%
2/36 • From enrollment until the 3 month follow up timepoint, up to approximately 18 or 21 weeks of the study (contingent on whether the participant completed all therapy sessions in 5 or 9 weeks).
The definition of adverse events by the U.S. Department of Health and Human Services was used. Research assistants monitored AEs throughout each study phase. AEs were recorded on a worksheet that included the date, whether they were expected or not, severity rating, brief narrative summary, determination of whether a causal relationship existed between the study procedures and the event, and what action was taken by the research team. Systematic and non-systematic assessment was used.
|
20.6%
7/34 • From enrollment until the 3 month follow up timepoint, up to approximately 18 or 21 weeks of the study (contingent on whether the participant completed all therapy sessions in 5 or 9 weeks).
The definition of adverse events by the U.S. Department of Health and Human Services was used. Research assistants monitored AEs throughout each study phase. AEs were recorded on a worksheet that included the date, whether they were expected or not, severity rating, brief narrative summary, determination of whether a causal relationship existed between the study procedures and the event, and what action was taken by the research team. Systematic and non-systematic assessment was used.
|
|
General disorders
Psychological or physical health issue
|
2.8%
1/36 • From enrollment until the 3 month follow up timepoint, up to approximately 18 or 21 weeks of the study (contingent on whether the participant completed all therapy sessions in 5 or 9 weeks).
The definition of adverse events by the U.S. Department of Health and Human Services was used. Research assistants monitored AEs throughout each study phase. AEs were recorded on a worksheet that included the date, whether they were expected or not, severity rating, brief narrative summary, determination of whether a causal relationship existed between the study procedures and the event, and what action was taken by the research team. Systematic and non-systematic assessment was used.
|
2.9%
1/34 • From enrollment until the 3 month follow up timepoint, up to approximately 18 or 21 weeks of the study (contingent on whether the participant completed all therapy sessions in 5 or 9 weeks).
The definition of adverse events by the U.S. Department of Health and Human Services was used. Research assistants monitored AEs throughout each study phase. AEs were recorded on a worksheet that included the date, whether they were expected or not, severity rating, brief narrative summary, determination of whether a causal relationship existed between the study procedures and the event, and what action was taken by the research team. Systematic and non-systematic assessment was used.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place