Trial Outcomes & Findings for A Self-Management Program for Completers of Trauma-Focused Therapy for PTSD (NCT NCT03225859)
NCT ID: NCT03225859
Last Updated: 2021-02-08
Results Overview
Measures treatment rationale credibility in clinical outcome studies (range 1-9; higher scores = higher credibility).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Prior to first self-management session (baseline)
Results posted on
2021-02-08
Participant Flow
We identified 23 eligible patients. Twelve (52%) veterans enrolled, five (22%) declined participation, five (22%) were eligible but not contacted because they were not identified prior to their final PE/CPT session, and one (4%) veteran was unreachable. Eighty Veterans who were not eligible for EMPOWER were also identified in our screening procedures; failure to complete PE/CPT (n = 41; 51%) and participation in co-occurring studies (n = 12; 29%) were the most common reasons for exclusion.
Participant milestones
| Measure |
Self-Management Program
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
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Overall Study
STARTED
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12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participant age not collected for this study.
Baseline characteristics by cohort
| Measure |
Self-Management Program
n=12 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
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Sex: Female, Male
Female
|
4 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
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8 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
|
Service Era
Iraq & Afghanistan Veterans
|
9 Participants
n=12 Participants
|
|
Service Era
Gulf War 1/Post-Vietnam Era Veterans
|
1 Participants
n=12 Participants
|
|
Service Era
Vietnam Veterans
|
2 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Prior to first self-management session (baseline)Measures treatment rationale credibility in clinical outcome studies (range 1-9; higher scores = higher credibility).
Outcome measures
| Measure |
Self-Management Program
n=12 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
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Credibility-Expectancy Scale (Credibility Subscale)
|
6.39 score on a scale
Standard Deviation 1.73
|
PRIMARY outcome
Timeframe: Three months after first self-management session (follow-up)Population: Includes the 9 patients who provided data for this post-treatment assessment timepoint
Measures client satisfaction with mental health services (range = 8-32; higher scores = higher satisfaction)
Outcome measures
| Measure |
Self-Management Program
n=9 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
|
Client Satisfaction Scale
|
29.67 score on a scale
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)Population: Data from all participants who completed the post-treatment survey.
Measures patients' self-efficacy for managing PTSD symptoms; range = 1-5 (higher scores = greater perceived control; change from pre- to post-intervention reported.
Outcome measures
| Measure |
Self-Management Program
n=9 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
|
|---|---|
|
Change From Baseline in Illness Perception Questionnaire - Revised (Personal Control Subscale)
|
0.33 score on a scale
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)Population: Data reported for all participants who completed post-treatment survey
Measures DSM-5 PTSD symptoms; Range = 0-80; higher scores = more severe symptoms; change score from pre- to post-treatment reported
Outcome measures
| Measure |
Self-Management Program
n=9 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
|
Change From Baseline on PTSD Checklist - 5
|
-1.67 score on a scale
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)Population: Participants who provided complete data in post-treatment survey
Measures symptoms of depression; range = 0-27; higher scores = more severe symptoms; pre- to post-treatment change score reported
Outcome measures
| Measure |
Self-Management Program
n=7 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
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Change From Baseline on Patient Health Questionnaire - 9
|
-0.14 score on a scale
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)Population: Data reported for all participants who provided complete post-treatment data.
Measures patients' perceived mental health; range 1-5; lower scores = better perceived mental health
Outcome measures
| Measure |
Self-Management Program
n=7 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
|
|---|---|
|
Change From Baseline on Recovery Orientation Scale (Current Mental Health Subscale)
|
-1.0 score on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)Population: Data for all participants who provided complete post-treatment survey data
Measures patients' current quality of life; higher score = better quality of life; range = 0-100. Change score from pre- to post-treatment reported
Outcome measures
| Measure |
Self-Management Program
n=8 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
|
|---|---|
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Change From Baseline on World Health Organization Quality of Life - BREF
|
6.62 Change of score on scale
Standard Deviation 6.25
|
SECONDARY outcome
Timeframe: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)Population: Data from participants who provided complete post-treatment survey data
Measures patients' community engagement; range: 0-4; higher scores = more difficulty; change score from pre- to post-intervention reported
Outcome measures
| Measure |
Self-Management Program
n=9 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
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Change From Baseline on Military to Civilian Questionnaire
|
-0.27 score on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Prior to first self-management session (baseline) and three months after first self-management session (follow-up)Population: Data for participants who provided complete post-treatment survey data
Measure of PTSD-related psychosocial functional impairment; higher scores = more severe; range = 0-49; change from pre- to post-treatment reported
Outcome measures
| Measure |
Self-Management Program
n=9 Participants
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
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Change From Baseline on Brief Inventory of Psychosocial Functioning
|
4.44 units on a scale
Standard Deviation 14.02
|
Adverse Events
Self-Management Program
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Self-Management Program
n=12 participants at risk
Patients in this arm will receive the therapist assisted self-management intervention following completion of trauma-focused therapy for PTSD.
Self-Management Program: This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
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|---|---|
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Cardiac disorders
Hospitalization
|
8.3%
1/12 • 3 months
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Other adverse events
Adverse event data not reported
Additional Information
Shannon Kehle-Forbes, PhD
Minneapolis VA Medical Center
Phone: 612-467-4772
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place