- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523453
Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health
Examination and Refinement of a Novel Treatment for Posttraumatic Stress Disorder: Processing of Positive Memories Technique (PPMT)
Posttraumatic stress disorder (PTSD) has devastating health consequences. Evidence-based PTSD interventions address the substantial burden of PTSD on the health of individuals and societies; however, several individuals receiving these interventions drop out and not all individuals experience improvement in PTSD symptoms. Moreover, these current PTSD interventions primarily target trauma memories. Notably, growing evidence suggests that PTSD symptoms are related to difficulties in the encoding and retrieving of positive memories as well.
Thus, the proposed study will examine effects of and targets underlying a novel PTSD technique focused on narrating and detailing positive memories - Processing of Positive Memories Technique (PPMT). Methodologically, 70 individuals will be randomly assigned to PPMT vs. Supportive Counseling (SC) for this study.
The aims of the proposed study include (1) examining PPMT's effects on PTSD symptom severity and stress systems' dysregulation (i.e., awakening salivary alpha amylase [sAA] and cortisol); (2) examining mechanisms underlying PPMT's effects; and (3) refining PPMT. It is hypothesized that the PPMT arm will report greater decreases in PTSD severity and sAA/cortisol ratios. Further, it is hypothesized that PPMT-related improved affect will mediate the association between study arm (PPMT vs. SC) and changes in PTSD severity. Lastly, feedback will be obtained from study participants on PPMT's feasibility, format, and content to refine PPMT.
The proposed study may contribute preliminary evidence on the potential significance of targeting positive memories in PTSD interventions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Texas
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Denton, Texas, United States, 76203
- University of North Texas
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-65 years old
- Willing/able to provide informed consent
- Past month DSM-5 posttraumatic stress disorder (PTSD) diagnosis
- Working knowledge of English
Exclusion Criteria:
- Active suicidal intent or attempts
- Active psychosis
- Currently receiving mental health therapy (past 3 months)
- Dosage changes in psychiatric medications (past 3 months)
- Currently pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
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PPMT comprises of 5 sessions focused on identifying and processing positive memories.
In Session 1-5, participants narrate details of one positive memory, and process the positive memory to elicit positive values, affect, strengths, and thoughts.
|
|
Active Comparator: 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.
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SC is a 5-session, active and non-specific treatment administered weekly, which includes a discussion of the daily monitoring diary and exploration of current issues and concerns.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Time Frame: Baseline
|
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
|
Baseline
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Time Frame: Week 1 post-baseline during therapy session
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PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
|
Week 1 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Time Frame: Week 2 post-baseline during therapy session
|
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
|
Week 2 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Time Frame: Week 3 post-baseline during therapy session
|
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
|
Week 3 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Time Frame: Week 4 post-baseline during therapy session
|
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
|
Week 4 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Time Frame: Week 5 post-baseline during therapy session
|
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
|
Week 5 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Time Frame: 1 week after last therapy session
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PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
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1 week after last therapy session
|
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Posttraumatic Stress Disorder Checklist for DSM-5 scores
Time Frame: 3-month post treatment completion
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PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
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3-month post treatment completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Saliva Samples
Time Frame: 3 times each day for 2 consecutive days prior to first therapy session
|
Salivary alpha amylase and cortisol output will be assessed.
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3 times each day for 2 consecutive days prior to first therapy session
|
|
Saliva Samples
Time Frame: 3 times each day for 2 consecutive days after the last therapy session
|
Salivary alpha amylase and cortisol output will be assessed.
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3 times each day for 2 consecutive days after the last therapy session
|
|
Positive and Negative Affect Schedule
Time Frame: Baseline
|
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
|
Baseline
|
|
Positive and Negative Affect Schedule
Time Frame: Week 1 post-baseline during therapy session
|
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
|
Week 1 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Time Frame: Week 2 post-baseline during therapy session
|
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
|
Week 2 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Time Frame: Week 3 post-baseline during therapy session
|
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
|
Week 3 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Time Frame: Week 4 post-baseline during therapy session
|
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
|
Week 4 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Time Frame: Week 5 post-baseline during therapy session
|
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
|
Week 5 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Time Frame: 1 week after last therapy session
|
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
|
1 week after last therapy session
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ateka Contractor, PHD, University of North Texas Health Science Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R15MH129773-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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