Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health

Study Overview
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Brief Summary
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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.

Official Title
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Examination and Refinement of a Novel Treatment for Posttraumatic Stress Disorder: Processing of Positive Memories Technique (PPMT)

Conditions
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Stress Disorders, Post-Traumatic, Affect, Memory

Intervention / Treatment
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* Behavioral: Processing of Positive Memories Technique (PPMT)
* Behavioral: Supportive Counseling (SC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Processing of Positive Memories Technique (PPMT)<br>Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual. | Behavioral: Processing of Positive Memories Technique (PPMT)<br>* 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.<br>|
| Active Comparator: Supportive Counseling (SC)<br>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. | Behavioral: Supportive Counseling (SC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Checklist for DSM-5 scores | 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 | 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 | 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 | 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 | 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 | 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 | PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely. | 1 week after last therapy session | 
| Posttraumatic Stress Disorder Checklist for DSM-5 scores | PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely. | 3-month post treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva Samples | Salivary alpha amylase and cortisol output will be assessed. | 3 times each day for 2 consecutive days prior to first therapy session | 
| Saliva Samples | Salivary alpha amylase and cortisol output will be assessed. | 3 times each day for 2 consecutive days after the last therapy session | 
| Positive and Negative Affect Schedule | 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 | 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 | 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 | 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 | 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 | 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 | 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 |