Clinical trial NCT05523453: Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health
Official title: Examination and Refinement of a Novel Treatment for Posttraumatic Stress Disorder: Processing of Positive Memories Technique (PPMT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Affect
Memory
Lead sponsor: University of North Texas, Denton, TX
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist for DSM-5 scores
timeFrame: Baseline
measure: Posttraumatic Stress Disorder Checklist for DSM-5 scores
timeFrame: Week 1 post-baseline during therapy session
measure: Posttraumatic Stress Disorder Checklist for DSM-5 scores
timeFrame: Week 2 post-baseline during therapy session
measure: Posttraumatic Stress Disorder Checklist for DSM-5 scores
timeFrame: Week 3 post-baseline during therapy session
measure: Posttraumatic Stress Disorder Checklist for DSM-5 scores
timeFrame: Week 4 post-baseline during therapy session
measure: Posttraumatic Stress Disorder Checklist for DSM-5 scores
timeFrame: Week 5 post-baseline during therapy session
measure: Posttraumatic Stress Disorder Checklist for DSM-5 scores
timeFrame: 1 week after last therapy session
measure: Posttraumatic Stress Disorder Checklist for DSM-5 scores
timeFrame: 3-month post treatment completion
Secondary outcomes:
measure: Saliva Samples
timeFrame: 3 times each day for 2 consecutive days prior to first therapy session
measure: Saliva Samples
timeFrame: 3 times each day for 2 consecutive days after the last therapy session
measure: Positive and Negative Affect Schedule
timeFrame: Baseline
measure: Positive and Negative Affect Schedule
timeFrame: Week 1 post-baseline during therapy session
measure: Positive and Negative Affect Schedule
timeFrame: Week 2 post-baseline during therapy session
measure: Positive and Negative Affect Schedule
timeFrame: Week 3 post-baseline during therapy session
measure: Positive and Negative Affect Schedule
timeFrame: Week 4 post-baseline during therapy session
measure: Positive and Negative Affect Schedule
timeFrame: Week 5 post-baseline during therapy session
measure: Positive and Negative Affect Schedule
timeFrame: 1 week after last therapy session
Other outcomes:
Locations:
city: Denton
country: United States
facility: University of North Texas
state: Texas
Study officials:
affiliation: University of North Texas Health Science Center
name: Ateka Contractor, PHD
role: PRINCIPAL_INVESTIGATOR
References: