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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05523453
• Other study ID #: R15MH129773-01A1
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: January 2025

Study information

• Verified date: August 2023
• Source: University of North Texas, Denton, TX
• Contact: Holly Wang
• Phone: 940-369-8634
• Email: hui.wang[@]unt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Affect
• Memory
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Processing of Positive Memories Technique (PPMT)
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.
• Supportive Counseling (SC)
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.

Locations

Country	Name	City	State
United States	University of North Texas	Denton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of North Texas, Denton, TX

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Saliva Samples	Salivary alpha amylase and cortisol output will be assessed.	3 times each day for 2 consecutive days prior to first therapy session
Secondary	Saliva Samples	Salivary alpha amylase and cortisol output will be assessed.	3 times each day for 2 consecutive days after the last therapy session
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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