- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06680193
Therapeutic Effects of the Processing of Positive Memories Technique on Posttrauma Health (PPMT)
Daily Affect and Cognition Impacts of Processing of Positive Memories Technique (PPMT) in a Trauma-Exposed Community Sample
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Post-traumatic stress disorder (PTSD) is primarily a memory encoding- and retrieval-based disorder. If untreated, there are significant physical, psychological, social, and economic impacts for an individual, their families, and the society broadly. Research demonstrates that positive memory processes contribute to the etiology and maintenance of PTSD symptoms. Indeed, difficulties in retrieving and discussing positive memories are amplified among individuals with PTSD. Further, interventions capitalizing on (positive) memory retrieval have been linked to enhanced psychological well-being.
Considering this literature, the Processing of Positive Memories Technique (PPMT) was developed as a promising new treatment approach for posttraumatic stress disorder (PTSD), which involves detailed narration and processing of specific positive autobiographical memories. This study uses an innovative research protocol that combines case-series design and daily diary approaches to the effects of PPMT on daily affect, daily cognitions, and daily PTSD symptoms. It is hypothesized that at the daily level, in comparison to their an individual's pre-PPMT levels, following the PPMT intervention, participants will report (1) a lower count of endorsed daily PTSD symptoms, (2) increases in daily positive affect and decreases in daily negative affect, (3) increases in positive affect reactivity to daily positive events, and (4) decreases in daily posttrauma cognitions.
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, 76201
- University of North Texas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being aged between 18 and 65 years
- endorsing a trauma with posttrauma symptoms
- access to an electronic device with internet capabilities
- working knowledge of English
- being a current resident of the Dallas Fort Worth metroplex
- willingness and availability to participate in approximately 10 weeks of this study (including 4 therapy sessions)
- willingness to be video-recorded during sessions for quality control purposes
Exclusion Criteria:
- active suicidal plan, suicidal attempt, homicidal plan, or homicidal attempt (past 3 months including current)
- currently in therapy with a mental health provider
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Processing of Positive Memories Technique
PPMT was administered as a 4-session protocol in this arm.
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PPMT was administered weekly as a 4-session protocol.
In session 1, participants receive psychoeducation on PTSD symptoms, an overview of PPMT, and are assessed for psychological symptoms.
Sessions 1-4 involve the detailed processing of a salient positive autobiographical memory to elicit "values, affect, strengths, and thoughts" related to that positive memory.
Homework assignments include listening to an audio recording of that memory, completing a "values, affect, strengths, and thoughts" log, and engaging in a behavioral activity.
In session 4, the therapist also reviews psychological symptoms and addresses termination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Daily negative and positive affect levels
Time Frame: Each day for 21 days prior to and after the intervention and each survey references the past 24 hours
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Daily Positive and Negative Affect are assessed by rating the extent of four positive (excited, cheerful, satisfied, relaxed) and six negative (stressed, irritated, anxious, sad, hopeless, insecure) emotions.
This is adapted from the 20-item Positive and Negative Affect Scale.
The total positive affect subscale score can range from 1 to 20, with higher scores reflecting more positive affect levels.
The total negative affect subscale score can range from 1 to 30, with higher scores reflecting more negative affect.
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Each day for 21 days prior to and after the intervention and each survey references the past 24 hours
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Daily positive events
Time Frame: Each day for 21 days prior to and after the intervention and each survey references the past 24 hours
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Daily positive events is measured by 1 item which asked participants to think about the most positive event of the day and rate how pleasant it was.
The score can range from 1 to 4, with higher scores reflecting that the event was more pleasant.
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Each day for 21 days prior to and after the intervention and each survey references the past 24 hours
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Daily posttrauma cognitions
Time Frame: Each day for 21 days prior to and after the intervention and each survey references the past 24 hours
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A 9-item brief version of the Posttraumatic Cognitions Inventory (PTCI-9) will measure trauma-related thoughts/beliefs with the time frame modified to 'in the last 24 hours.'
The total raw score can range from 1 to 63, with higher scores reflecting endorsement of more negative posttrauma cognitions.
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Each day for 21 days prior to and after the intervention and each survey references the past 24 hours
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Daily PTSD symptoms
Time Frame: Each day for 21 days prior to and after the intervention and each survey references the past 24 hours
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Daily-life version of the Primary Care-PTSD-5 screen (PC-PTSD-5) will assess daily PTSD symptoms with the time frame modified to 'in the last 24 hours.'
The total score can range from 0 to 5, with higher scores reflecting endorsement of more PTSD symptoms.
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Each day for 21 days prior to and after the intervention and each survey references the past 24 hours
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Number of retrieved positive memories
Time Frame: Baseline survey approximately 4 weeks prior to the intervention
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AMT assesses the number of retrieved positive memories by using five cue words followed by a prompt to recall a personally meaningful and specific memory of an event that took place within any 24-hour period.
The total score could range from 0 to 5, with higher scores indicating more number of retrieved positive memories.
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Baseline survey approximately 4 weeks prior to the intervention
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Number of retrieved positive memories
Time Frame: 1 week after intervention sessions
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AMT assesses the number of retrieved positive memories by using five cue words followed by a prompt to recall a personally meaningful and specific memory of an event that took place within any 24-hour period.
The total score could range from 0 to 5, with higher scores indicating more number of retrieved positive memories.
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1 week after intervention sessions
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive Emotion Dysregulation
Time Frame: Baseline survey approximately 4 weeks prior to the intervention
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The Difficulties in Emotional Regulation Scale-Positive Emotions is a 13-item self-report measure that examines dysregulation of positive emotions.
The total score could range from 1 to 65, with higher scores indicating more positive emotion dysregulation.
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Baseline survey approximately 4 weeks prior to the intervention
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Positive Emotion Dysregulation
Time Frame: 1 week after intervention sessions
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The Difficulties in Emotional Regulation Scale-Positive Emotions is a 13-item self-report measure that examines dysregulation of positive emotions.
The total score could range from 1 to 65, with higher scores indicating more positive emotion dysregulation.
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1 week after intervention sessions
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Positive Emotion Dysregulation
Time Frame: At each of the 4 weekly intervention sessions and each survey references the past week
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The Difficulties in Emotional Regulation Scale-Positive Emotions is a 13-item self-report measure that examines dysregulation of positive emotions.
The total score could range from 1 to 65, with higher scores indicating more positive emotion dysregulation.
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At each of the 4 weekly intervention sessions and each survey references the past week
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PTSD symptom severity
Time Frame: Baseline survey approximately 4 weeks prior to the intervention
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The PTSD Checklist for DSM-5 is a 20-item self-report measure that will be used to evaluate PTSD symptom severity in relation to the worst trauma.
The total score could range from 0 to 80, with higher scores reflecting more PTSD symptom severity.
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Baseline survey approximately 4 weeks prior to the intervention
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PTSD symptom severity
Time Frame: 1 week after intervention sessions
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The PTSD Checklist for DSM-5 is a 20-item self-report measure that will be used to evaluate PTSD symptom severity in relation to the worst trauma.
The total score could range from 0 to 80, with higher scores reflecting more PTSD symptom severity.
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1 week after intervention sessions
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PTSD symptom severity
Time Frame: At each of the 4 weekly intervention sessions and each survey references the past week
|
The PTSD Checklist for DSM-5 is a 20-item self-report measure that will be used to evaluate PTSD symptom severity in relation to the worst trauma.
The total score could range from 0 to 80, with higher scores reflecting more PTSD symptom severity.
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At each of the 4 weekly intervention sessions and each survey references the past week
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Collaborators and Investigators
Collaborators
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 (Estimated)
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
- IRB-21-420
- 2020017 (Other Grant/Funding Number: United States-Israel Binational Science Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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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