Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health
Primary Purpose
Stress Disorders, Post-Traumatic, Affect, Memory
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Processing of Positive Memories Technique (PPMT)
Supportive Counseling (SC)
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
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
Sites / Locations
- University of North TexasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Processing of Positive Memories Technique (PPMT)
Supportive Counseling (SC)
Arm Description
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Saliva Samples
Salivary alpha amylase and cortisol output will be assessed.
Saliva Samples
Salivary alpha amylase and cortisol output will be assessed.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05523453
First Posted
August 24, 2022
Last Updated
August 21, 2023
Sponsor
University of North Texas, Denton, TX
1. Study Identification
Unique Protocol Identification Number
NCT05523453
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Texas, Denton, TX
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Affect, Memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Processing of Positive Memories Technique (PPMT)
Arm Type
Active Comparator
Arm Description
Participants receive 5 60-minute Processing of Positive Memories Technique (PPMT) sessions for PTSD following the treatment procedures as outlined in PPMT therapy manual.
Arm Title
Supportive Counseling (SC)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Processing of Positive Memories Technique (PPMT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Counseling (SC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Description
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
Time Frame
Baseline
Title
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Description
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
Time Frame
Week 1 post-baseline during therapy session
Title
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Description
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
Time Frame
Week 2 post-baseline during therapy session
Title
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Description
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
Time Frame
Week 3 post-baseline during therapy session
Title
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Description
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
Time Frame
Week 4 post-baseline during therapy session
Title
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Description
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
Time Frame
Week 5 post-baseline during therapy session
Title
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Description
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
Time Frame
1 week after last therapy session
Title
Posttraumatic Stress Disorder Checklist for DSM-5 scores
Description
PTSD symptom severity is assessed using 20 items with response options ranging from 0 = not at all to 4 = extremely.
Time Frame
3-month post treatment completion
Secondary Outcome Measure Information:
Title
Saliva Samples
Description
Salivary alpha amylase and cortisol output will be assessed.
Time Frame
3 times each day for 2 consecutive days prior to first therapy session
Title
Saliva Samples
Description
Salivary alpha amylase and cortisol output will be assessed.
Time Frame
3 times each day for 2 consecutive days after the last therapy session
Title
Positive and Negative Affect Schedule
Description
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
Time Frame
Baseline
Title
Positive and Negative Affect Schedule
Description
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
Time Frame
Week 1 post-baseline during therapy session
Title
Positive and Negative Affect Schedule
Description
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
Time Frame
Week 2 post-baseline during therapy session
Title
Positive and Negative Affect Schedule
Description
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
Time Frame
Week 3 post-baseline during therapy session
Title
Positive and Negative Affect Schedule
Description
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
Time Frame
Week 4 post-baseline during therapy session
Title
Positive and Negative Affect Schedule
Description
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
Time Frame
Week 5 post-baseline during therapy session
Title
Positive and Negative Affect Schedule
Description
Positive and negative affect is assessed using 20 items with response options ranging from 1 = not at all/very slightly to 5 = extremely.
Time Frame
1 week after last therapy session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holly Wang
Phone
940-369-8634
Email
hui.wang@unt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ateka Contractor, PHD
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Texas
City
Denton
State/Province
Texas
ZIP/Postal Code
76203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ateka Contractor, PhD
Phone
940-369-8228
Email
ateka.contractor@unt.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Examining Effects of a Therapeutic Focus on Positive Memories on Post-Trauma Health
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