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Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Memory Flexibility training (MemFlex)
Sponsored by
Medical Research Council Cognition and Brain Sciences Unit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Posttraumatic Stress Disorder (as indexed by the Farsi version of the Structured Clinical Interview for DSM disorders [SCID])
  • Aged over 18 years

Exclusion Criteria:

  • Lack of oral and/or written fluency in Farsi
  • Traumatic brain injury or cognitive impairment, indexed via self-report
  • Current experience of psychosis, indexed by SCID

Sites / Locations

  • Institute for Cognitive Science Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Memory Flexibility Training (MemFlex)

Waitlist control

Arm Description

The MemFlex programme has been adapted from the initial format addressing depression-related memory distortions to facilitate completion with individuals experiencing posttraumatic stress. The workbook and associated materials have also been translated from English to Farsi. The programme consists of one researcher-facilitated session and eight self-guided workbook-based sessions that train memory retrieval skills and are completed over a one month period.

After randomisation, the waitlist control group will be informed that they have been placed on a waiting list for the intervention. The participants will complete the baseline assessment and receive no further contact from the researcher until the post assessment one month later, followed by the follow-up assessment three months later. After the three month assessment, wait listed participants will receive the intervention. No further assessments will be completed.

Outcomes

Primary Outcome Measures

Autobiographical memory
Number of correct responses on the Alternating Instructions Autobiographical Memory Test- Farsi version

Secondary Outcome Measures

PTSD symptoms at post-intervention
Total score (range - 0-80) on the Farsi version of the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders- Fifth Edition
PTSD symptoms at follow-up
Total score (range - 0-80) on the Farsi version of the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders- Fifth Edition

Full Information

First Posted
February 23, 2018
Last Updated
June 16, 2020
Sponsor
Medical Research Council Cognition and Brain Sciences Unit
Collaborators
Institute for Cognitive Science Studies, Iran, Kharazmi University
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1. Study Identification

Unique Protocol Identification Number
NCT03634709
Brief Title
Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder
Official Title
A Randomised Controlled Trial of Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 19, 2018 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
May 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Council Cognition and Brain Sciences Unit
Collaborators
Institute for Cognitive Science Studies, Iran, Kharazmi University

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
The experience of trauma not only impacts the way an individual thinks and feels, but can also produce changes in the way someone remembers their personal past. It is not only memories of the trauma that are affected- avoidance of trauma memories can also lead to memories of other events becoming vague, and in particular, memories of positive experiences can seem out of reach. This memory difficulty promotes posttraumatic stress disorder (PTSD). This study will explore an intervention that aims to improve memory difficulties, which should then flow on to improve PTSD. The study will be completed with individuals who have experienced a single incident trauma. Twenty five participants will complete MemFlex straight away, and 25 will go on a waiting list. Once this first group has finished MemFlex, the researchers will compare the two groups to see if the programme produced a larger reduction in PTSD symptoms. MemFlex is workbook-based, and as such, if it is successful it may offer an easy, cheap, and accessible way to offer psychological treatment to PTSD sufferers around the world.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind, randomized controlled trial comparing active intervention to waitlist control
Masking
Outcomes Assessor
Masking Description
Assessors will be blind to allocated condition
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Flexibility Training (MemFlex)
Arm Type
Experimental
Arm Description
The MemFlex programme has been adapted from the initial format addressing depression-related memory distortions to facilitate completion with individuals experiencing posttraumatic stress. The workbook and associated materials have also been translated from English to Farsi. The programme consists of one researcher-facilitated session and eight self-guided workbook-based sessions that train memory retrieval skills and are completed over a one month period.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
After randomisation, the waitlist control group will be informed that they have been placed on a waiting list for the intervention. The participants will complete the baseline assessment and receive no further contact from the researcher until the post assessment one month later, followed by the follow-up assessment three months later. After the three month assessment, wait listed participants will receive the intervention. No further assessments will be completed.
Intervention Type
Behavioral
Intervention Name(s)
Memory Flexibility training (MemFlex)
Intervention Description
MemFlex is a primarily self-guided, paper workbook-based program which aims to reduce overgeneral memory bias and improve recall of positive, specific event memories. Prior to completing one month of self-guided, workbook-based intervention, the participant will attend one 45 minute face-to-face session in which the facilitator outlines the importance of autobiographical memory in everyday life, discusses the impact of trauma on autobiographical memory, and provides information on the different types of autobiographical memories (e.g., specific, general) and their potential everyday functions. The session also introduces the cued-recall tasks which were used to train the memory skills throughout the workbook, and provides facilitator-assisted practice with the tasks. Once participants are comfortable with the training exercises, they set a schedule for completion of the eight-session workbook over the following four weeks.
Primary Outcome Measure Information:
Title
Autobiographical memory
Description
Number of correct responses on the Alternating Instructions Autobiographical Memory Test- Farsi version
Time Frame
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
Secondary Outcome Measure Information:
Title
PTSD symptoms at post-intervention
Description
Total score (range - 0-80) on the Farsi version of the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders- Fifth Edition
Time Frame
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
Title
PTSD symptoms at follow-up
Description
Total score (range - 0-80) on the Farsi version of the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders- Fifth Edition
Time Frame
Three months following the completion of the intervention
Other Pre-specified Outcome Measures:
Title
Posttraumatic Cognitions
Description
Total score (range = 33-231) on the Farsi version of the Posttraumatic Cognitions Inventory
Time Frame
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
Title
Trauma memory quality
Description
Total score (range = 14-56) on the Farsi version of the Trauma Memory Quality Questionnaire
Time Frame
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
Title
Rumination
Description
Total score (range = 22-88) on the Farsi version of the Ruminative Response Scale
Time Frame
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
Title
Depression
Description
Total score (range = 0-63) on the Farsi version of the Beck Depression Inventory II
Time Frame
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
Title
Future Thinking
Description
Number of generated positive items on the Farsi version of the Future Thinking Task
Time Frame
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)

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: Diagnosis of Posttraumatic Stress Disorder (as indexed by the Farsi version of the Structured Clinical Interview for DSM disorders [SCID]) Aged over 18 years Exclusion Criteria: Lack of oral and/or written fluency in Farsi Traumatic brain injury or cognitive impairment, indexed via self-report Current experience of psychosis, indexed by SCID
Facility Information:
Facility Name
Institute for Cognitive Science Studies
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified dataset will be made available online and linked to the published results
IPD Sharing Time Frame
At time of publication of peer-reviewed manuscript
IPD Sharing Access Criteria
Open access

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Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

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