Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

Sponsor

Medical Research Council Cognition and Brain Sciences Unit (Other)

Overall Status

Completed

CT.gov ID

NCT03634709

Collaborator

Institute for Cognitive Science Studies, Iran (Other), Kharazmi University (Other)

Enrollment

Location

Arms

20.7

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Behavioral: Memory Flexibility training (MemFlex)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single blind, randomized controlled trial comparing active intervention to waitlist controlSingle blind, randomized controlled trial comparing active intervention to waitlist control

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessors will be blind to allocated condition

Primary Purpose:

Treatment

Official Title:

A Randomised Controlled Trial of Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

Actual Study Start Date :

Aug 19, 2018

Actual Primary Completion Date :

Feb 11, 2020

Actual Study Completion Date :

May 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Memory Flexibility Training (MemFlex) 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.	Behavioral: Memory Flexibility training (MemFlex) 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.
No Intervention: Waitlist control 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.

Arm

Intervention/Treatment

Experimental: Memory Flexibility Training (MemFlex)

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.

Behavioral: Memory Flexibility training (MemFlex)

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.

No Intervention: Waitlist control

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.

Outcome Measures

Primary Outcome Measures

Autobiographical memory [At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)]
Number of correct responses on the Alternating Instructions Autobiographical Memory Test- Farsi version

Secondary Outcome Measures

PTSD symptoms at post-intervention [At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)]
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 [Three months following the completion of the 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

Other Outcome Measures

Posttraumatic Cognitions [At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)]
Total score (range = 33-231) on the Farsi version of the Posttraumatic Cognitions Inventory
Trauma memory quality [At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)]
Total score (range = 14-56) on the Farsi version of the Trauma Memory Quality Questionnaire
Rumination [At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)]
Total score (range = 22-88) on the Farsi version of the Ruminative Response Scale
Depression [At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)]
Total score (range = 0-63) on the Farsi version of the Beck Depression Inventory II
Future Thinking [At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)]
Number of generated positive items on the Farsi version of the Future Thinking Task

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for Cognitive Science Studies	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Medical Research Council Cognition and Brain Sciences Unit
Institute for Cognitive Science Studies, Iran
Kharazmi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Caitlin Hitchcock, Senior Scientist, Medical Research Council Cognition and Brain Sciences Unit

ClinicalTrials.gov Identifier:

NCT03634709

Other Study ID Numbers:

MemFlex for PTSD

First Posted:

Aug 16, 2018

Last Update Posted:

Jun 17, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jun 17, 2020