Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Memory Flexibility training (MemFlex)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Institute for Cognitive Science Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autobiographical memory	Number of correct responses on the Alternating Instructions Autobiographical Memory Test- Farsi version	At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
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	Three months following the completion of the intervention

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical Research Council Cognition and Brain Sciences Unit
• Collaborators: Institute for Cognitive Science Studies, Iran; Kharazmi University

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2018
• Primary Completion (Actual): February 11, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MemFlex for PTSD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No