Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

NCT03634709 | Completed

• 1 other identifier: MemFlex for PTSD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PTSD symptoms at post-intervention

  At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)

• PTSD symptoms at follow-up

  Three months following the completion of the intervention

Other Outcomes (5)

• Posttraumatic Cognitions

  At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)

• Trauma memory quality

  At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)

• Rumination

  At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)

Study Arms (2)

Memory Flexibility Training (MemFlex)

EXPERIMENTAL

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)

Waitlist control

NO INTERVENTION

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.

Interventions

Memory Flexibility training (MemFlex) BEHAVIORAL

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.

Memory Flexibility Training (MemFlex)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institute for Cognitive Science Studies

Tehran, Iran

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to allocated condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: Single blind, randomized controlled trial comparing active intervention to waitlist control

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: August 16, 2018
• Study Start: August 19, 2018
• Primary Completion: February 11, 2020
• Study Completion: May 11, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At time of publication of peer-reviewed manuscript
• Access Criteria: Open access

Locations

IR (1)