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Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT03634709
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
Institute for Cognitive Science Studies, Iran
Kharazmi University
Information provided by (Responsible Party):
Caitlin Hitchcock, Medical Research Council Cognition and Brain Sciences Unit

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single 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 : August 19, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Autobiographical memory [ Time Frame: 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 :
  1. PTSD symptoms at post-intervention [ Time Frame: 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

  2. PTSD symptoms at follow-up [ Time Frame: 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:
  1. Posttraumatic Cognitions [ Time Frame: 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

  2. Trauma memory quality [ Time Frame: 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

  3. Rumination [ Time Frame: 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

  4. Depression [ Time Frame: 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

  5. Future Thinking [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634709


Contacts
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Contact: Caitlin Hitchcock +44 1223 273 744 caitlin.hitchcock@mrc-cbu.cam.ac.uk
Contact: Ali Reza Moradi Moradi@khu.ac.ir

Locations
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Iran, Islamic Republic of
Institute for Cognitive Science Studies Recruiting
Tehran, Iran, Islamic Republic of
Contact: Maryam Piltan       maryam.piltan@Modares.ac.ir   
Sponsors and Collaborators
Medical Research Council Cognition and Brain Sciences Unit
Institute for Cognitive Science Studies, Iran
Kharazmi University

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Responsible Party: Caitlin Hitchcock, Senior Scientist, Medical Research Council Cognition and Brain Sciences Unit
ClinicalTrials.gov Identifier: NCT03634709     History of Changes
Other Study ID Numbers: MemFlex for PTSD
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified dataset will be made available online and linked to the published results
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: At time of publication of peer-reviewed manuscript
Access Criteria: Open access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders