An interventional study of Memory Flexibility training (MemFlex) in Post Traumatic Stress Disorder, sponsored by Medical Research Council Cognition and Brain Sciences Unit. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-17.
Sponsored by Medical Research Council Cognition and Brain Sciences Unit · Not applicable, Interventional, and Treatment
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's enrollment of 40 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Medical Research Council Cognition and Brain Sciences Unit is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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)
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.
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.
Autobiographical memory
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)
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
Time frame: 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
Time frame: Three months following the completion of the intervention
Posttraumatic Cognitions
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)
Trauma memory quality
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)
Rumination
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)
Depression
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)
Future Thinking
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)
Plan to share: Yes — De-identified dataset will be made available online and linked to the published results
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: At time of publication of peer-reviewed manuscript
Access criteria: Open access
No publications or documents are linked to this record.
Ran from Aug 2018 to primary completion in Feb 2020, 17 months.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 17 months is below that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Medical Research Council Cognition and Brain Sciences Unit