Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634709
• Other study ID #: MemFlex for PTSD
• Status: Completed
• Phase: N/A
• Start date: August 19, 2018
• Est. completion date: May 11, 2020

Study information

• Verified date: April 2020
• Source: Medical Research Council Cognition and Brain Sciences Unit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Institute for Cognitive Science Studies	Tehran

Sponsors (3)

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

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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