Post Traumatic Stress DisorderNCT03634709
Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder
A study testing Memory Flexibility training (MemFlex) in people with Post Traumatic Stress Disorder, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Memory Flexibility training (MemFlex)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 19 Aug 2018to 11 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Posttraumatic Stress Disorder (as indexed by the Farsi version of the Structured Clinical Interview for DSM disorders [SCID])
- Aged over 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Memory Flexibility training (MemFlex)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Flexibility training (MemFlex)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autobiographical memory
Number of correct responses on the Alternating Instructions Autobiographical Memory Test- Farsi version
Measured: At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
Secondary outcomes (2)
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
Measured: 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
Measured: Three months following the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start19 Aug 2018
- Primary completion11 Feb 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind, randomized controlled trial comparing active intervention to waitlist control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council Cognition and Brain Sciences Unit
- Sponsor type
- Other government
- Collaborators
- Institute for Cognitive Science Studies, Iran, Kharazmi University
- Responsible party
- Principal investigator, Caitlin Hitchcock, Medical Research Council Cognition and Brain Sciences Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634709
- Sponsor's protocol ID
- MemFlex for PTSD
- Status last verified
- Apr 2020
- First submitted
- 23 Feb 2018
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified dataset will be made available online and linked to the published results
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03634709
- Acronym / sponsor ID
- MemFlex for PTSD
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical Research Council Cognition and Brain Sciences UnitOther government
- Collaborators
- Institute for Cognitive Science Studies, Iran, Kharazmi University
- Study start
- 19 Aug 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blind, randomized controlled trial comparing active intervention to waitlist control
| Arm | Type | Receives |
|---|---|---|
| Memory Flexibility Training (MemFlex) | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Posttraumatic Stress Disorder (as indexed by the Farsi version of the Structured Clinical Interview for DSM disorders [SCID])
- Aged over 18 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Memory Flexibility Training (MemFlex) |
Primary outcome
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
2 secondary outcomes
PTSD symptoms at post-intervention
Time frame: At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
PTSD symptoms at follow-up
Time frame: Three months following the completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: Yes. De-identified dataset will be made available online and linked to the published results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Flexibility training (MemFlex) in people with Post Traumatic Stress Disorder, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autobiographical memory (time frame: At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.