Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

June 16, 2020 updated by: Caitlin Hitchcock, Medical Research Council Cognition and Brain Sciences Unit

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
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
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
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
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
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
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)
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
At post-intervention assessment (approximately 4-5 weeks after pre-intervention assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical Research Council Cognition and Brain Sciences Unit

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institute for Cognitive Science Studies, Iran
Kharazmi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MemFlex for PTSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified dataset will be made available online and linked to the published results

IPD Sharing Time Frame

At time of publication of peer-reviewed manuscript

IPD Sharing Access Criteria

Open access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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