Major Depressive DisorderPhase 1/2NCT02371291
Memory Flexibility Training for Depression
A Phase 1/2 study testing Memory Flexibility Training and Psychoeducation in people with Major Depressive Disorder, run by Medical Research Council Cognition and Brain Sciences Unit at 2 sites in United Kingdom.
Trial summary
Our collection of memories for personal experiences plays an important role in shaping our sense of who we are as people. These memories, termed autobiographical memories, can also be helpful in social situations, for sharing the details of our experiences with other people, reminiscing about pleasant times and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Memory Flexibility Training and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2015to Jan 2017
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently experiencing Major Depressive Episode, indexed on the Structured Clinical Interview for the DSM-IV (SCID; First et al., 1996).
- Score of 13 or above on the Beck Depression Inventory (Beck et al., 1996)
Who cannot join
- SCID assessment indicates they are experiencing another mood disorder, psychosis, current alcohol or substance dependence/abuse.
- Diagnosed Axis II disorder or brain injury (assessed by participant report)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
MRC Cognition and Brain Sciences Unit
Cambridge, CB2 7EF
Cambridge and Peterborough NHS Foundation Trust
Cambridge
About this study
Official title: A Randomized Controlled Trial Comparing Memory Flexibility Training to Psychoeducation in the Treatment of Major Depressive Disorder
Our collection of memories for personal experiences plays an important role in shaping our sense of who we are as people. These memories, termed autobiographical memories, can also be helpful in social situations, for sharing the details of our experiences with other people, reminiscing about pleasant times and solving problems by remembering what has and hasn't worked in the past. Different types of autobiographical memory are helpful to us depending on the particular situation the investigators are in at the time. Recent research has shown that experiencing depressed mood can affect how we relate to our autobiographical memories, so that instead of providing a rich source of personal information in a helpful and flexible way, the types of memories that come to mind are more narrowly focused on difficult or negative experiences. This can cause low mood to persist over time.
The purpose of this study is to test a newly-developed therapeutic training package for depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to autobiographical memories. The MemFlex programme consists of a one-to-one orientation session with the researcher to introduce the training package, followed by a workbook that is completed at home.
- Conditions
- Major Depressive Disorder
- Being tested
- Memory Flexibility Training, Psychoeducation
- Keywords
- Memory Flexibility
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Flexibility TrainingBehavioural
As in experimental arm description.
PsychoeducationBehavioural
As in experimental arm description.
| Study group | Role | What they receive |
|---|---|---|
| Memory Flexibility Training | Experimental | The MemFlex programme draws on cognitive bias modification and memory specificity training techniques (Raes et al., 2009; Dalgleish et al., 2014), and was developed by clinical psychologists. MemFlex is primarily self-guided and aims to reduce autobiographical memory biases associated with depression. The training material is presented over one face-to-face session and eight self-guided sessions. In the initial session, the researcher introduces cued-recall tasks which are used throughout the workbook, and guides the participant in completion of these tasks. When understanding of the basic principles is satisfactory, the researcher assists the participant to set a schedule for completion of the workbook over the following four weeks. The participant will receive weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress. Receives: Behavioral: Memory Flexibility Training |
| Psychoeducation | Placebo comparator | The psychoeducation condition will also complete an initial face-to-face session. This session will cover the symptoms and causes of depression, and the workbook will be introduced. As in the MemFlex condition, the workbook will consist of eight self-guided sessions that the individual will be required to complete over four weeks. The participant will receive weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress, and clarify any difficulties with the workbook material. The workbook content will cover the presentation of depression and basic information on factors associated with depression, such as worry, procrastination, and sleep difficulties. Each session consists of information on psychological theories of the topic, followed by a series of questions about the material to ensure participant engagement. The workbook was developed by clinical psychologists. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Status
Measured: Three months after completion of the workbook
Change in score on the Beck Depression Inventory (Beck, Steer, & Brown, 1996) from baseline
Self report measure of depression symptoms
Measured: Three months after completion of the workbook
Secondary outcomes (2)
Depression free days
Number of depression free days from post to follow-up.
Measured: Three months after completion of the workbook
Change in memory flexibility from baseline, Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Measured: Three months after completion of the workbook
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Major Depressive 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council Cognition and Brain Sciences Unit
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tim Dalgleish, PhD, Principal investigator, MRC Cognition and Brain Sciences Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371291
- Sponsor's protocol ID
- Mrccbu
- Status last verified
- Sep 2017
- First submitted
- 9 Feb 2015
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Raes F, Williams JM, Hermans D. Reducing cognitive vulnerability to depression: a preliminary investigation of MEmory Specificity Training (MEST) in inpatients with depressive symptomatology. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):24-38. doi: 10.1016/j.jbtep.2008.03.001. Epub 2008 Mar 12.
PubMed 18407245Dalgleish T, Bevan A, McKinnon A, Breakwell L, Mueller V, Chadwick I, Schweizer S, Hitchcock C, Watson P, Raes F, Jobson L, Werner-Seidler A. A comparison of MEmory Specificity Training (MEST) to education and support (ES) in the treatment of recurrent depression: study protocol for a cluster randomised controlled trial. Trials. 2014 Jul 22;15:293. doi: 10.1186/1745-6215-15-293.
PubMed 25052061Beck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
First, M., Spitzer, R., Gibbons, M., & Williams, J. (1996). Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-IV). Washington, DC: American Psychiatric Press.
Hitchcock C, Gormley S, Rees C, Rodrigues E, Gillard J, Panesar I, Wright IM, Hammond E, Watson P, Werner-Seidler A, Dalgleish T. A randomised controlled trial of memory flexibility training (MemFlex) to enhance memory flexibility and reduce depressive symptomatology in individuals with major depressive disorder. Behav Res Ther. 2018 Nov;110:22-30. doi: 10.1016/j.brat.2018.08.008. Epub 2018 Aug 29.
PubMed 30199738Hitchcock C, Hammond E, Rees C, Panesar I, Watson P, Werner-Seidler A, Dalgleish T. Memory Flexibility training (MemFlex) to reduce depressive symptomatology in individuals with major depressive disorder: study protocol for a randomised controlled trial. Trials. 2015 Nov 3;16:494. doi: 10.1186/s13063-015-1029-y.
PubMed 26531124
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Memory Flexibility Training to Psychoeducation in the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02371291
- Acronym / sponsor ID
- Mrccbu
- Conditions
- Major Depressive Disorder
- Keywords
- Memory Flexibility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical Research Council Cognition and Brain Sciences UnitOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Feb 2015 (estimated)
- 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.
Our collection of memories for personal experiences plays an important role in shaping our sense of who we are as people. These memories, termed autobiographical memories, can also be helpful in social situations, for sharing the details of our experiences with other people, reminiscing about pleasant times and solving problems by remembering what has and hasn't worked in the past. Different types of autobiographical memory are helpful to us depending on the particular situation the investigators are in at the time. Recent research has shown that experiencing depressed mood can affect how we relate to our autobiographical memories, so that instead of providing a rich source of personal information in a helpful and flexible way, the types of memories that come to mind are more narrowly focused on difficult or negative experiences. This can cause low mood to persist over time.
The purpose of this study is to test a newly-developed therapeutic training package for depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to autobiographical memories. The MemFlex programme consists of a one-to-one orientation session with the researcher to introduce the training package, followed by a workbook that is completed at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory Flexibility Training | Experimental | Behavioral: Memory Flexibility TrainingThe MemFlex programme draws on cognitive bias modification and memory specificity training techniques (Raes et al., 2009; Dalgleish et al., 2014), and was developed by clinical psychologists. MemFlex is primarily self-guided and aims to reduce autobiographical memory biases associated with depression. The training material is presented over one face-to-face session and eight self-guided sessions. In the initial session, the researcher introduces cued-recall tasks which are used throughout the workbook, and guides the participant in completion of these tasks. When understanding of the basic principles is satisfactory, the researcher assists the participant to set a schedule for completion of the workbook over the following four weeks. The participant will receive weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress. |
| Psychoeducation | Placebo comparator | Behavioral: PsychoeducationThe psychoeducation condition will also complete an initial face-to-face session. This session will cover the symptoms and causes of depression, and the workbook will be introduced. As in the MemFlex condition, the workbook will consist of eight self-guided sessions that the individual will be required to complete over four weeks. The participant will receive weekly emails during this period, encouraging them to complete the workbook. They will also receive a phone call from a team member at the beginning of week three to check progress, and clarify any difficulties with the workbook material. The workbook content will cover the presentation of depression and basic information on factors associated with depression, such as worry, procrastination, and sleep difficulties. Each session consists of information on psychological theories of the topic, followed by a series of questions about the material to ensure participant engagement. The workbook was developed by clinical psychologists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently experiencing Major Depressive Episode, indexed on the Structured Clinical Interview for the DSM-IV (SCID; First et al., 1996).
- Score of 13 or above on the Beck Depression Inventory (Beck et al., 1996)
Key exclusion criteria (2 listed)
- SCID assessment indicates they are experiencing another mood disorder, psychosis, current alcohol or substance dependence/abuse.
- Diagnosed Axis II disorder or brain injury (assessed by participant report)
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 TrainingAs in experimental arm description. | Behavioural | Memory Flexibility Training |
| PsychoeducationAs in experimental arm description. | Behavioural | Psychoeducation |
Primary outcome
Depressive Status
Time frame: Three months after completion of the workbook
Change in score on the Beck Depression Inventory (Beck, Steer, & Brown, 1996) from baseline
Time frame: Three months after completion of the workbook
Self report measure of depression symptoms
2 secondary outcomes
Depression free days
Time frame: Three months after completion of the workbook
Change in memory flexibility from baseline, Score on the alternating instructions autobiographical memory task (Dritschel et al., 2013)
Time frame: Three months after completion of the workbook
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 11 Sep 2017.
- Background: PubMed 18407245Raes F, Williams JM, Hermans D. Reducing cognitive vulnerability to depression: a preliminary investigation of MEmory Specificity Training (MEST) in inpatients with depressive symptomatology. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):24-38. doi: 10.1016/j.jbtep.2008.03.001. Epub 2008 Mar 12.
- Background: PubMed 25052061Dalgleish T, Bevan A, McKinnon A, Breakwell L, Mueller V, Chadwick I, Schweizer S, Hitchcock C, Watson P, Raes F, Jobson L, Werner-Seidler A. A comparison of MEmory Specificity Training (MEST) to education and support (ES) in the treatment of recurrent depression: study protocol for a cluster randomised controlled trial. Trials. 2014 Jul 22;15:293. doi: 10.1186/1745-6215-15-293.
- BackgroundBeck, A., Steer, R., & Brown, G. (1996). Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation.
- BackgroundFirst, M., Spitzer, R., Gibbons, M., & Williams, J. (1996). Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-IV). Washington, DC: American Psychiatric Press.
- Derived from this study: PubMed 30199738Hitchcock C, Gormley S, Rees C, Rodrigues E, Gillard J, Panesar I, Wright IM, Hammond E, Watson P, Werner-Seidler A, Dalgleish T. A randomised controlled trial of memory flexibility training (MemFlex) to enhance memory flexibility and reduce depressive symptomatology in individuals with major depressive disorder. Behav Res Ther. 2018 Nov;110:22-30. doi: 10.1016/j.brat.2018.08.008. Epub 2018 Aug 29.
- Derived from this study: PubMed 26531124Hitchcock C, Hammond E, Rees C, Panesar I, Watson P, Werner-Seidler A, Dalgleish T. Memory Flexibility training (MemFlex) to reduce depressive symptomatology in individuals with major depressive disorder: study protocol for a randomised controlled trial. Trials. 2015 Nov 3;16:494. doi: 10.1186/s13063-015-1029-y.
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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.
Tim Dalgleish, PhD principal investigator
MRC Cognition and Brain Sciences Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Memory Flexibility Training and Psychoeducation in people with Major Depressive Disorder, run by Medical Research Council Cognition and Brain Sciences Unit at 2 sites in United Kingdom.
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 2 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depressive Status (time frame: Three months after completion of the workbook). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371291, which also lists 6 linked publications.
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 11 Sep 2017.