Cognitive training as a facilitated self-help intervention for depression: a Medical Research Council (MRC) experimental medicine trial
| ISRCTN | ISRCTN39455344 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39455344 |
| Secondary identifying numbers | 4580 |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 19/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ed Watkins
Scientific
Scientific
Mood Disorders Centre
School of Psychology
Washington Singer Laboratories
Perry Road
Exeter
EX4 4QG
United Kingdom
Study information
| Study design | Randomised interventional single centre treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cognitive training as a facilitated self-help intervention for depression: a randomised interventional single centre treatment trial |
| Study objectives | 1. Can concreteness cognitive training facilitated self-help produce robust and stable shifts in thinking style in dysphoric and moderately depressed individuals, relative to a no training control condition (treatment-as-usual) and relative to an active intervention controlling for non-specific factors (relaxation)? 2. Can cognitive training facilitated self-help in addition to treatment-as-usual significantly reduce rumination and depression in depressed patients relative to treatment-as-usual and relative to an active intervention controlling for non-specific factors (relaxation) in a primary care setting? 3. Does the shift in thinking style causally mediate the effects of cognitive training on rumination and depression? To investigate mediation using Baron and Kenny's criteria, we will investigate a series of supplementary research questions: 3.1. Does treatment condition have a significant effect on outcome? 3.2. Does treatment condition influence changes in the given cognitive process from before to after therapy? 3.3. Does change in the given cognitive process predict outcome? 3.4. Does change in the given cognitive process remain a significant predictor of outcome when controlling for treatment condition 3.5. Is the effect of treatment condition on outcome attenuated when controlling for change in the given cognitive process? A given cognitive process could be said to function as a mediator of facilitated self-help on outcome if all the above questions are answered "yes". 4. Is cognitive training feasible and acceptable as a potential self-help intervention? 5. What patient factors might predict response to the psychological intervention? |
| Ethics approval(s) | Devon and Torbay REC approved in September 2006 (ref: 06/Q2102/66) |
| Health condition(s) or problem(s) studied | Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Depression, Not Assigned; Disease: Depression, All Diseases |
| Intervention | 1. Cognitive training self-help in addition to treatment-as-usual 2. Relaxation training self-help in addition to treatment-as-usual 3. Treatment-as-usual The cognitive training facilitated self-help intervention will consist of an initial meeting lasting approximately 1.5 hours (subject to modification as the project progresses), during which the researcher will explain the rationale for why cognitive training is helpful and then practice relaxation or the cognitive training paradigm. Follow Up Length: 6 month(s) Study Entry: Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | Hamilton Rating Scale for Depression - 17 item version (HRS-D). Timepoints were assessed at baseline pre-treatment, 2 months post-baseline assessment (post-treatment), after 3 months follow-up (i.e., after 5 months post-baseline) and after 6 months follow-up (i.e., 8 months post baseline assessment). |
| Secondary outcome measures | Depressive symptoms: the Beck Depression Inventory (BDI-II). Timepoints were assessed at baseline pre-treatment, 2 months post-baseline assessment (post-treatment), after 3 months follow-up (i.e., after 5 months post-baseline) and after 6 months follow-up (i.e., 8 months post baseline assessment). |
| Overall study start date | 01/03/2008 |
| Completion date | 31/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Key inclusion criteria | 1. Aged 18 years or older, either sex 2. Currently depressed patients, whether they are currently taking antidepressant medication or not |
| Key exclusion criteria | 1. Current co-morbid diagnosis or history of bipolar disorder, schizophrenia or other psychotic disorders 2. Current and clinically significant drug or alcohol dependence 3. Persistent anti-social behaviour 4. Persistent self-injury requiring clinical management/therapy 5. Learning disability (intelligence quotient [IQ] less than 70) 6. Organic brain damage 7. Current formal face-to-face psychotherapy/counselling (does not include computer-based cognitive behavioural therapy [CBT], psychoeducation, or bibliotherapy) 8. Unable to engage with facilitated self-help treatment for physical, practical or other reasons (e.g. unable to comprehend materials) |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 31/08/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mood Disorders Centre
Exeter
EX4 4QG
United Kingdom
EX4 4QG
United Kingdom
Sponsor information
University of Exeter (UK)
University/education
University/education
The Queen s Drive
Exeter
EX4 4QJ
England
United Kingdom
| Website | http://www.exeter.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) (ref: 72156)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2012 | Yes | No |
