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
Protocol serial number	4580
Sponsor	University of Exeter (UK)
Funder	Medical Research Council (MRC) (UK) (ref: 72156)

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

Mood Disorders Centre
School of Psychology
Washington Singer Laboratories
Perry Road
Exeter
EX4 4QG
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional single centre treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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).
Key secondary outcome measure(s)	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).
Completion date	31/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Mood Disorders Centre

Exeter
EX4 4QG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes