Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4580
Study information
Scientific title
Cognitive training as a facilitated self-help intervention for depression: a randomised interventional single centre treatment trial
Acronym
Study hypothesis
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
Devon and Torbay REC approved in September 2006 (ref: 06/Q2102/66)
Study design
Randomised interventional single centre treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/03/2008
Overall trial end date
31/08/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years or older, either sex
2. Currently depressed patients, whether they are currently taking antidepressant medication or not
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Participant 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)
Recruitment start date
01/03/2008
Recruitment end date
31/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Mood Disorders Centre
Exeter
EX4 4QG
United Kingdom
Sponsor information
Organisation
University of Exeter (UK)
Sponsor details
The Queen s Drive
Exeter
EX4 4QJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: 72156)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22085757
Publication citations
-
Results
Watkins ER, Taylor RS, Byng R, Baeyens C, Read R, Pearson K, Watson L, Guided self-help concreteness training as an intervention for major depression in primary care: a Phase II randomized controlled trial., Psychol Med, 2012, 42, 7, 1359-1371, doi: 10.1017/S0033291711002480.