Condition category
Mental and Behavioural Disorders
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
19/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ed Watkins

ORCID ID

Contact details

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

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

http://www.exeter.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: 72156)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes