Cognitive Behavioural Therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: a randomised controlled trial

Conditions

Depression Mental and Behavioural Disorders Depression

Wiles NJ, Thomas L, Turner N, Garfield K, Kounali D, Campbell J, Kessler D, Kuyken W, Lewis G, Morrison J, Williams C, Peters TJ, Hollinghurst S.

2016-01-0775 citations

10.1016/s2215-0366(15)00495-2

Clinical effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: the CoBalT randomised controlled trial

Nicola Wiles, Laura Thomas, Anna Abel, Maria Barnes, Fran Carroll et al. (23 authors)

Health Technology Assessment2014-05-01128 citations

10.3310/hta18310

Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial.

Wiles N, Thomas L, Abel A, Ridgway N, Turner N, Campbell J, Garland A, Hollinghurst S, Jerrom B, Kessler D, Kuyken W, Morrison J, Turner K, Williams C, Peters T, Lewis G.

2012-12-07215 citations

10.1016/s0140-6736(12)61552-9

Interventions

Patients will be randomised to one of two groups. All patients will be taking antidepressants at the point of randomisation. Both groups will continue their antidepressants as directed by their GP.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years 2. Patients currently taking antidepressant medication and who have done so for at least 6 weeks at an adequate dose 3. Patients who score 14 or more on the Beck Depression Inventory (BDI) 4. Have adhered to their medication 5. Meet the World Health Organization International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) criteria for depression

Exclusion criteria

Exclusion criteria: 1. Bipolar disorder 2. Psychosis or alcohol/substance abuse/dependence 3. Not able to complete the study questionnaires 4. Currently receiving CBT or other psychotherapy or secondary care for depression 5. Have received CBT in the past 3 years 6. Patients who would not be able to benefit from talking therapy without an interpreter 7. Women who are pregnant at time of recruitment will be excluded from the trial but women who become pregnant during the trial may continue, providing they have approval and permission to do so from their GP

Design outcomes

Primary

Measure	Time frame
BDI score at 6-months post-randomisation, specifically a binary variable representing response, defined as a reduction in depressive symptoms of at least 50% compared to baseline.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 19/02/2013: Remission of symptoms, quality of life and use of antidepressants at 6 months post-randomisation, together with outcomes measured at 12 months post-randomisation and long-term outcomes measured approximately 4 years post-randomisation. Previous secondary outcome measures until 19/02/2013: Remission of symptoms, quality of life and use of antidepressants at 6 months post-randomisation, together with outcomes measured at 12 months post-randomisation.	—

Measure

Time frame

Current secondary outcome measures as of 19/02/2013: Remission of symptoms, quality of life and use of antidepressants at 6 months post-randomisation, together with outcomes measured at 12 months post-randomisation and long-term outcomes measured approximately 4 years post-randomisation. Previous secondary outcome measures until 19/02/2013: Remission of symptoms, quality of life and use of antidepressants at 6 months post-randomisation, together with outcomes measured at 12 months post-randomisation.

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Countries

United Kingdom

Outcome results

None listed