Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: The CoBalT randomised controlled trial protocol

Thomas, Laura; Abel, Anna; Ridgway, Nicola; Peters, Tim J.; Keßler, David; Hollinghurst, Sandra; Turner, Katrina; Garland, Anne; Jerrom, Bill; Morrison, Jill; Williams, Chris; Campbell, John; Kuyken, Willem; Wiles, Nicola

doi:10.1016/j.cct.2011.10.016

Cited by 34 publications

(39 citation statements)

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“…CoBalT was a multi-centre pragmatic RCT with two parallel groups 14 . Ethical approval was given by the West Midlands Research Ethics Committee (NRES/07/H1208/60) and research governance approval was obtained from the local Primary Care Trusts/Health Boards.…”

Section: Methodsmentioning

confidence: 99%

“…A three-stage recruitment process was used 14 . The record search identified patients who had received repeated prescriptions for antidepressants.…”

Section: Recruitmentmentioning

confidence: 99%

“…The intervention was delivered by 11 part-time therapists in the three sites who were representative of those working within NHS psychological services 14 . Ten out of the 11 therapists were female, their mean age was 39.2 years (SD 8.1) and they had practised as a therapist for a mean of 9.7 years (range: newly qualified to 30 years).…”

Section: Interventionmentioning

confidence: 99%

“…Fidelity of the intervention to the CBT model was evaluated 14 for a random sample of recordings by three independent raters from the Oxford Cognitive Therapy Centre using the Cognitive Therapy Rating scale (CTS-R), a valid and reliable CBT rating scale 23 .…”

Section: Interventionmentioning

confidence: 99%

“…Participants were followed up 3, 6, 9 and 12 months after randomisation 14 . Wherever possible, to maximise retention, researchers met with the participant face-to-face at 6 months and 12 months.…”

Section: Follow-upmentioning

confidence: 99%

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

et al. 2013

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Section: Methodsmentioning

confidence: 99%

“…A three-stage recruitment process was used 14 . The record search identified patients who had received repeated prescriptions for antidepressants.…”

Section: Recruitmentmentioning

confidence: 99%

Section: Interventionmentioning

confidence: 99%

Section: Interventionmentioning

confidence: 99%

Section: Follow-upmentioning

confidence: 99%

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

et al. 2013

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Psychological therapies for treatment-resistant depression in adults

Ijaz

Davies

Williams

et al. 2018

Cochrane Database of Systematic Reviews

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Background Antidepressants are a first-line treatment for adults with moderate to severe major depression. However, many people prescribed antidepressants for depression don't respond fully to such medication, and little evidence is available to inform the most appropriate 'next step' treatment for such patients, who may be referred to as having treatment-resistant depression (TRD). National Institute for 1. Any psychological therapy versus antidepressant treatment alone, or another psychological therapy. 2. Any psychological therapy given in addition to antidepressant medication versus antidepressant treatment alone, or a psychological therapy alone. Primary outcomes required were change in depressive symptoms and number of dropouts from study or treatment (as a measure of acceptability). Data collection and analysis We extracted data, assessed risk of bias in duplicate, and resolved disagreements through discussion or consultation with a third person. We conducted random-effects meta-analyses when appropriate. We summarised continuous outcomes using mean differences (MDs) or standardised mean differences (SMDs), and dichotomous outcomes using risk ratios (RRs). Main results We included six trials (n = 698; most participants were women approximately 40 years of age). All studies evaluated psychotherapy plus usual care (with antidepressants) versus usual care (with antidepressants). Three studies addressed the addition of cognitivebehavioural therapy (CBT) to usual care (n = 522), and one each evaluated intensive short-term dynamic psychotherapy (ISTDP) (n = 60), interpersonal therapy (IPT) (n = 34), or group dialectical behavioural therapy (DBT) (n = 19) as the intervention. Most studies were small (except one trial of CBT was large), and all studies were at high risk of detection bias for the main outcome of self-reported depressive symptoms. A random-effects meta-analysis of five trials (n = 575) showed that psychotherapy given in addition to usual care (vs usual care alone) produced improvement in self-reported depressive symptoms (MD-4.07 points, 95% confidence interval (CI)-7.07 to-1.07 on the Beck Depression Inventory (BDI) scale) over the short term (up to six months). Effects were similar when data from all six studies were combined for self-reported depressive symptoms (SMD-0.40, 95% CI-0.65 to-0.14; n = 635). The quality of this evidence was moderate. Similar moderate-quality evidence of benefit was seen on the Patient Health Questionnaire-9 Scale (PHQ-9) from two studies (MD-4.66, 95% CI 8.72 to-0.59; n = 482) and on the Hamilton Depression Rating Scale (HAMD) from four studies (MD-3.28, 95% CI-5.71 to-0.85; n = 193). High-quality evidence shows no differential dropout (a measure of acceptability) between intervention and comparator groups over the short term (RR 0.85, 95% CI 0.58 to 1.24; six studies; n = 698). Moderate-quality evidence for remission from six studies (RR 1.92, 95% CI 1.46 to 2.52; n = 635) and low-quality evidence for response from four studies (RR 1.80, 95% CI 1.2 to 2.7; n = 556) i...

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Reference‐based multiple imputation for missing data sensitivity analyses in trial‐based cost‐effectiveness analysis

et al. 2019

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Missing data are a common issue in cost‐effectiveness analysis (CEA) alongside randomised trials and are often addressed assuming the data are ‘missing at random’. However, this assumption is often questionable, and sensitivity analyses are required to assess the implications of departures from missing at random. Reference‐based multiple imputation provides an attractive approach for conducting such sensitivity analyses, because missing data assumptions are framed in an intuitive way by making reference to other trial arms. For example, a plausible not at random mechanism in a placebo‐controlled trial would be to assume that participants in the experimental arm who dropped out stop taking their treatment and have similar outcomes to those in the placebo arm. Drawing on the increasing use of this approach in other areas, this paper aims to extend and illustrate the reference‐based multiple imputation approach in CEA. It introduces the principles of reference‐based imputation and proposes an extension to the CEA context. The method is illustrated in the CEA of the CoBalT trial evaluating cognitive behavioural therapy for treatment‐resistant depression. Stata code is provided. We find that reference‐based multiple imputation provides a relevant and accessible framework for assessing the robustness of CEA conclusions to different missing data assumptions.

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Cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: The CoBalT randomised controlled trial protocol

Cited by 34 publications

References 34 publications

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

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

Psychological therapies for treatment-resistant depression in adults

Reference‐based multiple imputation for missing data sensitivity analyses in trial‐based cost‐effectiveness analysis

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