Anna Abel

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

BACKGROUND Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. METHODS This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. FINDINGS Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). INTERPRETATION Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. FUNDING National Institute for Health Research Health Technology Assessment.

Cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: economic evaluation of the CoBalT Trial

BACKGROUND Depression is expensive to treat, but providing ineffective treatment is more expensive. Such is the case for many patients who do not respond to antidepressant medication. AIMS To assess the cost-effectiveness of cognitive-behavioural therapy (CBT) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone. METHOD Economic evaluation at 12 months alongside a randomised controlled trial. Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider, patients and society, with a range of outcomes. Cost-utility analysis comparing health and social care costs with quality-adjusted life-years (QALYs). RESULTS The mean cost of CBT per participant was £910. The difference in QALY gain between the groups was 0.057, equivalent to 21 days a year of good health. The incremental cost-effectiveness ratio was £14 911 (representing a 74% probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of £20 000 per QALY). Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups. CONCLUSIONS The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants. Primary care physicians should therefore be encouraged to refer such individuals for CBT.

Sudden gains in cognitive-behavior therapy for treatment-resistant depression: Processes of change.

OBJECTIVE Sudden gains were investigated in cognitive-behavioral therapy (CBT) for treatment-resistant depression (TRD). Client and therapist processes in sessions proximal to sudden gains were examined to better understand the antecedents of sudden gains and potential mechanisms linking them to outcome. METHOD Participants were 156 adults with TRD in a randomized controlled trial of CBT as an adjunct to pharmacotherapy (Wiles et al., 2013). Depression symptoms were assessed by the Beck Depression Inventory-II at each session. In a subsample of 50 clients, audio-recordings of 125 therapy sessions were rated for hope, emotional processing, and therapist competence in case-conceptualization. RESULTS Sudden gains were experienced by 54% of participants. Those with gains reported significantly lower depression severity at 12-month follow-up and more remission of symptoms than those without gains. Sudden gains also predicted lower depression at follow-up, beyond the slope of linear change in symptoms across treatment. Therapists demonstrated greater competence in case conceptualization with clients who reported sudden gains, and those with gains expressed more hope in sessions prior to a gain. In addition, more hope and emotional processing in the pregain sessions predicted less depression at follow-up, controlling for depression scores in the prior session. Better therapist conceptualization skills and more client hope in the baseline and pregain sessions were also associated with more emotional processing in those same sessions. CONCLUSION This study extends the phenomenon of sudden gains in CBT for depression to a treatment-resistant population and identified important therapy processes that predicted long-term outcomes: hope and emotional processing. (PsycINFO Database Record

Cost-effectiveness of CBT as an adjunct to pharmacotherapy for treatment resistant depression in primary care: economic evaluation of the CoBaIT Trial

BACKGROUND Depression is expensive to treat, but providing ineffective treatment is more expensive. Such is the case for many patients who do not respond to antidepressant medication. AIMS To assess the cost-effectiveness of cognitive-behavioural therapy (CBT) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone. METHOD Economic evaluation at 12 months alongside a randomised controlled trial. Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider, patients and society, with a range of outcomes. Cost-utility analysis comparing health and social care costs with quality-adjusted life-years (QALYs). RESULTS The mean cost of CBT per participant was £910. The difference in QALY gain between the groups was 0.057, equivalent to 21 days a year of good health. The incremental cost-effectiveness ratio was £14 911 (representing a 74% probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of £20 000 per QALY). Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups. CONCLUSIONS The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants. Primary care physicians should therefore be encouraged to refer such individuals for CBT.