Background:

Depression is a common, debilitating and costly disorder. The best-evidenced psychological therapy – cognitive–behavioural therapy (CBT) – is complex and costly. A simpler therapy, behavioural activation (BA), may be an effective alternative.

Objectives:

To determine the clinical effectiveness and cost-effectiveness of BA compared with CBT for depressed adults at 12 and 18 months’ follow-up, and to investigate the processes of treatments.

Design:

Randomised controlled, non-inferiority trial stratified by depression severity, antidepressant use and recruitment site, with embedded process evaluation; and randomisation by remote computer-generated allocation.

Setting:

Three community mental health services in England.

Participants:

Adults aged ≥ 18 years with major depressive disorder (MDD) recruited from primary care and psychological therapy services.

Interventions:

BA delivered by NHS junior mental health workers (MHWs); CBT by NHS psychological therapists.

Outcomes:

Primary: depression severity (as measured via the Patient Health Questionnaire-9; PHQ-9) at 12 months. Secondary: MDD status; number of depression-free days; anxiety (as measured via the Generalised Anxiety Disorder-7); health-related quality of life (as measured via the Short Form questionnaire-36 items) at 6, 12 and 18 months; and PHQ-9 at 6 and 18 months, all collected by assessors blinded to treatment allocation. Non-inferiority margin was 1.9 PHQ-9 points. We undertook intention-to-treat (ITT) and per protocol (PP) analyses. We explored cost-effectiveness by collecting direct treatment and other health- and social-care costs and calculating quality-adjusted life-years (QALYs) using the EuroQol-5 Dimensions, three-level version, at 18 months.

Results:

We recruited 440 participants (BA, n = 221; CBT, n = 219); 175 (79%) BA and 189 (86%) CBT participants provided ITT data and 135 (61%) BA and 151 (69%) CBT participants provided PP data. At 12 months we found that BA was non-inferior to CBT {ITT: CBT 8.4 PHQ-9 points [standard deviation (SD) 7.5 PHQ-9 points], BA 8.4 PHQ-9 points (SD 7.0 PHQ-9 points), mean difference 0.1 PHQ-9 points, 95% confidence interval (CI) –1.3 to 1.5 PHQ-9 points, p = 0.89; PP: CBT 7.9 PHQ-9 points (SD 7.3 PHQ-9 points), BA 7.8 PHQ-9 points (SD 6.5 PHQ-9 points), mean difference 0.0 PHQ-9 points, 95% CI –1.5 to 1.6 PHQ-9 points, p = 0.99}. We found no differences in secondary outcomes. We found a significant difference in mean intervention costs (BA, £975; CBT, £1235; p < 0.001), but no differences in non-intervention (hospital, community health, social care and medication costs) or total (non-intervention plus intervention) costs. Costs were lower and QALY outcomes better in the BA group, generating an incremental cost-effectiveness ratio of –£6865. The probability of BA being cost-effective compared with CBT was almost 80% at the National Institute for Health and Care Excellence’s preferred willingness-to-pay threshold of £20,000–30,000 per QALY. There were no trial-related adverse events.

Limitations:

In this pragmatic trial many depressed participants in both groups were also taking antidepressant medication, although most had been doing so for a considerable time before entering the trial. Around one-third of participants chose not to complete a PP dose of treatment, a finding common in both psychotherapy trials and routine practice.

Conclusions:

We found that BA is as effective as CBT, more cost-effective and can be delivered by MHWs with no professional training in psychological therapies.

Future work:

Settings and countries with a paucity of professionally qualified psychological therapists, might choose to investigate the delivery of effective psychological therapy for depression without the need to develop an extensive and costly professional infrastructure.

Trial registration:

Current Controlled Trials ISRCTN27473954.

Funding:

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 46. See the NIHR Journals Library website for further project information.

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 10/50/14. The contractual start date was in April 2012. The draft report began editorial review in October 2016 and was accepted for publication in March 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

All authors report grants from the National Institute for Health Research (NIHR) during the course of the study. David A Richards reports grants from the European Science Foundation. David A Richards and Rod S Taylor have received funding support from NIHR Collaborations for Leadership in Applied Health Research and Care. David A Richards reports NIHR Clinical Development and Senior Clinical Fellowship and Senior Investigator Panel memberships. Rod S Taylor reports membership of NIHR Health Technology Assessment (HTA) programme themed call, NIHR HTA Efficient Study Designs Board and NIHR Health Services and Delivery Research Commissioning Boards. Simon Gilbody reports membership of the NIHR HTA Evidence Synthesis Board and NIHR HTA Efficient Study Designs Board. Willem Kuyken reports fees from Guilford Press for book royalties and Collaborative Case Conceptualisation.

Disclaimer

This report contains transcripts of interviews conducted in the course of the research and contains language that may offend some readers.