Lifestyle therapy versus cognitive behavioural therapy for adults with mood disorders: a randomised non-inferiority trial

  1. Adrienne O’Neil
  2. Karyn Richardson
  3. Jessica A Davis
  4. Tayla John
  5. Sophie Mahoney
  6. Marita Bryan
  7. Rachel Fiddes
  8. Denny Meyer
  9. Dean Saunders
  10. Mary Lou Chatterton
  11. Megan Turner
  12. Sally Brown
  13. Felice N Jacka
  14. Niamh L Mundell
  15. Marlene Gojanovic
  16. Lara K Radovic
  17. Eileen McDonald
  18. Madeleine L. Connolly
  19. Greg Murray
  20. Neil Thomas
  21. Sanna Barrand
  22. Melissa O’Shea
  23. Tetyana Rocks
  24. Elena S. George
  25. Wolfgang Marx
  26. Md Parvez Mosharaf
  27. Tabinda Jabeen
  28. Anu Ruusunen
  29. Ravi Iyer
  30. Cathrine Mihalopoulos
  31. Michael Berk
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Abstract

Objective

To determine whether a multicomponent lifestyle intervention delivered by accredited dietitians and exercise physiologists was non-inferior to cognitive behavioural therapy (CBT) for reducing depressive symptoms in adults with moderate-to-severe mood disorders.

Design

Randomised, parallel-group, single-blind, non-inferiority trial.

Setting

Community-based recruitment across Australia with interventions delivered via telehealth.

Participants

358 adults with major depressive disorder or bipolar depression and moderate-to-severe depressive symptoms.

Interventions

Lifestyle therapy versus brief structured CBT.

Main outcome measures

Blinded interviewer-rated MADRS at 8 weeks with a prespecified non-inferiority margin of −1.6 points.

Results

Mean session attendance was 5.11/7 in the lifestyle therapy group and 5.40/7 in the CBT group; 91% of participants attended the initial individual session, and primary outcome data were available for 267 participants (130 lifestyle therapy; 137 CBT). Non-inferiority was supported at 8 weeks in both the intention-to-treat (β=1.76, 95% CI −0.28 to 3.81) and per-protocol (β=1.58, 95% CI −0.56 to 3.73) analyses. Depressive symptoms decreased in both groups. Mean MADRS scores decreased by 8.55 points (95% CI 7.09 to 10.02) with lifestyle therapy and 6.82 points (5.38 to 8.25) with CBT in the intention-to-treat analysis, with similar findings in the per-protocol analysis (8.37 points [6.84 to 9.90] and 6.79 points [5.27 to 8.31], respectively).

Conclusions

Lifestyle therapy was non-inferior to CBT and may expand access to evidence-based depression care through a broader allied health workforce.

Trial Registration

Australian New Zealand Clinical Trials Registry (Registry number: ACTRN12622001026718) https://www.anzctr.org.au/

What is already known on this topic

  • Lifestyle interventions are recommended in international clinical guidelines for adults with mood disorders.

  • Most previous randomised trials have compared lifestyle interventions with usual care or inactive controls rather than established psychological treatments.

  • Whether lifestyle therapy achieves clinical outcomes comparable to cognitive behavioural therapy (CBT) is uncertain.

What this study adds

  • In this randomised non-inferiority trial, lifestyle therapy delivered by accredited dietitians and exercise physiologists was non-inferior to a brief structured CBT programme for reducing depressive symptoms in adults with moderate-to-severe mood disorders.

  • Lifestyle therapy also improved several health behaviours, including diet quality, sleep, and alcohol and substance use risk.

  • Appropriately trained dietitians and exercise physiologists can deliver a first-line depression treatment producing outcomes comparable with psychologist-delivered CBT.

Article activity feed

  1. Version published to 10.64898/2026.09.08.26362466 on medRxiv