Initial evaluation of the Optimal Health Program for people with diabetes: 12-month outcomes of a randomised controlled trial

Abstract

Objective

This study aimed to evaluate if a new Mental health IN DiabeteS Optimal Health Program (MINDS OHP) compared with usual care in adults with Type 1 and Type 2 diabetes would improve psychosocial outcomes including self-efficacy and quality of life.

Design and Main Outcome Measures This initial randomised controlled trial evaluated MINDS OHP compared with usual care. Participants were recruited through outpatient clinics and community organisations. The intervention group received nine sessions with assessments over twelve months. Primary outcomes were self-efficacy and quality of life. Secondary outcomes included diabetes distress and anxiety.

Results

There were 51 participants in the control group (mean age = 52) and 55 in the intervention group (mean age = 55). There were significant main effects of time in general self-efficacy, diabetes distress, diabetes self-efficacy, and illness perceptions, however no significant between-group differences in primary or secondary outcomes. Post-hoc analyses revealed MINDS OHP improved diabetes self-efficacy for participants with mild to severe depression and anxiety, with a small effect.

Conclusion

Initial evaluation found MINDS OHP was associated with improved diabetes self-efficacy for adults with diabetes, for people with mild to severe levels of distress, with small effect. Further research is required to explore whether this disease-specific, collaborative care-focused intervention benefits the mental health of people with diabetes.

Keywords:

• Diabetes
• self-efficacy
• psychosocial
• educational
• mental health
• randomised controlled trial

Acknowledgements

We extend appreciation to community organisations (Diabetes Australia – Victoria and HypoActive) for assistance with study advertisements. We thank the clinicians at St. Vincent’s Hospital and the Royal Victorian Eye and Ear Hospital for referring participants to this research trial. We thank participants and MINDS OHP facilitators for their involvement in this trial.

Author contributions

DJC, CFS and DRT conceived the study. DJC developed the original OHP. DJC, CFS, DRT, GM, SK, and CLO designed the study. CFS and DJC wrote the protocol. GW and ML provided clinical consultation on trial implementation. DJC, DRT, GM, CLO, ML, GW, and SK reviewed the protocol. ZMJ conducted recruitment and data collection. CLO and GM supervised the clinical aspects of the study. PA and SK conducted statistical analyses. All authors have read and approved the final version of the manuscript.

The data that support the findings of this study are available from the corresponding author (CO), upon reasonable request.

Disclosure statement

David Castle: potential conflicts of interest (past 36 months: January 2022): DC has received grant monies for research from Servier, Boehringer Ingelheim; Travel Support and Honoraria for Talks and Consultancy from Servier, Seqirus, Lundbeck. He is a founder of the Optimal Health Program (OHP), and holds 50% of the IP for OHP; and is part owner of Clarity Healthcare. He does not knowingly have stocks or shares in any pharmaceutical company.

Additional information

Funding

This work was supported through the Australian Government’s Collaborative Research Networks (CRN) program. The funding source was not involved in the conduct of the research or preparation of this manuscript. The OHP was developed at the Mental Health Research Institute of Victoria and St. Vincent’s Hospital Melbourne.