Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study)

Area of Science:

• Health Services Research
• Mental Health
• Economic Evaluation

Background:

• Depression and debt are prevalent issues in the UK.
• The Debt Counselling for Depression in Primary Care (DeCoDer) pilot trial aimed to assess the effectiveness of integrating debt counselling into primary care for patients with depression and debt.
• The study was terminated early during its internal pilot phase due to recruitment challenges.

Purpose of the Study:

• To assess the feasibility of a main trial by identifying and resolving issues during the internal pilot phase.
• To confirm recruitment methods, intervention acceptability, contamination, randomisation, attrition rates, and data collection systems.
• To evaluate the clinical and cost-effectiveness of adding a primary care debt counselling service to usual care.

Main Methods:

• An adaptive, parallel, two-group, multicentre randomised controlled pilot trial with a nested mixed-methods process and economic evaluation.
• Both individual- and cluster-level randomisation (general practice) were employed.
• Participants aged 18+ with depression (Beck Depression Inventory II score ≥14) and debt worries were included, with specific exclusion criteria for suicidality, psychosis, severe addiction, and recent debt advice.

Main Results:

• Only 61 out of 238 (26%) expressions of interest were recruited and randomised.
• Participant attrition was 14.7% at 4 months' follow-up.
• Qualitative findings indicated a complex interplay between debt and depression, influenced by other psychosocial factors.

Conclusions:

• The trial was terminated prematurely due to insufficient recruitment, limiting statistical analysis.
• Recommendations are provided for future complex trials involving vulnerable populations in community settings.
• These recommendations cover trial design, intervention delivery, recruitment strategies, and site support to mitigate risks and improve feasibility.