DepActive: study protocol for a randomised controlled multicentre trial of telephone-delivered behavioural activation for the treatment of depression in older adults in primary care

Background: Depression is common in older adults and is related to reduced quality of life and functional ability as well as increased mortality and morbidity. Current guidelines recommend psychological treatments for the treatment of depression in adults. Studies show that about 30% of older adults with depression in Sweden receive pharmacological treatment and about 3% receive psychological treatment. However, a majority receive no treatment at all. There is a need for effective and scalable psychological treatment options for older adults with depression in primary care. Behavioural activation is an extensively evaluated, effective, and relatively simple treatment for depression that can be delivered by health care professionals without comprehensive training in psychological treatment.

Methods: We will conduct a randomised controlled 2-armed parallel group multicentre trial comparing treatment as usual in primary care to a five-session telephone-delivered behavioural activation treatment as add on to treatment as usual. The current trial is open labelled. In all, 250 older adults (≥ 65 years) with depression will be recruited from primary healthcare centres in three Swedish regions. The primary outcome is depressive symptoms measured with the Montgomery Åsberg Depression Rating Scale - Self rating version (MADRS-S) after treatment and at 3- and 6-month follow-up. Secondary outcomes include depression diagnoses, activity level (self-rated and measured with accelerometer), and self-rated anxiety, daily functioning, quality of life, self-efficacy, and loneliness.

Discussion: There is a need for fully powered studies of brief behavioural activation for older adults with depression delivered by telephone in a primary care context. This study has the potential to improve first-line treatment of depression in older adults in primary care, consequently reducing morbidity and mortality within this population. Increasing the availability and accessibility to effective psychological treatment for depression in older adults is needed to meet future demographic changes.

Trial registration: ClinicalTrials.gov: NCT06284889 . Registered February 28, 2024.