Ireland
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Starting soon Not applicable

Behavioral Activation for the Treatment of Depression in Older Adults

NCT06284889 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2024-03-04
Last updated
2024-02-29

Condition(s) studied

Depression

Investigational drug(s) / intervention(s)

Behavioural activationTreatment as usual (TAU)

Behavioural activation: Session 1: Face-to-face; Psychoeducation about depression; treatment rationale for Behavioral Activation (BA); rationale and instructions for activity log; Session 2: Via telephone; Discussion of life goals and values; planning of activities aligned with life goals and values for coming week Session 3: Via telephone; Troubleshooting any problems carrying out activities; planning activities aligned with life goals and values for coming week. Session 4: Via telephone; Troubleshooting any problems carrying out activities; planning activities aligned with life goals and values for the coming week; instructing the participant to independently continue to plan activities for the coming month. Session 5: Via telephone; Troubleshooting any problems carrying out activities; reviewing treatment; stressing the importance of continuing to engage in activities aligned with life goals and values; creating a maintenance plan.

Treatment as usual (TAU): Treatment as usual regarding depression received at their primary care centre.

Study summary

Depression affects between 5-15% of adults ≥ 65 years in Sweden. Depression in older adults reduces functional ability and quality of life, and increases the risk for morbidity, loneliness, and suicide. Psychological treatment is recommended as a first-line treatment for depression, which about 3% of older adults with depression in Sweden report receiving. One effective psychological treatment is behavioral activation, which reduces depressive symptoms by increasing enjoyable, meaningful and important activities, for example exercise and social activities. The research group conducted a pilot study of telephone based behavioral activation for isolated older adults with depression during the COVID-19 pandemic. The intervention consisted of four telephone calls, and the results showed a significant decrease in depressive symptoms, with maintained effects for six months.

250 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center. Participants will be asked to fill in questionnaires before, after treatment. Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results. Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline, post-intervention and after 3-months. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants should fulfill criteria for current major depressive episode or sub-threshold depressive episode. * Eligible participants should be 65 years or older, should be fluent in spoken and written Swedish to understand the treatment materials, have access to telephone, and be interested in participating in the trial. Exclusion Criteria: * Severe depression, elevated suicide risk, current substance use disorder, current or previous manic or hypomanic episodes, current psychotic disorder, and current diagnosis of minor or major neurocognitive disorder or suspected neurocognitive disorder with \< 24 points on the Mini Mental State Examination number 3, MMSE-NR3. * ongoing psychotherapy

Primary outcome measure(s)

  • Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S — Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.
    Depressive symptoms measured with the Montgomery-Asberg Depression Rating Self-rating Scale, MADRS-S. MADRS-S is a nine-item questionnaire used to measure severity of depression. The score ranges from 0-54. High scores indicate more depressive symptoms.

Trial sites (1)

FacilityCityRegionStatus
Uppsala university Uppsala Uppland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06284889 on ClinicalTrials.gov ↗ ← All trials in Sweden