Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context

NCT06415838 | Recruiting

• 1 other identifier: DePrevent
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to investigate if a brief psychological treatment called Behavioral Activation (BA) works to prevent and treat depression in older adults in a municipal context in Sweden. It will also learn about the patients' and therapists' experiences of the BA-treatment. The main questions it aims to answer are if the BA-treatment has an effect on the short and long term on:

• Depressive symptoms
• Anxiety symptoms
• Self-rated activation
• Functional ability
• Loneliness
• Self efficacy
• Mental wellbeing
• Quality of life
• Need for community care services All participants will continue their care as usual (CAU), and half of the participants will be randomized to receive a five-session BA-treatment spread over two months as an add-on to CAU. All participants will answer a questionnaire in the beginning of the study, after two months, and after 3-, 6- and 12 months.

Conditions

Depression; Depressive Symptoms

Keywords

Behavioral activation; Behavior therapy; Psychological treatment; Older adults; Geriatric

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale, MADRS-S

  Depressive symptoms will be measured with the Montgomery-Åsberg Depression Rating Self-rating Scale (MADRS-S). The MADRS-S is a nine-item questionnaire designed to measure depression severity during the past two weeks. The total score ranges from 0-54, with higher scores indicating higher depression severity.

  Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group

Secondary Outcomes (9)

• Geriatric Depression Scale 15, GDS-15

  Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group

• Geriatric Anxiety Scale 10, GAS-10

  Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group

• WHO disability assessment schedule 12-item, WHODAS-12

  Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group

• Behavioral activation for depression scale - short form, BADS-SF

  Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group

• UCLA Loneliness Scale version 3, UCLA-LS 3

  Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group

Study Arms (2)

Brief Behavioral Activation plus Care as Usual

EXPERIMENTAL

Five-session Brief Behavioral Activation intervention. Sessions 1 - 4 are completed once a week, and session 5 is a booster-session completed four weeks after session 4.

Behavioral: Brief Behavioral Activation; Other: Care as Usual

Care as Usual

ACTIVE COMPARATOR

Care as usual as provided by primary care and/or municipal care.

Other: Care as Usual

Interventions

Brief Behavioral Activation BEHAVIORAL

A five-session brief behavioral activation treatment delivered face-to-face in the participants' home. Session outline: Session 1: Psychoeducation about depression; treatment rationale for Behavioral Activation (BA); rationale and instructions for activity log Session 2: Discussion of life goals and values; planning of activities aligned with life goals and values for coming week Session 3: Troubleshooting any problems carrying out activities; planning activities aligned with life goals and values for coming week. Session 4: 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: 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.

Brief Behavioral Activation plus Care as Usual

Care as Usual OTHER

Care as Usual provided by primary care and/or municipal care.

Brief Behavioral Activation plus Care as Usual; Care as Usual

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years or older
• points or above on the Geriatric Depression Scale 15, GDS-15
• Fluent in written and spoken Swedish
• Consents to participate in the trial

You may not qualify if:

• Not able to use the patient materials due to visual impairment
• Not able to communicate with therapist due to hearing impairment
• Diagnosis of major neurocognitive disorder
• Below 25 points on the Mini Mental State Examination, MMSE
• Elevated suicide risk
• Current substance- or alcohol use disorder
• Previous or current psychotic disorder
• Previous or current bipolar disorder
• Ongoing psychological treatment/pscyhotherapy

Sponsors & Collaborators

• Sormland County Council, Sweden: lead
• Eskilstuna municipality: collaborator

Study Sites (1)

Eskilstuna kommun

Eskilstuna, Sörmland, Sweden

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Johnny Pellas, PhD

  Research and Development Sormland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnny Pellas, PhD

CONTACT

+46702319795; johnny.pellas@pubcare.uu.se

Marina Arkkukangas, PhD

CONTACT

marina.arkkukangas@fou.sormland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: June 27, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and statistical analysis plan to be shared/published before data collection has ended.

Locations

SE (1)