Menu
Recruiting NCT06415838

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

No phase Interventional Depression Depressive Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief Behavioral Activation, Care as Usual.
Who it may be relevant to
Registry conditions: Depression, Depressive Symptoms. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context: a Randomized Controlled Trial

Overview

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.

Detailed description

One third of the Swedish population aged 70 years and above report depressive symptoms, and between 5 - 15% have a major depressive disorder. Depression in older adults reduces quality of life and functional ability, and is associated with an increased risk for morbidity and mortality. Psychological treatment is considered a first-line treatment for depression, but is currently only offered to about 3% of older adults with depression in Sweden. A majority of older adults suffering from depression in Sweden are likely not to be identified and diagnosed, and thereby not treated for their depression. Furthermore, many older adults receive municipal care, and psychological treatment is currently not available in this context.

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 therapists in the trial are social workers working in Eskilstuna municipality in Sweden.

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. The BA-treatment will be delivered in the participants' home. All participants will answer a questionnaire in the beginning of the study, after two months, and after 3-, 6- and 12 months.

The main questions that the trial 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

Interventions

  • Behavioral Brief Behavioral Activation
    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
  • Other Care as Usual
    Care as Usual provided by primary care and/or municipal care.

Primary outcome measures

  • Montgomery-Åsberg Depression Rating Scale, MADRS-S [Time frame: 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 outcome measures (9)
  • Geriatric Depression Scale 15, GDS-15 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group]
  • The New General Self-Efficacy Scale, S-GSE [Time frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group]
  • EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L [Time frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group]
  • Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWBS [Time frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group]
  • Need for municipal care service [Time frame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Eskilstuna kommun — Eskilstuna

Identifiers

NCT: NCT06415838 · DePrevent

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗