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NCT Number: NCT06415838

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskilstuna kommun

Eskilstuna, Sörmland, Sweden

Location status: Recruiting

Location contact

Johnny Pellas, PhD

CONTACT

[email protected]

+46702319795

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Care as usual

Other

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    Depressive symptoms and depression diagnoses will also be measured using the Geriatric Depression Rating Scale 15-item short form (GDS-15), a 15-item questionnaire used to identify depression in older individuals with scores ranging from 0-15, with higher scores indicating higher depression severity.

  2. 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

    Anxiety symptoms will be measured with the Geriatric Anxiety Scale - 10 item version (GAS-10), with a score ranging from 0 - 30, with higher scores indicating higher levels of anxiety.

  3. 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

    Functional impairment will be assessed with the WHO Disability Assessment Schedule 12-item (WHODAS-12), a self-rating scale with 12 items ranging from 0 - 48, with higher scores indicating more functional impairment.

  4. 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

    Self-rated avoidance and activation will be measured using the Behavioral Activation for Depression Scale - Short Form (BADS-SF), a 9-item scale with scores ranging from 0 - 54, with higher scores indicating a higher degree of activation and lower degree of avoidance.

  5. 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

    Subjective feelings of loneliness and social isolation will be measured using the UCLA Loneliness Scale version 3 (UCLA-LS 3), a 20-item scale with scores ranging from 20 - 80 points, with higher scores indicating higher loneliness.

  6. 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

    New General Self-Efficacy Scale (S-GSE) is an 10-item measure with scores ranging between 10 - 40 points, that assesses how much people believe they can achieve their goals, despite difficulties. Higher scores indicate higher levels of self-efficacy.

  7. 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

    Health related quality of life and estimation of quality-adjusted life years (QALY) for health economic evaluations will be measured using the EuroQol-5 Dimensions-5 Level Scale (EQ-5D-5L), a 5-item scale ranging between 1 - 5 per item, measuring health status with regards to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The Eq-5D-5L also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, with higher scores indicating better overall health.

  8. 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

    Self-rated mental wellbeing will be measured with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS), a 7-item scale with scores ranging from 7 - 35, with higher scores indicating higher positive mental wellbeing.

  9. 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

    Need for municipal care service will be measured by recording types of services and number of hours granted by the municipality for each participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Johnny Pellas, PhD

CONTACT

[email protected]

+46702319795

Marina Arkkukangas, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sormland County Council, Sweden

Other

Collaborators

  • Eskilstuna municipality

Registry information

Official study title

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

Acronym: DePrevent

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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