Clinical trial NCT06415838: Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context
Official title: Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Depressive Symptoms
Keywords: Behavioral activation
Behavior therapy
Psychological treatment
Older adults
Geriatric
Lead sponsor: Sormland County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Eskilstuna municipality
First posted: 2024-05-16
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale, MADRS-S
timeFrame: 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:
measure: Geriatric Depression Scale 15, GDS-15
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
measure: Geriatric Anxiety Scale 10, GAS-10
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
measure: WHO disability assessment schedule 12-item, WHODAS-12
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
measure: Behavioral activation for depression scale - short form, BADS-SF
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
measure: UCLA Loneliness Scale version 3, UCLA-LS 3
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
measure: The New General Self-Efficacy Scale, S-GSE
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
measure: EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
measure: Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWBS
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
measure: Need for municipal care service
timeFrame: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Eskilstuna kommun
state: Sörmland
Study officials:
affiliation: Research and Development Sormland
name: Johnny Pellas, PhD
role: PRINCIPAL_INVESTIGATOR
References: