## Protocol Section
### Identification Module
**NCT ID:** NCT06415838

**Acronym:** DePrevent

**Brief Title:** 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

#### Organization Study ID Info
**ID:** DePrevent
#### Organization
**Class:** OTHER
**Full Name:** Sormland County Council, Sweden
### Status Module
#### Completion Date
**Date:** 2026-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Eskilstuna municipality

#### Lead Sponsor

**Class:** OTHER

**Name:** Sormland County Council, Sweden

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Depression

- Depressive Symptoms

**Keywords:**

- Behavioral activation

- Behavior therapy

- Psychological treatment

- Older adults

- Geriatric

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 160

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Brief Behavioral Activation

- Other: Care as Usual

**Label:** Brief Behavioral Activation plus Care as Usual

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Care as Usual

**Label:** Care as Usual

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Brief Behavioral Activation plus Care as Usual

**Description:** 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.

**Name:** Brief Behavioral Activation

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Brief Behavioral Activation plus Care as Usual

- Care as Usual

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

**Name:** Care as Usual

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** 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 Outcomes

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** 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

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

**Measure:** 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 Module

**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

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** johnny.pellas@pubcare.uu.se

**Name:** Johnny Pellas, PhD

**Phone:** +46702319795

**Role:** CONTACT

**Contact 2:**

**Email:** marina.arkkukangas@fou.sormland.se

**Name:** Marina Arkkukangas, PhD

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Research and Development Sormland

**Name:** Johnny Pellas, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** Study protocol and statistical analysis plan to be shared/published before data collection has ended.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-31
