Depression Clinical Trial
— DePreventOfficial title:
Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context: A Randomized Controlled Trial
NCT number | NCT06415838 |
Other study ID # | DePrevent |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | August 2026 |
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.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | August 2026 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sormland County Council, Sweden | Eskilstuna municipality |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Geriatric Depression Scale 15, GDS-15 | 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. | 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 | Geriatric Anxiety Scale 10, GAS-10 | 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. | 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 | WHO disability assessment schedule 12-item, WHODAS-12 | 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. | 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 | Behavioral activation for depression scale - short form, BADS-SF | 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. | 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 | UCLA Loneliness Scale version 3, UCLA-LS 3 | 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. | 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 | The New General Self-Efficacy Scale, S-GSE | 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. | 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 | EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L | 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. | 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 | Short Warwick-Edinburgh Mental Wellbeing Scale, SWEMWBS | 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. | 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 | Need for municipal care service | Need for municipal care service will be measured by recording types of services and number of hours granted by the municipality for each participant. | Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group |
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