Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSormland County Council, Sweden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Brief Behavioral Activation
BehavioralA 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 interventionCare as Usual provided by primary care and/or municipal care.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Brief Behavioral Activation plus Care as UsualExperimental treatment 2 interventions
Group B: Care as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 groupSecondary outcomes
1
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.
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 group2
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.
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 group3
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.
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 group4
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.
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 groupSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sormland County Council, Sweden
Lead sponsor
Eskilstuna municipality
Collaborator
Source ClinicalTrials.gov