DepressionDePreventNCT06415838
Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context
A study testing Brief Behavioral Activation and Care as Usual in people with Depression and Depressive Symptoms, run by Sormland County Council, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression, Depressive Symptoms
- What is being tested?
- Brief Behavioral Activation and Care as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- 27 Jun 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Previous or current psychotic disorder
- Previous or current bipolar disorder
- Ongoing psychological treatment/pscyhotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marina Arkkukangas, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Eskilstuna kommun
Eskilstuna, Sörmland
Johnny Pellas, PhD, +46702319795, johnny.pellas@uu.se
About this study
Official title: Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context: a Randomized Controlled 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:
Read more
- 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.
Read the 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
- Depression, Depressive Symptoms
- Being tested
- Brief Behavioral Activation, Care as Usual
- Keywords
- Behavioral activation, Behavior therapy, Psychological treatment, Older adults, Geriatric
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral ActivationBehavioural
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 UsualOther
Care as Usual provided by primary care and/or municipal care.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Activation plus Care as Usual | Experimental | 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. Receives: Behavioral: Brief Behavioral Activation; Other: Care as Usual |
| Care as Usual | Active comparator | Care as usual as provided by primary care and/or municipal care. Receives: Other: Care as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (9)
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.
Measured: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
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.
Measured: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
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.
Measured: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
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.
Measured: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
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.
Measured: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
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.
Measured: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
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.
Measured: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
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.
Measured: 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
Need for municipal care service will be measured by recording types of services and number of hours granted by the municipality for each participant.
Measured: Baseline; post-intervention or equivalent for control group 9 weeks after baseline; 3-, 6- and 12 months post-intervention or equivalent for control group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start27 Jun 2024
- Primary completionDec 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sormland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Eskilstuna municipality
- Responsible party
- Sponsor
- Investigators
- Johnny Pellas, PhD, Principal investigator, Research and Development Sormland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415838
- Sponsor's protocol ID
- DePrevent
- Acronym
- DePrevent
- Status last verified
- Dec 2024
- First submitted
- 7 May 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation for the Prevention and Treatment of Depression in Older Adults in a Municipal Context: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06415838
- Acronym / sponsor ID
- DePrevent / DePrevent
- Conditions
- Depression, Depressive Symptoms
- Keywords
- Behavioral activation, Behavior therapy, Psychological treatment, Older adults, Geriatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sormland County Council, SwedenUniversity, hospital or other
- Collaborators
- Eskilstuna municipality
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Activation plus Care as Usual | Experimental | Behavioral: Brief Behavioral Activation, Other: Care as UsualFive-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. |
| Care as Usual | Active comparator | Other: Care as UsualCare as usual as provided by primary care and/or municipal care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Behavioral ActivationA 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. | Behavioural | Brief Behavioral Activation plus Care as Usual |
| Care as UsualCare as Usual provided by primary care and/or municipal care. | Other | Brief Behavioral Activation plus Care as Usual, Care as Usual |
Primary outcome
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marina Arkkukangas, PhD contact
Johnny Pellas, PhD principal investigator
Research and Development Sormland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Activation and Care as Usual in people with Depression and Depressive Symptoms, run by Sormland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johnny Pellas, PhD (+46702319795, johnny.pellas@pubcare.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.