protocolSection identificationModule nctId: NCT06284889, orgStudyIdInfo id: DepActive, briefTitle: Behavioral Activation for the Treatment of Depression in Older Adults, acronym: DepActive, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: Västmanland County Council, Sweden, collaborators name: Sormland County Council, Sweden, collaborators name: Uppsala County Council, Sweden, descriptionModule briefSummary: Depression affects between 5-15% of adults ≥ 65 years in Sweden. Depression in older adults reduces functional ability and quality of life, and increases the risk for morbidity, loneliness, and suicide. Psychological treatment is recommended as a first-line treatment for depression, which about 3% of older adults with depression in Sweden report receiving. One effective psychological treatment is behavioral activation, which reduces depressive symptoms by increasing enjoyable, meaningful and important activities, for example exercise and social activities. The research group conducted a pilot study of telephone based behavioral activation for isolated older adults with depression during the COVID-19 pandemic. The intervention consisted of four telephone calls, and the results showed a significant decrease in depressive symptoms, with maintained effects for six months.250 individuals will participate in the study. Half of the participants will be randomised to start the intervention immediately, while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center. Participants will be asked to fill in questionnaires before, after treatment. Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results. Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline, post-intervention and after 3-months. A smaller group of participants (10-15) will be asked to participate in a more detailed interview about how they experienced the treatment., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled multi-center trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Behavioural activation, interventions name: Treatment as usual (TAU), outcomesModule primaryOutcomes measure: Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S, secondaryOutcomes measure: Change from baseline in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI, secondaryOutcomes measure: Change from baseline in Physical Activity level, secondaryOutcomes measure: Change from baseline in anxiety symptoms using the Geriatric Anxiety Scale - 10 item (GAS-10) is a self-rating scale designed to capture anxiety specifically in older adults, with items reflecting affective-, cognitive- and somatic anxiety symptoms., secondaryOutcomes measure: Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS, secondaryOutcomes measure: Change from baseline in self rated quality of life using the EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L, secondaryOutcomes measure: Changes from baseline in Self Efficacy measured with the New General Self-Efficacy Scale, S-GSE., secondaryOutcomes measure: Changes from baseline in loneliness measured with the UCLA Loneliness Scale version 3, UCLA-LS-3., secondaryOutcomes measure: Diagnostic accuracy, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Uppsala university, city: Uppsala, state: Uppland, zip: 753 10, country: Sweden, contacts name: Mattias Damberg, MD, role: CONTACT, phone: +46739480910, email: mattias.damberg@pubcare.uu.se, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False