Behavioral Activation for the Treatment of Depression in Older Adults

NCT06284889 | Not Yet Recruiting

• 1 other identifier: DepActive
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Behavioral activation; Older adults; Activity; Primary care

Outcome Measures

Primary Outcomes (1)

• Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S

  Depressive symptoms measured with the Montgomery-Asberg Depression Rating Self-rating Scale, MADRS-S. MADRS-S is a nine-item questionnaire used to measure severity of depression. The score ranges from 0-54. High scores indicate more depressive symptoms.

  Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.

Secondary Outcomes (8)

• Change from baseline in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI

  Baseline; Intervention 1 Week 9; 6 months post-intervention.

• Change from baseline in Physical Activity level

  Baseline; Intervention 1 Week 9; 6 months post-intervention.

• 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.

  Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.

• Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS

  Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.

• Change from baseline in self rated quality of life using the EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L

  Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.

Study Arms (2)

Treatment

EXPERIMENTAL

Brief Behavioral Activation

Behavioral: Behavioural activation; Other: Treatment as usual (TAU)

Treatment as usual (TAU)

PLACEBO COMPARATOR

Treatment as usual regarding depression received at their primary care centre.

Other: Treatment as usual (TAU)

Interventions

Behavioural activation BEHAVIORAL

Session 1: Face-to-face; Psychoeducation about depression; treatment rationale for Behavioral Activation (BA); rationale and instructions for activity log; Session 2: Via telephone; Discussion of life goals and values; planning of activities aligned with life goals and values for coming week Session 3: Via telephone; Troubleshooting any problems carrying out activities; planning activities aligned with life goals and values for coming week. Session 4: Via telephone; 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: Via telephone; 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.

Treatment

Treatment as usual (TAU) OTHER

Treatment as usual regarding depression received at their primary care centre.

Treatment; Treatment as usual (TAU)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants should fulfill criteria for current major depressive episode or sub-threshold depressive episode.
• Eligible participants should be 65 years or older, should be fluent in spoken and written Swedish to understand the treatment materials, have access to telephone, and be interested in participating in the trial.

You may not qualify if:

• Severe depression, elevated suicide risk, current substance use disorder, current or previous manic or hypomanic episodes, current psychotic disorder, and current diagnosis of minor or major neurocognitive disorder or suspected neurocognitive disorder with \< 24 points on the Mini Mental State Examination number 3, MMSE-NR3.
• ongoing psychotherapy

Sponsors & Collaborators

• Uppsala University: lead
• Västmanland County Council, Sweden: collaborator
• Sormland County Council, Sweden: collaborator
• Uppsala County Council, Sweden: collaborator

Study Sites (1)

Uppsala university

Uppsala, Uppland, 753 10, Sweden

Location

Related Publications (4)

• Pellas J, Renner F, Ji JL, Damberg M. Telephone-Based Behavioral Activation with Mental Imagery for Depression in Older Adults in Isolation During the covid-19 Pandemic: Long-term Results from a Pilot Trial. Clin Gerontol. 2023 Jan-Dec;46(5):801-807. doi: 10.1080/07317115.2022.2124899. Epub 2022 Sep 20.

  PMID: 36128612 RESULT

• Pellas J, Renner F, Ji JL, Damberg M. Telephone-based behavioral activation with mental imagery for depression: A pilot randomized clinical trial in isolated older adults during the Covid-19 pandemic. Int J Geriatr Psychiatry. 2022 Jan;37(1):10.1002/gps.5646. doi: 10.1002/gps.5646. Epub 2021 Nov 10.

  PMID: 34729823 RESULT

• Pellas J, Damberg M. Accuracy in detecting major depressive episodes in older adults using the Swedish versions of the GDS-15 and PHQ-9. Ups J Med Sci. 2021 Oct 20;126. doi: 10.48101/ujms.v126.7848. eCollection 2021.

  PMID: 34754407 RESULT

• Bystrom E, Wennlof B, Johansson I, Lonnberg L, Arkkukangas M, Pellas J, Damberg M. DepActive: study protocol for a randomised controlled multicentre trial of telephone-delivered behavioural activation for the treatment of depression in older adults in primary care. Trials. 2024 Oct 5;25(1):659. doi: 10.1186/s13063-024-08521-y.

  PMID: 39369239 DERIVED

MeSH Terms

Conditions

Depression; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Mattias Damberg, MD

  Uppsala university, Dept. Public Care and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Damberg, MD

CONTACT

+46739480910; mattias.damberg@pubcare.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled multi-center trial

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 29, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)