Clinical trial NCT06284889: Behavioral Activation for the Treatment of Depression in Older Adults
Official title: Behavioral Activation for the Treatment of Depression in Older Adults: A Randomised Controlled Multicenter Trial in Primary Care (DepActive)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Keywords: Behavioral activation
Older adults
Activity
Primary care
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Västmanland County Council, Sweden
name: Sormland County Council, Sweden
name: Uppsala County Council, Sweden
First posted: 2024-02-29
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled multi-center trial
Primary purpose: TREATMENT

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.

Detailed description: In Sweden, depression among the elderly is a major public health concern. Major depression occurred in 5-15 % of the older population in Sweden, and one third of the women and a fifth of the men 65 years and older reported subclinical depressive symptoms. Several mental health experts raise concerns that there will be an increase of psychiatric illness during and after COVID-19, particularly among the elderly.

Depression in older individuals can be treated with antidepressant medication, psychological interventions and physical activity. However, the majority of the older individuals state that they would prefer psychological treatments to medication, which poses a challenge during COVID-19 as such treatments are often delivered face-to-face. Psychological treatments delivered via the Internet are as efficacious as face-to-face, but only 3-4% of the individuals 65 years and above in Sweden use digital applications that replace physical healthcare visits.

The purpose of this randomised controlled multicenter study is to evaluate the effects and outcomes of a telephone-delivered Behavioral Activation-treatment for older adults with depression in primary care within the framework of the research project DepActive. Our study specifically aims to: 1. investigate the effect of a telephone-delivered BA-treatment for older adults with depression in primary care with regards to a. depressive symptoms (primary outcome measure) b. depression diagnosis c. anxiety symptoms d. quality of life e. activity level f. functional ability g. cognitive function h. loneliness i. self-efficacy j. cost effectiveness k. care consumption including pharmacological treatment 2. explore patients' and therapists' experiences of the treatment 3. investigate to which extent the BA-treatment corresponds to person-centered care 4. investigate the mediating role of type of activity and level of physical activity with regards to improvement in depressive symptoms 5. investigate whether the intervention impacts the need for community healthcare services for participants utilizing such services.

The study is a multi-center randomised controlled clinical trial in primary care in the Swedish county councils of Vastmanland, Uppsala and Sormland.

Participants will be recruited from multiple primary care centers in each region. If the participant is enrolled in the study, the study therapist performs the randomisation by using an online randomisation software with a 1:1, random-blocks sequence. The participants are randomised consecutively to two arms: control group or intervention group. The control group will receive treatment as usual (TAU) in primary care, and the intervention group will receive TAU with the addition of a five-session telephone-based BA-intervention over an eight-week period.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in depressive symptoms using the Montgomery-Asberg Depression Rating Scale, MADRS-S
timeFrame: Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.
Secondary outcomes:
measure: Change from baseline in depression diagnosis assessed using the Mini International Neuropsychiatric Interview, MINI
timeFrame: Baseline; Intervention 1 Week 9; 6 months post-intervention.
measure: Change from baseline in Physical Activity level
timeFrame: Baseline; Intervention 1 Week 9; 6 months post-intervention.
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.
timeFrame: Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.
measure: Change from baseline in health and disability using The WHO Disability Assessment Schedule 12-item, WHODAS
timeFrame: Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.
measure: Change from baseline in self rated quality of life using the EuroQol-5 Dimensions-5 Level Scale, EQ-5D-5L
timeFrame: Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.
measure: Changes from baseline in Self Efficacy measured with the New General Self-Efficacy Scale, S-GSE.
timeFrame: Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.
measure: Changes from baseline in loneliness measured with the UCLA Loneliness Scale version 3, UCLA-LS-3.
timeFrame: Baseline; Intervention 1 Week 9; 3 months post-intervention; 6 months post-intervention.
measure: Diagnostic accuracy
timeFrame: Baseline; Week 0
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university
state: Uppland
Study officials:
affiliation: Uppsala university, Dept. Public Care and Health Sciences
name: Mattias Damberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.