- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03371771
Volunteer-Delivery of Behavioral Activation
October 22, 2020 updated by: Patrick Raue, University of Washington
Volunteer-Delivery of Behavioral Activation for Senior Center Clients
In response to large numbers of senior center clients who suffer untreated depression and the dearth of geriatric mental health providers, the investigators have simplified a Behavioral Activation intervention to match the skill set of age-matched lay volunteers available to senior centers (Volunteer BA).
This R34 proposes developmental work on delivering Volunteer BA in senior centers, so as to arrive to a sustainable intervention with standardized procedures.
The investigators follow with a small randomized controlled trial (RCT) testing the comparative impact of Volunteer BA versus MSW-provided BA on increased client activity and reduced depressive symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Senior centers provide social, health, nutritional, and recreational services to older adults.
Ten percent of older adults in these settings experience clinically significant depression.
Although many aging services now screen for depressive symptoms, an IOM report indicates that the number of geriatric mental health providers nationally is insufficient.
Further complicating treatment delivery is the reluctance of depressed elders to accept a mental health referral or pursue treatment.
It has been proposed that lay workers may be able to offer psychosocial interventions for geriatric mental health disorders.
Lay volunteer-delivered interventions may improve depression outcomes, may do so by engaging the same target variables as professionally-delivered interventions, and may be both more cost effective and acceptable to seniors.
Limitations include uncertainties about training and supervision needs, reliable methods to assure intervention fidelity and patient safety, and comparability of outcomes to those attained by professionally- delivered interventions.
Building on senior centers' volunteer programs, this proposal utilizes senior volunteers to meet the mental health needs of depressed urban clients.
To this end, the investigators simplified Behavioral Activation (BA) to match the skill set of lay senior volunteers (Volunteer BA).
The investigators chose BA because it is an effective treatment for late-life depression, can be administered by paraprofessionals, and its primary mechanism (target) of action has been validated by efficacy studies.
Based on preliminary data, the investigators aim to test the feasibility and acceptability of Volunteer BA for an underserved and difficult to engage population.
The investigators propose further developmental work on the delivery of Volunteer BA in senior centers, so as to arrive at a sustainable intervention with standardized procedures.
The investigators propose a small RCT testing the impact of Volunteer BA versus MSW-delivered standard BA on increased client activity (the target) and reduced depressive symptoms (clinical outcome).
The Volunteer BA delivery model: 1. Makes use of existing volunteer resources; 2. has potential for being an acceptable and sustainable intervention; and 3. is expected to engage BA targets.
However, its capacity to yield comparable outcomes to MSW-delivered BA is yet to be determined.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98103
- Greenwood Senior Center
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Seattle, Washington, United States, 98103
- Wallingford Senior Center
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Seattle, Washington, United States, 98118
- Southeast Senior Center
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Seattle, Washington, United States, 98144
- Central Area Senior Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Referral to study (stage 1):
- Age ≥ 60 years.
- Attends one of 4 participating Seattle senior centers.
- PHQ-9 score of ≥10 via routine screening.
Research assessment (stage 2):
- Mini Mental State Exam (MMSE) ≥ 24.
- Capacity to provide written consent for both research assessment and the BA intervention.
Exclusion Criteria:
- Current passive or active suicidal ideation (SCID-V or HAM-D).
- Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or anxiety disorder by SCID-V.
- Severe or life-threatening medical illness (e.g., end stage organ failure).
- Inability to speak English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Volunteer-delivered Behavioral Activation
|
Behavioral Activation as delivered by trained volunteers
|
|
Active Comparator: MSW-delivered Behavioral Activation
|
Behavioral Activation as delivered by trained MSWs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Behavioral Activation for Depression Scale (BADS) scores
Time Frame: Baseline and 9 weeks
|
The Behavioral Activation for Depression Scale (range 0-150; higher scores indicate higher levels of activation) change score from baseline to 9 weeks
|
Baseline and 9 weeks
|
|
Change from Baseline in Hamilton Rating Scale for Depression (HAM-D) scores
Time Frame: Baseline and 9 weeks
|
Hamilton Depression Rating Scale for Depression (range 0-76; higher scores indicate greater severity of depression) change score from baseline to 9 weeks
|
Baseline and 9 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick J Raue, PhD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2017
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
December 8, 2017
First Submitted That Met QC Criteria
December 8, 2017
First Posted (Actual)
December 13, 2017
Study Record Updates
Last Update Posted (Actual)
October 26, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002543
- R34MH111849 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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