Volunteer-Delivery of Behavioral Activation

NCT ID: NCT03371771

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to receive either Volunteer or MSW-delivered Behavioral Activation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Volunteer-delivered Behavioral Activation

Group Type EXPERIMENTAL

Volunteer-delivered Behavioral Activation

Intervention Type BEHAVIORAL

Behavioral Activation as delivered by trained volunteers

MSW-delivered Behavioral Activation

Group Type ACTIVE_COMPARATOR

MSW-delivered Behavioral Activation

Intervention Type BEHAVIORAL

Behavioral Activation as delivered by trained MSWs

Interventions

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Volunteer-delivered Behavioral Activation

Behavioral Activation as delivered by trained volunteers

Intervention Type BEHAVIORAL

MSW-delivered Behavioral Activation

Behavioral Activation as delivered by trained MSWs

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Referral to study (stage 1):

1. Age ≥ 60 years.
2. Attends one of 4 participating Seattle senior centers.
3. PHQ-9 score of ≥10 via routine screening.

Research assessment (stage 2):

1. Mini Mental State Exam (MMSE) ≥ 24.
2. Capacity to provide written consent for both research assessment and the BA intervention.

Exclusion Criteria

1. Current passive or active suicidal ideation (SCID-V or HAM-D).
2. Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or anxiety disorder by SCID-V.
3. Severe or life-threatening medical illness (e.g., end stage organ failure).
4. Inability to speak English.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Patrick Raue

Professor, School of Medicine: Psychiatry: Population Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick J Raue, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Greenwood Senior Center

Seattle, Washington, United States

Site Status

Wallingford Senior Center

Seattle, Washington, United States

Site Status

Southeast Senior Center

Seattle, Washington, United States

Site Status

Central Area Senior Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH111849

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00002543

Identifier Type: -

Identifier Source: org_study_id