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

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
      • Seattle, Washington, United States, 98103
        • Wallingford Senior Center
      • Seattle, Washington, United States, 98118
        • Southeast Senior Center
      • 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):

  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.

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.

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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