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Volunteer-Delivery of Behavioral Activation

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ClinicalTrials.gov Identifier: NCT03371771
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Patrick Raue, University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Volunteer-delivered Behavioral Activation Behavioral: MSW-delivered Behavioral Activation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to receive either Volunteer or MSW-delivered Behavioral Activation
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Volunteer-Delivery of Behavioral Activation for Senior Center Clients
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Volunteer-delivered Behavioral Activation Behavioral: Volunteer-delivered Behavioral Activation
Behavioral Activation as delivered by trained volunteers

Active Comparator: MSW-delivered Behavioral Activation Behavioral: MSW-delivered Behavioral Activation
Behavioral Activation as delivered by trained MSWs




Primary Outcome Measures :
  1. Change from Baseline in Behavioral Activation for Depression Scale (BADS) scores [ Time Frame: Baseline and 12 weeks ]
    The Behavioral Activation for Depression Scale (range 0-150; higher scores indicate higher levels of activation) change score from baseline to 12 weeks

  2. Change from Baseline in Hamilton Rating Scale for Depression (HAM-D) scores [ Time Frame: Baseline and 12 weeks ]
    Hamilton Depression Rating Scale for Depression (range 0-76; higher scores indicate greater severity of depression) change score from baseline to 12 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371771


Contacts
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Contact: Patrick J Raue, Ph.D. 206-543-3807 praue@uw.edu

Locations
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United States, Washington
Greenwood Senior Center Recruiting
Seattle, Washington, United States, 98103
Contact: Cecliy Kaplan, BA    206-297-0875    cecily@phinneycenter.org   
Wallingford Senior Center Recruiting
Seattle, Washington, United States, 98103
Contact: Claire Petersky, BA    206-461-7825    cpetersky@wallingfordseniors.org   
Southeast Senior Center Recruiting
Seattle, Washington, United States, 98118
Contact: Lynda Greene, BA    206-722-0317 ext 100    lyndag@soundgenerations.org   
Central Area Senior Center Recruiting
Seattle, Washington, United States, 98144
Contact: Dian Ferguson, BA    206-726-4926    dianf@soundgenerations.org   
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Patrick J Raue, PhD University of Washington

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Responsible Party: Patrick Raue, Professor, School of Medicine: Psychiatry: Population Health, University of Washington
ClinicalTrials.gov Identifier: NCT03371771    
Other Study ID Numbers: STUDY00002543
R34MH111849 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms