Volunteer-Delivery of Behavioral Activation

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT03371771
Collaborator
National Institute of Mental Health (NIMH) (NIH)
55
4
2
36.5
13.8
0.4

Study Details

Study Description

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
  • Behavioral: Volunteer-delivered Behavioral Activation
  • Behavioral: MSW-delivered Behavioral Activation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to receive either Volunteer or MSW-delivered Behavioral ActivationParticipants 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 :
Sep 15, 2017
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Sep 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Behavioral Activation for Depression Scale (BADS) scores [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

  2. Change from Baseline in Hamilton Rating Scale for Depression (HAM-D) scores [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Greenwood Senior Center Seattle Washington United States 98103
2 Wallingford Senior Center Seattle Washington United States 98103
3 Southeast Senior Center Seattle Washington United States 98118
4 Central Area Senior Center Seattle Washington United States 98144

Sponsors and Collaborators

  • University of Washington
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Patrick J Raue, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patrick Raue, Professor, School of Medicine: Psychiatry: Population Health, University of Washington
ClinicalTrials.gov Identifier:
NCT03371771
Other Study ID Numbers:
  • STUDY00002543
  • R34MH111849
First Posted:
Dec 13, 2017
Last Update Posted:
Oct 26, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2020