NCT03371771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable depression

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 26, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

December 8, 2017

Last Update Submit

October 22, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Behavioral Activation for Depression Scale (BADS) scores

    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

    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

Study Arms (2)

Volunteer-delivered Behavioral Activation

EXPERIMENTAL
Behavioral: Volunteer-delivered Behavioral Activation

MSW-delivered Behavioral Activation

ACTIVE COMPARATOR
Behavioral: MSW-delivered Behavioral Activation

Interventions

Behavioral Activation as delivered by trained volunteers

Volunteer-delivered Behavioral Activation

Behavioral Activation as delivered by trained MSWs

MSW-delivered Behavioral Activation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Greenwood Senior Center

Seattle, Washington, 98103, United States

Location

Wallingford Senior Center

Seattle, Washington, 98103, United States

Location

Southeast Senior Center

Seattle, Washington, 98118, United States

Location

Central Area Senior Center

Seattle, Washington, 98144, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Patrick J Raue, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive either Volunteer or MSW-delivered Behavioral Activation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine: Psychiatry: Population Health

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 13, 2017

Study Start

September 15, 2017

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

October 26, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations