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NCT Number: NCT04621877

Lay-Delivered Behavioral Activation in Senior Centers

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 Behavioral Activation to be delivered by lay volunteers ("Do More, Feel Better"; DMFB). The focus of Behavioral Activation is to guide clients to reengage in daily pleasant and rewarding activities, and reduce depressive symptoms. If the investigators can show that the lay delivery model has positive impact in comparison to MSW-delivered Behavioral Activation, the investigators will have identified an effective intervention that can be used by a large untapped workforce of older adult volunteers across the nation.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brandon Senior Center, Brandon, Florida, United States

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About this study

This Collaborative R01 application (UW, Cornell, USF) proposes to conduct an effectiveness trial of lay-delivered Behavioral Activation ("Do More, Feel Better"; DMFB), in comparison to MSW-delivered Behavioral Activation (MSW BA), for depressed (PHQ-9>10 and Ham-D>14) older (60+) senior center clients. The primary aim tests the effectiveness of DMFB, in comparison to MSW BA, on increasing overall activity level (target) and reducing depression symptoms. The investigators will test whether increased activity level predicts greater reduction in depression severity and whether increased activity's impact on depression is non-inferior across conditions. Secondarily, the investigators will test hypotheses associated with overall functioning, satisfaction with treatment, and client-level moderators. Lastly the investigators will explore longer-term client outcomes, delivery cost, and preparing for sustainability by exploring client, provider, and center factors related to intervention fidelity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Client Participants (anticipated enrollment: 288)

Inclusion criteria

Referral to study (stage 1):

  • Age ≥ 60 years.
  • Attends one of 18 participating Seattle, NYC, or Tampa area senior centers.
  • Patient Health Questionnaire (PHQ-9) score of ≥10 via routine screening.

Research assessment (stage 2):

  • Clinically-assessed HAM-D>14
  • Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19
  • Off antidepressants or on a stable dose for 12 weeks.
  • Capacity to provide written consent for both research assessment and the BA intervention.

Client Participants Exclusion Criteria:

  • Current active suicidal ideation.
  • Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-V (Structure Clinical Interview for DSM-V).
  • Severe or life-threatening medical illness (e.g., end stage organ failure).
  • Inability to speak English or Spanish

Volunteer Participants (anticipated enrollment: 36) Inclusion Criteria

  • Age ≥ 60 years.
  • Attends one of the participating Seattle, NYC, or Tampa-area senior centers.

Volunteer Participants Exclusion Criteria

  • Current major depressive disorder, alcohol or substance abuse, or manic, hypomanic, or psychotic symptoms (SCID-V);
  • Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19;
  • Inability to speak and read English or Spanish

Clinician Participants (anticipated enrollment: 36) Inclusion Criteria

  • Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
  • English or Spanish Speaking
  • Capacity to provide consent for all study procedures
  • Willing to audio record study sessions for supervision and evaluation

Clinician Participants Exclusion Criteria

  • Non-English or Non-Spanish speaking
  • Does not hold a Master's degree in social work, counseling, marriage/family, or other clinical mental health degree
  • Unable to provide consent
  • Unwilling to audio record study sessions for supervision and evaluation

Treatment and study plan

Volunteer-delivered Behavioral Activation

Behavioral

Behavioral Activation as delivered by trained volunteers

Master's level clinician-delivered Behavioral Activation

Behavioral

Behavioral Activation as delivered by trained master's level clinicians

Primary outcomes

  1. Hamilton Rating Scale for Depression (HAM-D)

    Time frame: Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts

    The HAM-D will be used as measure of depressive symptom severity. The HAM-D is a clinically administered measure and has been validated in a variety of psychiatric populations.

  2. Behavioral Activation Scale (BADS)

    Time frame: Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts

    The BADS will be used as the primary target measure, and yields a total score reflecting level of engagement in reinforcing activities. The BADS has shown good psychometric properties; studies have validated the BADS as a mechanism by which behavioral activation interventions reduces depression.

Secondary outcomes

  1. World Health Organization Disability Assessment Schedule (WHODAS II)

    Time frame: Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts

    The World Health Organization Disability Assessment Schedule II (WHODAS II)-12 item form will be used to assess overall functioning. This instrument is cross-culturally applicable and treats all disorders at parity when determining level of functioning. The WHODAS II assesses 6 domains: a. understanding and communicating; b.

    getting around; c. self-care; d. getting along with others; e. household and work activities; and f. participation in society. Each domain has factor loading of at least 0.70 and the items also load on a general disability factor which will be used in this proposal.

  2. Client Satisfaction with Treatment (CSQ)- 3 Item

    Time frame: Administered at 3, 6, and 9 weeks after treatment starts

    The 3-item version of the Client Satisfaction Questionnaire (CSQ) will be used as a patient self-report measure of satisfaction with study interventions. The CSQ has high internal consistency and successfully distinguishes degrees of satisfaction even at the high end.

Other outcomes

  1. Intervention Fidelity

    Time frame: Weekly for 9 weeks of treatment

    The "Do More, Feel Better" and BADT-R fidelity forms will be used by external raters to assess each interventionist's fidelity to the respective treatment modality. Global scores range from 0-6, with scores >3 indicating satisfactory levels of fidelity.

Study contacts

Contact information is provided by the study sponsor or research team.

Brittany Mosser

CONTACT

[email protected]

206-616-2129

Dylan Fisher

CONTACT

[email protected]

206-616-2129

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of South Florida
  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2020
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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