DepressionNCT04621877
Lay-Delivered Behavioral Activation in Senior Centers
A study testing Volunteer-delivered Behavioral Activation and Master's level clinician-delivered Behavioral Activation in people with Depression, run by University of Washington at 25 sites in United States.
Trial 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 Behavioral Activation to be delivered by lay volunteers ("Do More, Feel Better"; DMFB). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Volunteer-delivered Behavioral Activation and Master's level clinician-delivered Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 25 sitesUnited States
- Study dates
- 27 Jan 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 31Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites, 18 recruiting
- Recruiting
Brandon Senior Center
Brandon, Florida, 33510
Mary Goldsworthy, 813-974-3576, domorefeelbetter@usf.edu
- Active, not recruiting
Diana Jones Senior Center
Brooklyn, New York, 11206
- Recruiting
Enumclaw Senior Center
Enumclaw, Washington, 98022
Dylan Fisher, 206-616-2129, dmfb@uw.edu
- Recruiting
Gardenville Dining & Activity Center
Gibsonton, Florida, 33534
Mary Goldsworthy, 813-974-3576, domorefeelbetter@usf.edu
- Active, not recruiting
Edie Windsor SAGE Center
New York, New York, 10001
- Recruiting
Hudson Guild Senior Center
New York, New York, 10011
Victoria Micha Weiss, 915-507-7672
- Recruiting
Lincoln Square Senior Center
New York, New York, 10023
Victoria Micha Weiss, 915-507-7672
- Recruiting
Goddard Riverside Community Center and NORC
New York, New York, 10024
Victoria Micha Weiss, 915-507-7672
- Recruiting
Carver Senior Center
New York, New York, 10029
Victoria Micha Weiss, 915-507-7672
- Recruiting
Dyckman Senior Center
New York, New York, 10034
Victoria Micha Weiss, 915-507-7672
- Active, not recruiting
Stanley M. Isaacs Neighborhood Center
New York, New York, 10128
- Recruiting
SAGE Center Brooklyn at Stonewall House
New York, New York, 11201
Victoria Micha Weiss, 915-507-7672
- Recruiting
Ruskin Senior Center
Ruskin, Florida, 33570
Mary Goldsworthy, 813-974-3576, domorefeelbetter@usf.edu
- Active, not recruiting
Greenwood Senior Center
Seattle, Washington, 98103
- Active, not recruiting
West Seattle Senior Center
Seattle, Washington, 98116
- Active, not recruiting
Southeast Seattle Senior Center
Seattle, Washington, 98118
- Active, not recruiting
GenPride Senior Center
Seattle, Washington, 98122
- Recruiting
Casa Latina
Seattle, Washington, 98144
Bernardo Martinez, 206-616-2129, dmfb@uw.edu
- Recruiting
Centro de la Raza
Seattle, Washington, 98144
Bernardo Martinez, 206-616-2129, dmfb@uw.edu
- Recruiting
Pt Defiance Senior Center
Tacoma, Washington, 98407
Dylan Fisher, 206-616-2129, dmfb@uw.edu
- Recruiting
JL Young Apartments (Senior Housing)
Tampa, Florida, 33604
Mary Goldsworthy, 813-974-3576, domorefeelbetter@usf.edu
- Recruiting
Oaks at Riverview Senior Center
Tampa, Florida, 33604
Mary Goldsworthy, 813-974-3576, domorefeelbetter@usf.edu
- Recruiting
Jewish Towers Senior Housing
Tampa, Florida, 33609
Melody Espinosa, 813-396-2758, domorefeelbetter@usf.edu
- Recruiting
Town 'n Country Senior Center
Tampa, Florida, 33615
Melody Espinosa, 813-396-2758, domorefeelbetter@usf.edu
- Recruiting
Progress Village Senior Center
Tampa, Florida, 33619
Mary Goldsworthy, 813-974-3576, domorefeelbetter@usf.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- Volunteer-delivered Behavioral Activation, Master's level clinician-delivered Behavioral Activation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteer-delivered Behavioral ActivationBehavioural
Behavioral Activation as delivered by trained volunteers
Master's level clinician-delivered Behavioral ActivationBehavioural
Behavioral Activation as delivered by trained master's level clinicians
| Study group | Role | What they receive |
|---|---|---|
| Volunteer-delivered Behavioral Activation - "Do More, Feel Better" | Experimental | "Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients. Receives: Behavioral: Volunteer-delivered Behavioral Activation |
| Master's Level Clinician-delivered Behavioral Activation | Active comparator | Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians Receives: Behavioral: Master's level clinician-delivered Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D)
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.
Measured: Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts
Behavioral Activation Scale (BADS)
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.
Measured: Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts
Secondary outcomes (2)
World Health Organization Disability Assessment Schedule (WHODAS II)
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.
Measured: Change from Baseline WHODAS-II at 3, 6, 9, 24, and 36 weeks after treatment starts
Client Satisfaction with Treatment (CSQ)- 3 Item
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.
Measured: Administered at 3, 6, and 9 weeks after treatment starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start27 Jan 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of South Florida, Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Patrick Raue, University of Washington
- Investigators
- Patrick J Raue, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621877
- Sponsor's protocol ID
- STUDY00011434
- Other IDs
- R01MH124975
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will deposit participant data into the NIMH informatics infrastructure (e.g., National Data Archive) to enable sharing of clinical research data.
Publications
Raue PJ, Sirey JA, Gum A, Hawrilenko M, Fisher DM. Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres. BMJ Open. 2022 Aug 23;12(8):e066497. doi: 10.1136/bmjopen-2022-066497.
PubMed 35998966
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay-Delivered Behavioral Activation in Senior Centers
- ClinicalTrials.gov ID
- NCT04621877
- Acronym / sponsor ID
- STUDY00011434
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of South Florida, Weill Medical College of Cornell University
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteer-delivered Behavioral Activation - "Do More, Feel Better" | Experimental | Behavioral: Volunteer-delivered Behavioral Activation"Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients. |
| Master's Level Clinician-delivered Behavioral Activation | Active comparator | Behavioral: Master's level clinician-delivered Behavioral ActivationTraditional Behavioral Activation (BA) delivered by master's level mental health clinicians |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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.
- Clinically-assessed HAM-D>14
- Mini-Mental Status Exam (MMSE) ≥ 24 OR modified Telephone Interview for Cognitive Status (mTICS) ≥ 19
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volunteer-delivered Behavioral ActivationBehavioral Activation as delivered by trained volunteers | Behavioural | Volunteer-delivered Behavioral Activation - "Do More, Feel Better" |
| Master's level clinician-delivered Behavioral ActivationBehavioral Activation as delivered by trained master's level clinicians | Behavioural | Master's Level Clinician-delivered Behavioral Activation |
Primary outcome
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.
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.
2 secondary outcomes
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
Client Satisfaction with Treatment (CSQ)- 3 Item
Time frame: Administered at 3, 6, and 9 weeks after treatment starts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 35998966Raue PJ, Sirey JA, Gum A, Hawrilenko M, Fisher DM. Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres. BMJ Open. 2022 Aug 23;12(8):e066497. doi: 10.1136/bmjopen-2022-066497.
- Individual participant dataSharing planned: Yes. We will deposit participant data into the NIMH informatics infrastructure (e.g., National Data Archive) to enable sharing of clinical research data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J Raue, PhD principal investigator
University of Washington
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer-delivered Behavioral Activation and Master's level clinician-delivered Behavioral Activation in people with Depression, run by University of Washington at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brittany Mosser (206-616-2129, dmfb@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.