DepressionNCT03371771
Volunteer-Delivery of Behavioral Activation
A study testing Volunteer-delivered Behavioral Activation and MSW-delivered Behavioral Activation in people with Depression, run by University of Washington at 4 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 a Behavioral Activation intervention to match the skill set of age-matched lay volunteers available to senior centers (Volunteer BA). 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 MSW-delivered Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Sep 2017to 30 Sep 2020
- 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 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Greenwood Senior Center
Seattle, Washington, 98103
Wallingford Senior Center
Seattle, Washington, 98103
Southeast Senior Center
Seattle, Washington, 98118
Central Area Senior Center
Seattle, Washington, 98144
About this study
Official title: Volunteer-Delivery of Behavioral Activation for Senior Center Clients
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Volunteer-delivered Behavioral Activation, MSW-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
MSW-delivered Behavioral ActivationBehavioural
Behavioral Activation as delivered by trained MSWs
| Study group | Role | What they receive |
|---|---|---|
| Volunteer-delivered Behavioral Activation | Experimental | Not described Receives: Behavioral: Volunteer-delivered Behavioral Activation |
| MSW-delivered Behavioral Activation | Active comparator | Not described Receives: Behavioral: MSW-delivered Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start15 Sep 2017
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants will be randomized to receive either Volunteer or MSW-delivered Behavioral Activation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- 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
- NCT03371771
- Sponsor's protocol ID
- STUDY00002543
- Other IDs
- R34MH111849
- Status last verified
- Oct 2020
- First submitted
- 8 Dec 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volunteer-Delivery of Behavioral Activation for Senior Center Clients
- ClinicalTrials.gov ID
- NCT03371771
- Acronym / sponsor ID
- STUDY00002543
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 13 Dec 2017 (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 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either Volunteer or MSW-delivered Behavioral Activation
| Arm | Type | Receives |
|---|---|---|
| Volunteer-delivered Behavioral Activation | Experimental | Behavioral: Volunteer-delivered Behavioral Activation |
| MSW-delivered Behavioral Activation | Active comparator | Behavioral: MSW-delivered Behavioral Activation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 60 years.
- Attends one of 4 participating Seattle senior centers.
- PHQ-9 score of ≥10 via routine screening.
- Mini Mental State Exam (MMSE) ≥ 24.
- Capacity to provide written consent for both research assessment and the BA intervention.
Key exclusion criteria (4 listed)
- 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.
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 |
| MSW-delivered Behavioral ActivationBehavioral Activation as delivered by trained MSWs | Behavioural | MSW-delivered Behavioral Activation |
Primary outcome
Change from Baseline in Behavioral Activation for Depression Scale (BADS) scores
Time frame: 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
Change from Baseline in Hamilton Rating Scale for Depression (HAM-D) scores
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: No
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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
4 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 MSW-delivered Behavioral Activation in people with Depression, run by University of Washington at 4 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Behavioral Activation for Depression Scale (BADS) scores (time frame: Baseline and 9 weeks). 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?
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 26 Oct 2020.