Do More, Feel Better - Behavioral Activation for Depression

Recruiting at 15 trial locations

Overseen By Nicole O. Crawford

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Suicidal ideation, Psychiatric diagnoses, Severe illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help older adults with depression using a simplified version of Behavioral Activation, a type of therapy. The treatment encourages participants to engage in more enjoyable daily activities, which can reduce feelings of sadness. The study compares the effectiveness of this approach when delivered by trained volunteers versus professional clinicians. It suits seniors who have been feeling down and attend participating senior centers in Seattle, NYC, or Tampa. Participants should not have severe medical conditions or other psychiatric issues. As an unphased trial, this study offers seniors a unique opportunity to contribute to innovative research that could improve mental health care.

Will I have to stop taking my current medications?

The trial requires that participants either be off antidepressants or on a stable dose for 12 weeks before joining. If you're on antidepressants, you don't need to stop them, but you must have been on the same dose for at least 12 weeks.

What prior data suggests that this protocol is safe for senior center clients with depression?

Studies have shown that the "Do More, Feel Better" (DMFB) program is easy for participants to handle. In one initial study, 56 older adults either participated in the DMFB program or received assistance from social workers to become more active. Both groups experienced similar improvements in their depression symptoms. Another study found that older adults in care homes considered DMFB practical and acceptable. These findings suggest the program is safe for seniors, with no reports of serious side effects. DMFB aims to help older adults engage in positive daily activities to improve their mood. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for depression because they explore innovative ways to deliver Behavioral Activation (BA), a proven therapy. The "Do More, Feel Better" program is unique because it simplifies BA so that trained lay volunteers, rather than mental health professionals, can deliver it. This approach has the potential to make effective depression treatment more accessible and affordable for seniors who might face barriers to traditional therapy. Meanwhile, the master's level clinician-delivered BA continues to provide a traditional, professional approach, allowing researchers to compare its effectiveness against the volunteer-delivered method. Both strategies aim to improve mental health care accessibility, particularly for older adults.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that the "Do More, Feel Better" program, which participants in this trial may receive, is led by volunteers and can help reduce symptoms of depression. One study found that participants in this program experienced an 8-point drop in their depression scores over 12 weeks. Another study demonstrated that "Do More, Feel Better" was as effective as the traditional method of Behavioral Activation provided by master's level clinicians, which is another treatment arm in this trial. Behavioral Activation encourages people to engage in activities they enjoy, which can lift their mood and reduce depression. This volunteer-led approach could make it easier to support more people in need. ^{1 2 3 4 6}

Who Is on the Research Team?

Patrick J Raue, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for English-speaking seniors aged 60+ with mild cognitive function (MMSE ≥ 24 or mTICS ≥ 19) and depression (PHQ-9 score of ≥10, HAM-D>14). They must attend a participating senior center in Seattle, NYC, or Tampa. Volunteers need to be stable if on antidepressants. Exclusions include severe medical illness, active suicidal thoughts, substance abuse issues, and certain psychiatric diagnoses.

Inclusion Criteria

You have a PHQ-9 score of ≥10.

Clinically-assessed HAM-D>14

I have not been on antidepressants or have been on a stable dose for 12 weeks.

Exclusion Criteria

I do not have a severe illness like end-stage organ failure.

I have been diagnosed with either major depression or generalized anxiety, but no other psychiatric conditions.

Are you currently receiving therapy for your mood?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Activation therapy delivered by either lay volunteers or master's level clinicians to reduce depressive symptoms

9 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in depression severity and activity levels

36 weeks

Assessments at 3, 6, 9, 24, and 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Master's level clinician-delivered Behavioral Activation
• Volunteer-delivered Behavioral Activation

Trial Overview The study tests whether Behavioral Activation therapy for depression can be effectively delivered by trained volunteers compared to master's level clinicians. The goal is to see if this approach reduces depressive symptoms in elderly clients by encouraging engagement in rewarding activities.

How Is the Trial Designed?

Group I: Volunteer-delivered Behavioral Activation - "Do More, Feel Better" Experimental Treatment 1 Intervention

"Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients.

Group II: Master's Level Clinician-delivered Behavioral Activation Active Control 1 Intervention

Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians

Master's level clinician-delivered Behavioral Activation is already approved in United States for the following indications:

Approved in United States as Behavioral Activation for:

• Depression

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Published Research Related to This Trial

The study is testing a new Behavioural Activation intervention called 'Do More, Feel Better' (DMFB), delivered by older adult volunteers, against clinician-delivered behavioural activation in 288 senior centre clients aged 60 and older, aiming to improve activity levels and reduce depressive symptoms.

This trial is significant as it explores the effectiveness of lay health providers in delivering mental health interventions, potentially increasing access to treatment for depression among older adults in diverse communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres. Raue, PJ., Sirey, JA., Gum, A., et al.[2023]

The 'Do More, Feel Better' intervention can be effectively delivered by trained lay volunteers, with 64% of volunteers successfully certified, indicating feasibility for community-based mental health support.

While the pilot study did not show significant differences in depression scores between the intervention and control groups, clients receiving the intervention reported an 8-point reduction in depression symptoms, suggesting potential benefits for older adults in managing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lay-delivered behavioral activation for depressed senior center clients: Pilot RCT. Raue, PJ., Sirey, JA., Dawson, A., et al.[2021]

Higher levels of childhood adversity were associated with lower credibility ratings for behavioral activation (BA) treatment, indicating that personal history can influence how individuals perceive treatment options.

Providing research evidence of BA's efficacy significantly increased its credibility ratings, making them comparable to schema therapy (ST), but individuals with a history of childhood adversity still preferred ST, suggesting a need for tailored approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Behavioural Activation Lack Credibility Among Those Who Need It Most? A Comparison of Responses to Rationales for Behavioural Activation and Schema Therapy. Curley, S., Smout, MF., Denson, LA.[2019]

In a 9-week randomized controlled trial involving 78 patients with major depression, the study found that both expected mastery and pleasure from behavioral activation tasks were strongly correlated with improvements in depression severity.

The results suggest that the anticipation of pleasure from planned activities may be more important for the effectiveness of behavioral activation than the actual pleasure experienced, highlighting the role of meaningful engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? Furukawa, TA., Imai, H., Horikoshi, M., et al.[2019]

Behavioral activation (BA) was effective in reducing symptoms of depression in a preliminary study involving 20 older adults over 5 weeks, indicating its potential as a treatment for vulnerable populations.

Interestingly, the specific types or amounts of activities (functional, pleasurable, or social) did not significantly correlate with symptom improvement, suggesting that simply engaging in activities to counter avoidance may be key to the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Amount and Type of Activity Matter in Behavioral Activation? A Preliminary Investigation of the Relationship between Pleasant, Functional, and Social Activities and Outcome. Hershenberg, R., Paulson, D., Gros, DF., et al.[2015]

The pilot randomized control trial demonstrated that the 'Do More, Feel Better' (DMFB) intervention, delivered by trained lay volunteers, is feasible and can significantly improve activity levels and reduce depression severity in older adults, with large effect sizes (d ≥ 1.35 for activity and d ≥ 3.34 for depression).

Both DMFB and traditional Behavioral Activation delivered by social workers showed similar outcomes, indicating that lay volunteers can effectively deliver evidence-based interventions, which may help alleviate the shortage of mental health professionals for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Do More, Feel Better": Pilot RCT of Lay-Delivered Behavioral Activation for Depressed Senior Center Clients. Raue, PJ., Hawrilenko, M., Corey, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9046684/

“Do More, Feel Better”: Pilot RCT of Lay-Delivered ... Fifty-six depressed clients were randomized to receive 9 sessions of DMFB or Behavioral Activation delivered by social workers (MSW BA).

2. sciencedirect.com sciencedirect.com/science/article/pii/S2950386825000139

Older Adult Volunteers' Experiences Delivering a Lay-Led ... We conducted an exploratory process evaluation during our ongoing multi-site RCT to evaluate the effectiveness of Do More, Feel Better (DMFB).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04621877

Lay-Delivered Behavioral Activation in Senior Centers The primary aim tests the effectiveness of DMFB, in comparison to MSW BA, on increasing overall activity level (target) and reducing depression symptoms. The ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6803033/

Lay-Delivered Behavioral Activation for Depressed Senior ... Depressed clients randomized to “Do More, Feel Better” showed an 8 point reduction in HAM-D scores at 12 week follow-up (baseline mean=21.2 (sd=3.7) versus 12 ...

5. ncoa.org ncoa.org/article/easing-older-adult-depression-how-one-program-is-showing-promise/

Easing Older Adult Depression: How One Program ... DMFB was just as effective at reducing depression as Behavioral Activation in a pilot study with 56 older adults in 4 Seattle-area senior ...

6. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00640-y

Volunteer-led behavioural activation to reduce depression in ... This 8-week volunteer-led behavioural activation intervention was found to be feasible and acceptable to depressed aged care residents.