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

Trial Summary

What is the purpose of this trial?

This trial tests if regular people can effectively help seniors with depression by encouraging them to engage in enjoyable activities. It focuses on seniors aged 60 and above at senior centers, aiming to see if this approach can improve their mood and reduce depressive symptoms.

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 data supports the effectiveness of the treatment 'Do More, Feel Better' for depression?

Research shows that 'Do More, Feel Better', a treatment delivered by trained volunteers, significantly improves activity levels and reduces depression severity in older adults. Both volunteer-delivered and clinician-delivered versions of the treatment were found to be equally effective, with high satisfaction reported by participants. ^{1 2 3 4 5}

Is lay-delivered Behavioral Activation safe for humans?

Research indicates that lay-delivered Behavioral Activation, such as the 'Do More, Feel Better' program, is generally safe for humans, with high levels of satisfaction reported by participants and no significant safety concerns noted in studies. ^{1 2 3 4 6}

How is the 'Do More, Feel Better' treatment for depression different from other treatments?

The 'Do More, Feel Better' treatment is unique because it uses trained lay volunteers, rather than professional clinicians, to deliver Behavioral Activation therapy, making it more accessible and potentially addressing the shortage of mental health professionals for older adults. ^{1 2 3 4 5}

Research Team

Patrick J Raue, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

"Do More, Feel Better": Pilot RCT of Lay-Delivered Behavioral Activation for Depressed Senior Center Clients. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Lay-delivered behavioral activation for depressed senior center clients: Pilot RCT. [2021]

4. United States 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. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral activation: Is it the expectation or achievement, of mastery or pleasure that contributes to improvement in depression? [2019]

6. United States 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. [2019]