Behavioral Activation for Depression After Stroke

(LIVE-WEL Trial)

Overseen By Jennifer Beauchamp, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Moderate depression, Psychotherapy, Bipolar, Dementia, others

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

Compensation: Varies

Number of Visits: 9

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent depression in people who have had a stroke. It uses Behavioral Activation, delivered over the phone by trained counselors, to support stroke survivors with mild signs of depression. The trial seeks participants who experienced their first stroke within the last six months, have mild depression symptoms, and have a low income. Participants must speak and read in English or Spanish and live in a community setting. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mental health support for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) is safe?

Research has shown that Behavioral Activation therapy delivered over the phone or online (Tele-BA) is a safe method for addressing depression after a stroke. Previous studies have found that similar remote treatments, such as cognitive behavioral therapy, are generally well-received, with most participants experiencing no serious side effects.

Specifically, one study found Tele-BA effective for older adults with low income who remain at home. Although the study primarily assessed its effectiveness, the absence of major safety issues reported is encouraging. This suggests that Tele-BA is a safe option for individuals who have had a stroke and are dealing with depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) because it offers a new way to help stroke survivors manage depression from the comfort of their own homes. Unlike traditional therapy, which often requires in-person visits, Tele-BA-S uses telehealth technology, making it more accessible for patients who may have mobility challenges or live in remote areas. This approach also leverages trained lay counselors, which could make mental health support more affordable and widely available. The potential to provide continuous support without the need for travel is a game-changer for improving mental health care after a stroke.

What evidence suggests that Tele-BA-S might be an effective treatment for post-stroke depression?

Research shows that tele-delivered behavioral activation (Tele-BA-S) with trained lay counselors can improve mood and reduce depression symptoms after a stroke. In this trial, some participants will receive Tele-BA-S, which studies have shown to enhance anxiety and depression scores, as measured by the Hospital Anxiety and Depression Scale. Participants in similar programs have reported less emotional distress and fewer healthcare visits. Although evidence on psychological therapies for post-stroke depression is limited, early findings suggest that Tele-BA-S could effectively prevent depression in older, low-income stroke survivors. ^{1 2 4 6 7}

Who Is on the Research Team?

Jennifer Beauchamp, PhD, RN

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for older, low-income stroke survivors who are not currently depressed but show signs that they might become depressed. Participants must have access to a phone or computer for tele-therapy sessions.

Inclusion Criteria

Residing in a community residence

I can speak and read in English or Spanish.

I had my first stroke less than 6 months ago.

Exclusion Criteria

I do not have a high risk of suicide or severe psychiatric illness.

Stroke event unrelated to vascular risk factors (e.g., drug use) or transient ischemic attack

24-item HDRS score > 8 indicating moderate to severe depression

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tele-delivered behavioral activation sessions by trained lay counselors

5 weeks

5 weekly video-conferenced sessions

Booster Sessions

Participants receive monthly follow-up booster calls to reinforce behavioral activation

2 months

2 monthly follow-up booster calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Follow-up assessments at 2, 4, 6, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)

Trial Overview The study tests if therapy over the phone by trained counselors can prevent depression after a stroke. It compares this 'Tele-delivered Behavioral Activation' with the usual care given to stroke patients.

How Is the Trial Designed?

Group I: Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S) Experimental Treatment 1 Intervention

Group II: Treatment as Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study proposes a new screening tool, the HRQOLISP-E, specifically designed to identify post-stroke depression (PSD) in recent stroke survivors, showing strong construct validity and reliability compared to the Hospital Anxiety and Depression Scale (HADS-D).

The HRQOLISP-E demonstrated significant correlations with depression levels, age, and stroke severity, indicating it may be a more effective tool for assessing depression in stroke patients than existing measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposing a new stroke-specific screening tool for depression: Examination of construct validity and reliability. Ojagbemi, A., Owolabi, M., Akinyemi, J., et al.[2022]

A structured, multidisciplinary intervention program for patients with first-ever stroke or transient ischemic attack (TIA) significantly reduced depressive symptoms one year post-stroke, with only 4.7% of patients in the intervention group experiencing depression compared to 13.5% in the control group.

The intervention also led to a statistically significant improvement in anxiety and depression scores, as measured by the Hospital Anxiety and Depression Scale (HADS), indicating that managing vascular risk factors can positively impact emotional well-being after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect on anxiety and depression of a multifactorial risk factor intervention program after stroke and TIA: a randomized controlled trial. Ihle-Hansen, H., Thommessen, B., Fagerland, MW., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7855933/

Acceptability and Effects of Tele-delivered Behavioral ... Ambulatory care visit data showed that almost two-thirds of those aged 65+ with depression diagnosis were prescribed antidepressants, with selective serotonin ...

2. withpower.com withpower.com/trial/phase-sub-threshold-depression-3-2025-bff9a

Behavioral Activation for Depression After Stroke · Info ... The intervention also led to a statistically significant improvement in anxiety and depression scores, as measured by the Hospital Anxiety and Depression Scale ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06864715/behavioral-activation-for-the-prevention-of-post-stroke-depression-in-low-income-older-stroke-survivors?activelyRecruiting=false&page=434&id=164&slug=depression

Behavioral Activation for the PreVention of Post-strokE ... The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors ( ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546312/

Scientific summary - Behavioural activation therapy for ... - NCBI There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression. One-third ...

5. app.trialscreen.org app.trialscreen.org/trials/behavioral-activation-prevention-post-stroke-depression-low-income-older-trial-nct06864715

Behavioral Activation for Post-Stroke Depression Prevention Participants in the Tele-BA-S group may experience a reduction in depressive symptoms, anxiety, emotional distress, and healthcare visits, as well as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11633058/

Psychological interventions for improvement of symptoms ... Our aim is to provide proof-of-concept evidence for the efficacy of telepsychological need-adapted interventions for patients with post-stroke depression.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2770049

Effect of Telehealth Treatment by Lay Counselors vs ... These findings suggest that tele-BA by lay counselors for older adults with low income who are homebound was an effective depression treatment.