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

280 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).

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 data supports the effectiveness of the treatment Tele-delivered Behavioral Activation by lay counselors after Stroke (Tele-BA-S)?

Research shows that brief psychosocial and behavioral interventions, when combined with antidepressants, can significantly reduce depression in stroke survivors more than usual care. Additionally, technology-based interventions have been effective in reducing depression and improving quality of life for caregivers of stroke survivors, suggesting potential benefits for similar approaches in stroke patients. ^{1 2 3 4 5}

Is Behavioral Activation for Depression After Stroke safe for humans?

The research does not provide specific safety data for Behavioral Activation for Depression After Stroke, but similar psychological treatments like cognitive behavioral therapy (CBT) are generally considered safe for humans. ^{2 3 6 7 8}

How is the Tele-delivered Behavioral Activation treatment for depression after stroke different from other treatments?

Tele-delivered Behavioral Activation (Tele-BA-S) is unique because it uses lay counselors to provide therapy remotely, focusing on engaging patients in activities to improve mood, which is different from traditional drug treatments that primarily rely on medication to manage depression. ^{1 3 9 10 11}

Research Team

Jennifer Beauchamp, PhD, RN

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reducing depression in stroke survivors and their informal caregivers: a randomized clinical trial of a Web-based intervention. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Augmented Cognitive Behavioral Therapy for Poststroke Depressive Symptoms: A Randomized Controlled Trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Brief psychosocial-behavioral intervention with antidepressant reduces poststroke depression significantly more than usual care with antidepressant: living well with stroke: randomized, controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of technology-based interventions on psychological morbidities, quality of life for informal caregivers of stroke survivors: A systematic review and meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Poststroke suicide risk among older adults in South Korea: A retrospective longitudinal cohort study. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

[Post-stroke depression: diagnosis and therapy]. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral psychotherapy for depression following stroke: a randomized controlled trial. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Proposing a new stroke-specific screening tool for depression: Examination of construct validity and reliability. [2022]

10. England 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. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The Post-Stroke Depression Risk Scale (PoStDeRiS): Development of an Acute-Phase Prediction Model for Depression 6 Months After Stroke. [2022]