Behavioral Activation for Serious Mental Illness

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Temple University

Disqualifiers: Unable to give consent, legal guardian

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation for people with serious mental illness. The overall objective of this study is to increase engagement in meaningful activities and community participation. The objectives of the project are as follows: 1. To determine if the intervention leads to increases the frequency and variety of activities. 2. To determine if the intervention leads to increases in community mobility. 3. To determine which demographic and environmental factors and mechanisms of action impact the effectiveness of the intervention. 4. To determine if the the intervention leads to an improvement in overall well-being (e.g., improved quality of life). Participants will be asked to attend a 2-hour weekly online session for 10 weeks and then a 1-hour online monthly session for a 3 month maintenance period. For data collection, participants will also be asked to: 1. Complete three, approximately 1-hour interviews at baseline, after the 10 week intervention, and again at the end of the maintenance period; 2. Carry a mobile phone with a global positioning system app to track their movements outside their home for 2 weeks at a time, at three separate times (e.g., baseline, after the intervention, and at the end of the maintenance period); and 3. Complete a 15 minute weekly interviews for 26 weeks about their daily activities and participation. The study will enroll 52 participants split into 4 cohorts of 13. The study will use a multiple baseline design and, as such, all participants will receive the intervention and there is no control group.

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 seems focused on behavioral interventions, so you may not need to change your medication routine, but it's best to confirm with the study coordinators.

What data supports the effectiveness of the treatment Behavioral Activation for Serious Mental Illness?

Behavioral Activation (BA) is shown to be an effective treatment for depression by increasing engagement in positive activities, which can help improve mood. It has also been explored as a potential intervention for negative symptoms of schizophrenia, suggesting its broader applicability in mental health treatment. ^{1 2 3 4 5}

Is Behavioral Activation safe for humans?

The research articles reviewed do not provide specific safety data for Behavioral Activation, but it is generally considered an evidence-based treatment for depression, suggesting it is safe when used appropriately. ^{1 2 5 6 7}

How is the treatment Behavioral Activation different from other treatments for serious mental illness?

Behavioral Activation is unique because it focuses on increasing engagement in positive activities to improve mood and mental health, rather than directly addressing negative thoughts or feelings. This approach is simple, effective, and can be applied to a wide range of mental health issues, making it a versatile option compared to more complex therapies. ^{1 2 5 6 8}

Research Team

Eligibility Criteria

This trial is for individuals with serious mental illnesses like Schizoaffective Disorder, Schizophrenia, various forms of Depression, Bipolar Disorder, Psychosis, and Mood Disorders. Participants should be willing to engage in online sessions and use a GPS app to track movement.

Inclusion Criteria

Be able to communicate in English

Be available on the day and time (i.e., Monday, Tuesday, Wednesday, Thursday, or Friday) the intervention is scheduled for each cohort

I am over 18 years old.

Exclusion Criteria

I have a legal guardian.

I am unable to understand and give consent for treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend a 2-hour weekly online session for 10 weeks to increase meaningful activity and community participation

10 weeks

10 visits (virtual)

Maintenance

Participants attend a 1-hour online monthly session for a 3-month maintenance period

3 months

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention and maintenance period

4 weeks

3 visits (virtual)

Treatment Details

Interventions

• Behavior Activation (Behavioral Intervention)

Trial Overview The study tests Behavioral Activation intervention aimed at increasing activity variety and community participation among the mentally ill. It involves weekly online sessions for 10 weeks followed by monthly check-ins over three months.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

All participants will receive an online behavioral intervention for 10 weeks, followed by monthly maintenance sessions for 3 months.

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

Dr. Kumar Budur

Temple University

Chief Medical Officer

MD, MS

Dr. Jeffrey M. Dayno

Temple University

Chief Executive Officer

MD from Temple University School of Medicine

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Dr. Kristi Hill

National Institute on Disability, Independent Living, and Rehabilitation Research

Acting Director since 2012

PhD in Neuroscience from the Medical College of Virginia

Dr. Phillip Beatty

National Institute on Disability, Independent Living, and Rehabilitation Research

Director of the Office of Research Sciences since 2019

PhD in Rehabilitation Sciences

Findings from Research

Behavioral activation (BA) is an effective treatment for depression, but many patients still experience treatment failure due to various factors, such as difficulty understanding the treatment rationale and behavioral noncompliance.

A case study of a depressed breast cancer patient highlights these challenges and suggests that improving patient awareness of life values and enhancing contingency management could help reduce failure rates in BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment failure in behavior therapy: focus on behavioral activation for depression. Hopko, DR., Magidson, JF., Lejuez, CW.[2022]

The study found that patients generally had a positive experience with Brief Behavioral Activation Treatment for Depression (BATD) delivered in a group setting, highlighting helpful aspects like motivation, goal setting, and activity scheduling.

Patients provided mixed feedback on certain elements, such as the focus on depression and the balance between lecture and participation, indicating areas for improvement in the group therapy format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient experiences with group behavioural activation in a partial hospital program. Stein, AT., Tian, L., Cuthbert, K., et al.[2021]

Behavioral activation (BA) significantly reduced negative symptoms in patients with schizophrenia when combined with treatment-as-usual (TAU), as shown by improved scores on the Clinical Assessment Interview for Negative Symptoms (CAINS) and other scales in a study of 70 participants.

Although BA showed immediate benefits post-treatment, these improvements were not maintained at the six-month follow-up, indicating the need for further research to understand how to sustain these positive effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based multi-site randomized controlled trial of behavioral activation for patients with negative symptoms of schizophrenia. Oh, J., Lee, E., Cha, EJ., et al.[2023]

Behavioral activation is an effective treatment for depression that focuses on increasing positive activities to counteract negative mental states, making it a fundamental mechanism for change in various psychological disorders.

This approach can be integrated into many forms of psychotherapy, potentially speeding up treatment and improving outcomes across a wide range of mental health issues, from chronic pain to personality disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation as a common mechanism of change across different orientations and disorders. Dimaggio, G., Shahar, G.[2018]

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]

A systematic review of nine randomized controlled trials involving 2157 adult participants found that guided Internet-based behavioral activation (BA) is effective in reducing depression and anxiety, showing promising results compared to other treatments like physical activity and psychoeducation.

While Internet-based BA demonstrated non-inferior efficacy to other behavioral therapies and mindfulness, the overall quality of evidence was low to moderate, indicating a need for more rigorous studies to confirm its effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. Huguet, A., Miller, A., Kisely, S., et al.[2019]

Behavioral activation (BA) is an effective and affordable psychotherapy for major depressive disorder (MDD), focusing on increasing engagement in rewarding activities and reducing avoidant behaviors.

Randomized controlled trials indicate that BA has a strong therapeutic effect on MDD, making it a viable treatment option, although more research is needed to explore its application in other psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Behavioral activation programs: A tool for treating depression efficiently]. Dondé, C., Moirand, R., Carre, A.[2018]

References

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

Treatment failure in behavior therapy: focus on behavioral activation for depression. [2022]

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

Patient experiences with group behavioural activation in a partial hospital program. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Community-based multi-site randomized controlled trial of behavioral activation for patients with negative symptoms of schizophrenia. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Behavioral Activation for Major Depressive Disorder in a Community Mental Health Setting. [2022]

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

Behavioral activation as a common mechanism of change across different orientations and disorders. [2018]

6. 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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the efficacy of Internet-delivered behavioral activation. [2019]

8. France pubmed.ncbi.nlm.nih.gov

[Behavioral activation programs: A tool for treating depression efficiently]. [2018]