Behavioral Activation for Serious Mental Illness

Overseen By Crystal Slanzi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Disqualifiers: Unable to give consent, legal guardian

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

Compensation: Varies

Number of Visits: 16

52 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 individuals with serious mental illness engage more in activities and their communities. The main goal is to determine if a behavioral activation program (a type of therapy) can encourage participants to engage in more varied activities, increase community involvement, and enhance overall well-being. Individuals diagnosed with a serious mental illness, such as major depression or bipolar disorder, who feel it has impacted their daily life, might be suitable candidates. Participants will attend online sessions weekly for 10 weeks, followed by monthly sessions for an additional three months. As an unphased trial, this study provides a unique opportunity to explore new therapeutic approaches and potentially improve quality of life.

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 prior data suggests that this behavioral activation intervention is safe for people with serious mental illness?

Research has shown that behavioral activation is generally safe and well-tolerated. In one study, only 3.7% of participants in the behavioral activation group experienced increased suicidal thoughts, fewer than those receiving standard care. Another study found that behavioral activation can improve well-being without major issues. These findings suggest that this approach is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Activation for serious mental illness because it offers a new approach through an online platform, making it more accessible than traditional in-person therapy options. Unlike standard treatments like medication or face-to-face cognitive-behavioral therapy, this method empowers individuals to engage in meaningful activities that can improve their mood and overall well-being. Additionally, the inclusion of maintenance sessions helps reinforce positive behavior changes, potentially leading to more lasting benefits.

What evidence suggests that this behavioral activation intervention is effective for serious mental illness?

Research has shown that behavioral activation can help treat depression. In several studies, participants in this therapy experienced noticeable improvements in their depression symptoms. For instance, an online group therapy program with ten sessions led to reduced depression and increased activity. In this trial, all participants will receive an online behavioral intervention for 10 weeks, followed by monthly maintenance sessions for 3 months. Behavioral activation helps individuals understand how their actions affect their feelings and encourages engagement in more positive behaviors. While most research focuses on depression, this approach also appears promising for enhancing overall well-being and involvement in meaningful activities. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Behavior Activation

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.

How Is the Trial Designed?

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+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Published Research Related to This Trial

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) 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]

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]

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) 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]

A randomized trial involving 80 patients with major depressive disorder demonstrated that behavioral activation (BA) is feasible in a community mental health clinic setting, with high attendance rates and homework completion among participants.

The study found that BA techniques were delivered more effectively than treatment as usual, and improvements in BA mechanisms were significantly linked to reductions in depressive symptoms, suggesting BA's potential effectiveness for treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Behavioral Activation for Major Depressive Disorder in a Community Mental Health Setting. Crits-Christoph, P., Goldstein, E., King, C., et al.[2022]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11552036/

Behavioral Activation Therapy for Depression Led by Health ... Overall, these findings support the effectiveness and applicability of behavioral activation therapy in treating depression in older adults.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264713/

Comparing the effectiveness of behavioral activation in ... The results of a Mixed ANOVA analysis revealed that participants who underwent BAGT showed significant improvement in depression, rumination, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005791624000727

An online group behavioral activation therapy for major ... A ten-session online group BAT program significantly reduced depressive symptoms in this pre-post trial. · Online group BAT increased behavioral activation ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/10503307.2023.2197630

Individual behavioral activation in the treatment of depression Behavioral activation (BA) is an extensively examined treatment for depression which is relatively simple to apply in comparison to other psychotherapies.

5. medicine.umich.edu medicine.umich.edu/sites/default/files/content/downloads/Behavioral-Activation-for-Depression.pdf

Behavioral activation is one of the most important CBT ... Behavioral activation helps us understand how behaviors influence emotions, just like cognitive work helps us understand the connection between thoughts and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021889/

Efficacy and safety of behavioural activation on depression ... Increased suicidal ideation affected 3.7% of the behavioural activation group and 7.4% of the enhanced usual care group. Unexpected physical health-related ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2882847/

Behavioral activation interventions for well-being: A meta- ... These results provide evidence that BA interventions can increase the well-being of recipients and that they are equally effective regardless of depression ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2950004423000044

A randomized clinical trial of behavioral activation and ... Compared to EXP, BA yielded more rapid declines in anxiety and depression scores during therapy (d=0.75–0.77), as well as lower anxiety and depression scores (d ...

9. withpower.com withpower.com/trial/phase-schizoaffective-disorders-1-2024-59d17

Behavioral Activation for Serious Mental Illness The goal of this study is to evaluate the effectiveness of an behavioral activation intervention to increase meaningful activity and community participation ...