Behavioral Activation for Depression

Overseen By Christian Nelson, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antidepressants

Disqualifiers: Suicidal ideation, Major psychotic disorder, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether behavioral activation (BA) therapy can be delivered via phone or video call to treat depression in older adult cancer survivors. The goal is to determine if this remote therapy effectively improves their mental health. Participants will receive either BA or supportive psychotherapy to compare outcomes. This trial suits older adults who have survived cancer, are currently disease-free, and can communicate in English via phone or video. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently taking antidepressant medication for less than 3 months, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Behavioral Activation (BA) is generally safe for treating depression. Studies have found that BA effectively helps some people overcome depression. Importantly, it improves depressive symptoms without causing serious side effects, with most individuals experiencing few negative effects. BA is a type of therapy that encourages engaging in activities that boost mood and has proven successful for many with depression. Joining this trial could provide an opportunity to try a method that has been safe and effective for many others. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Behavioral Activation is unique because it focuses on helping individuals engage in meaningful activities, which can directly improve mood and reduce depression symptoms. Traditional treatments for depression, like antidepressant medications and cognitive-behavioral therapy, often target chemical imbalances or thought patterns. However, Behavioral Activation emphasizes changing behavior as a way to improve emotional health, particularly benefiting older adult cancer survivors who may face unique challenges. Researchers are excited about this approach because it is action-oriented and may provide a more immediate sense of accomplishment and mood enhancement compared to other therapies.

What evidence suggests that this trial's treatments could be effective for depression in older adult cancer survivors?

Research has shown that Behavioral Activation (BA), one of the treatments in this trial, effectively reduces depression symptoms. A recent review of 28 studies found significant improvement in depression, with a strong effect. Other research indicates that BA can also alleviate anxiety and negative thoughts, such as repetitive, negative thinking. Additionally, online BA programs have shown promise in reducing depression in just two weeks. These findings suggest that BA could be a viable option for treating depression, even in older adults who have survived cancer. Meanwhile, another group in this trial will receive Supportive Psychotherapy (SP), which is also being evaluated for its effectiveness in this population. ^{6 7 8 9 10}

Who Is on the Research Team?

Rebecca Saracino, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for older adults (65+) who have survived cancer, are experiencing mild to moderate depression, and can communicate via phone or video. They must be fluent in English and not require a higher level of psychiatric care. Those with major untreated psychotic disorders or recent changes in antidepressant medication use are excluded.

Inclusion Criteria

Able to communicate over video-conference and/or phone for sessions

I am 65 years old or older.

Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N/A for Training Case participants)

Exclusion Criteria

Current untreated major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder)

I have difficulty making decisions due to my health condition.

I have been on antidepressants for less than 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Behavioral Activation or Supportive Psychotherapy intervention remotely

8 weeks

Remote sessions via telephone or videoconference

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation
• Supportive Psychotherapy

Trial Overview The study tests if behavioral activation therapy, delivered remotely through telephone or videoconference, helps reduce depression in older adult cancer survivors compared to supportive psychotherapy.

How Is the Trial Designed?

Group I: Older Adult Cancer Survivors (OACS) - Supportive Psychotherapy (SP) Experimental Treatment 1 Intervention

Older adult cancer survivors (OACS) will receive a Supportive Psychotherapy intervention

Group II: Older Adult Cancer Survivors (OACS) - Behavioral Activation (BA) Experimental Treatment 1 Intervention

Older adult cancer survivors (OACS) will receive a Behavioral Activation intervention

Behavioral Activation is already approved in United States, China, European Union for the following indications:

Approved in United States as Behavioral Activation Therapy for:

• Depression
• Anxiety in older adults undergoing cardiac procedures

Approved in China as Behavioral Activation Therapy for:

• Loneliness in older adults
• Depression

Approved in European Union as Behavioral Activation Therapy for:

• Depression
• Anxiety

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

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 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]

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]

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]

A study involving 128 participants with major depressive episodes found that a Health Action Process Approach (HAPA)-based internet-delivered behavioral activation intervention significantly reduced clinician-rated depressive symptoms compared to a control group, with a strong effect size at 8 weeks (d = 0.79).

The intervention group also showed improvements in self-rated depressive symptoms, behavioral activation, and various motivational and volitional outcomes, indicating that the HAPA framework effectively enhances treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Web-Based Behavioral Activation Intervention on Depressive Symptoms, Activation, Motivation, and Volition: Results of a Randomized Controlled Trial. Mueller-Weinitschke, C., Bengel, J., Baumeister, H., et al.[2023]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

Behavioral activation (BA) is an effective treatment for depression that focuses on increasing positive reinforcement in the environment to promote healthy behaviors and reduce avoidance.

BA can be integrated with other cognitive-behavioral strategies, making it versatile for various clinical populations and settings, highlighting its potential for broader application in treating emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. Farchione, TJ., Boswell, JF., Wilner, JG.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618157/

Is behavioural activation an effective treatment for ... A meta-analysis of 4 RCTs (n = 156) showed that BA has a small effect of 0.24 (Hedge's adjusted g) in reducing depression symptoms compared to a ...

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/pii/S0005796723002036

Effectiveness of behavioral activation and mindfulness in ... Two-week online behavioral activation and mindfulness reduce depression. Potential maintaining factors, such as reward sensitivity and anhedonia, were improved.

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

Individual behavioral activation in the treatment of depression The largest, most recent meta-analysis included 28 trials and found a pooled effect size (Hedges' g) of 0.83 on depression, 0.37 on anxiety, and 0.64 on ...

5. thejcn.com thejcn.com/DOIx.php?id=10.3988/jcn.2024.0148

Behavioral Activation and Brain Network Changes in ... 3 These findings suggest that BA treatment is at least as effective in improving acute depressive symptoms and preventing relapse as the ...

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

Efficacy and safety of behavioural activation on depression ... Six studies rated as low risk of bias. For short-term follow-ups (up to 6 months), meta-analysis showed behavioural activation had little effect on depression ...

7. 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 ... Note: Behavioral Activation has been shown in research studies to be effective on its own for some people to overcome depression. However, it is often used ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2589979124000362

Behavioral activation to prevent depression in at-risk ... Evidence suggests BA can be effective as a standalone treatment for adult depression (Ekers et al., 2014, Dimidjian et al., 2006).

9. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00596-z

Feasibility of behavioral activation group therapy in reducing ... Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression.

10. 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 ...