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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a type of therapy called behavioral activation, which helps people do enjoyable activities to feel better, can be done over the phone or video calls. It focuses on older adults who have survived cancer and are dealing with depression. Behavioral activation is a well-established treatment for depression, recognized for its effectiveness in increasing engagement in enjoyable activities to improve mood.

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.

What data supports the effectiveness of the treatment Behavioral Activation for Depression?

Behavioral Activation (BA) is a well-supported treatment for depression, with research showing that components like activity scheduling and skills training are effective on their own and as part of larger treatment packages. Studies have demonstrated that BA can help increase motivation and reduce depressive symptoms by encouraging engagement in positive activities. ^{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 a safe treatment for depression. ^{1 3 5 6 7}

How is Behavioral Activation treatment for depression different from other treatments?

Behavioral Activation (BA) is unique because it focuses on increasing engagement in positive activities to boost mood and reduce avoidance behaviors, rather than directly targeting negative thoughts like some other therapies. It can be used alone or as part of cognitive-behavioral therapy (CBT) and is adaptable to various settings and populations. ^{1 2 3 5 8}

Research Team

Rebecca Saracino, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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]

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]

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]

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]

References

1. Switzerland 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. [2023]

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

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. [2019]

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

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

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

What is behavioral activation? A review of the empirical literature. [2022]

5. 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]

6. United States 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. [2019]

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

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

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

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