Behavioral Activation Therapy for Cancer Survivors with Depression

Overseen By Olivia Levins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Suicidal ideation

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

Compensation: Varies

Number of Visits: 12

Duration: 10 weeks

45 Participants Needed

Trial Summary

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 focuses on depression treatment through a mobile app or telehealth sessions, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment Moodivate, Telehealth Delivered Behavioral Activation for cancer survivors with depression?

Research shows that behavioral activation therapy can lead to significant improvements in depression symptoms for cancer patients, with many experiencing sudden, large gains that are maintained over time. Additionally, cognitive-behavioral therapy, which includes behavioral activation techniques, has been effective in improving depression, anxiety, and quality of life in cancer patients. ^{1 2 3 4 5}

Is Behavioral Activation Therapy safe for cancer survivors with depression?

Behavioral Activation Therapy has been studied in cancer patients and is generally considered safe, with patients showing good compliance and satisfaction. No specific safety concerns were reported in the studies reviewed. ^{2 3 6 7 8}

How is the treatment Moodivate different from other treatments for depression in cancer survivors?

Moodivate, as part of Behavioral Activation Therapy, focuses on encouraging cancer survivors to engage in rewarding activities to improve their mood and quality of life, which is different from other treatments that may focus more on cognitive restructuring or medication. This approach is particularly useful for cancer survivors who may experience depression due to the progressive abandonment of activities. ^{3 9 10 11 12}

What is the purpose of this trial?

The purpose of this research study is to evaluate different depression treatment approaches among cancer survivors. A cancer survivor is defined as anyone who is living and has been diagnosed with cancer. Participants will be randomly assigned to either receive a mobile app for depression treatment, called "Moodivate", or to receive telehealth depression treatment sessions. Approximately 2/3 of participants enrolled will receive the mobile app and the remaining 1/3 will receive depression treatment via telehealth. Participants that receive Moodivate may later be assigned to also receive depression treatment via telehealth based their response to the Moodivate app. Participants will be asked to either use the Moodivate app and/or receive depression treatment via telehealth for a period of 10 weeks. All participants will be asked to electronic questionnaire measures throughout the study period. Questionnaires will assess symptoms of depression, as well as general experiences using Moodivate and participating in this trial. Participation in this study will take about 24 weeks. Participation in this study may help improve options for emotional wellness for cancer survivors. The greatest risks of this study include frustration, worsening of emotional distress, data breach, and/or loss of confidentiality.

Research Team

Jennifer Dahne, MD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for adults over 18 who have survived cancer and are currently experiencing depression (PHQ-9 score ≥ 8), but aren't already getting treatment for it. They must be able to use the Moodivate app, participate in telehealth sessions, have email or text message access, and speak English fluently. Those with current suicidal thoughts are not eligible.

Inclusion Criteria

Cancer survivor

Current elevated depressive symptoms defined per ASCO as a PHQ-9 score ≥ 8

Have the ability to complete treatment via telehealth and use Moodivate

Exclusion Criteria

Current suicidal ideation at final eligibility screening (PHQ-9 item 9 ≥1)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Moodivate app or telehealth depression treatment sessions for 10 weeks

10 weeks

Telehealth sessions as needed

Monitoring

Participants' engagement with the Moodivate app is monitored for two weeks to determine if care needs to be stepped up

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Questionnaire measures at weeks 12, 16, 20, and 24

Treatment Details

Interventions

• Moodivate
• Telehealth Delivered Behavioral Activation

Trial Overview The study compares two depression treatments for cancer survivors: a mobile app called 'Moodivate' versus telehealth sessions. Participants will either use the app or receive online therapy for 10 weeks, with some possibly transitioning from the app to telehealth based on their progress.

Participant Groups

Group I: Digitally-Enhanced Stepped Care Experimental Treatment 1 Intervention

Participants randomized to the Digitally-Enhanced Stepped Care condition will be instructed to utilize a Behavioral Activation therapy focused mobile application called "Moodivate" regularly, at least once per day, for the treatment of depressed mood among cancer survivors. Participants in the Digitally-Enhanced Stepped Care group will receive a download code to download the Moodivate mobile application. Moodivate is a mobile app for individuals with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, and rate mood daily. Participants will be asked to complete questionnaire measures at weeks 12, 16, 20, and 24 post-randomization. App engagement will be passively monitored for two weeks following initial download to determine whether care needs to be stepped up to guideline-concordant standard care.

Group II: Guideline-Concordant Standard Care Active Control 1 Intervention

Participants randomized to the Guideline-Concordant Standard Care condition will receive 8 sessions of telehealth-delivered Behavioral Activation therapy with a mental health provider over a 10 week period. Participants will be asked to complete questionnaire measures at weeks 12, 16, 20, and 24 post-randomization.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of depressed cancer patients undergoing a brief 9-session behavioral activation therapy, 50% experienced significant sudden gains, averaging an improvement of 11.8 points on the BDI-II depression scale, which correlated with better treatment outcomes and sustained benefits at a 3-month follow-up.

Patients who experienced sudden gains tended to have less severe depression and anxiety, better physical functioning, and fewer daily activity problems, suggesting that certain baseline characteristics may influence the likelihood of achieving these gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden gains in depressed cancer patients treated with behavioral activation therapy. Hopko, DR., Robertson, SM., Carvalho, JP.[2009]

In a study of 114 cancer survivors, internet-delivered cognitive behavioral therapy (iCBT) significantly reduced symptoms of anxiety and depression compared to treatment-as-usual, with a large effect size (Hedges g = 1.51).

Participants in the iCBT group also experienced lower general distress, reduced fear of cancer recurrence, and improved quality of life, indicating that this therapy is an effective and efficient option for managing mental health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). Murphy, MJ., Newby, JM., Butow, P., et al.[2020]

This study is the first randomized controlled trial examining the effectiveness of a behavioral activation (BA) program specifically for treating depression in patients with advanced cancer, involving 38 participants across three sites in Japan.

The primary outcome measure is the Beck Depression Inventory-II (BDI-II) score, and the results are expected to provide evidence for BA as a feasible and acceptable intervention to improve mood and quality of life in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial. Hirayama, T., Ogawa, Y., Ogawa, A., et al.[2023]

Behavioral activation (BA) significantly improves the quality of life and emotional well-being of lung and breast cancer patients undergoing chemotherapy, as shown in a study with 50 lung cancer patients and 33 breast cancer patients in the experimental group.

The intervention helps patients maintain rewarding activities, which can enhance their social and role functioning while reducing avoidance behaviors, demonstrating BA as a practical approach during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Behavioral Activation on the Quality of Life and Emotional State of Lung Cancer and Breast Cancer Patients During Chemotherapy Treatment. Fernández-Rodríguez, C., Villoria-Fernández, E., Fernández-García, P., et al.[2020]

Both Behavioral Activation (BA) and Acceptance and Commitment Therapy (ACT) are effective treatments for emotional problems in cancer survivors, as shown in a study of 52 patients, where both therapies outperformed a waiting list control group.

ACT was found to be more effective than BA in reducing social impairment and avoidance/rumination, indicating that these mechanisms play a key role in improving emotional well-being among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating anxiety and depression of cancer survivors: Behavioral activation versus acceptance and commitment therapy. González-Fernández, S., Fernández-Rodríguez, C., Paz-Caballero, MD., et al.[2018]

A retrospective review of 10 cancer patients undergoing behavioral activation therapy (BAT) showed a high completion rate (90%) and significant improvements in depression and anxiety scores, indicating BAT's potential effectiveness in this population.

Patients reported substantial reductions in depression (PHQ-9 scores decreased from 14.4 to 5.1) and anxiety (GAD-7 scores decreased from 11.9 to 4.7) after completing the program, suggesting that BAT can be a valuable non-pharmacological treatment option for managing mental health in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation therapy for depression and anxiety in cancer patients: a case series study. Hirayama, T., Ogawa, Y., Yanai, Y., et al.[2022]

References

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

Making Internet-delivered cognitive behaviour therapy scalable for cancer survivors: a randomized non-inferiority trial of self-guided and technician-guided therapy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Sudden gains in depressed cancer patients treated with behavioral activation therapy. [2009]

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

Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of depression in cancer patients. [2021]

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Psychotropic polypharmacy and its association with health-related quality of life among cancer survivors in the USA: a population-level analysis. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial. [2023]

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

Effects of Behavioral Activation on the Quality of Life and Emotional State of Lung Cancer and Breast Cancer Patients During Chemotherapy Treatment. [2020]

11. Spain pubmed.ncbi.nlm.nih.gov

Treating anxiety and depression of cancer survivors: Behavioral activation versus acceptance and commitment therapy. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Behavioral activation therapy for depression and anxiety in cancer patients: a case series study. [2022]