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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to treat depression in cancer survivors. Participants will either use a mobile app called Moodivate, a tool for Behavioral Activation Therapy, or receive depression treatment sessions through telehealth. The goal is to determine which method better helps cancer survivors manage depression. Cancer survivors experiencing symptoms of depression and not currently receiving treatment are well-suited for this trial. As an unphased trial, participants can contribute to innovative research that may enhance mental health care for cancer survivors.

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.

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

Research shows that the Moodivate app, designed to help with depression in cancer survivors, is undergoing testing to ensure safety and effectiveness. The researchers aim to determine if it causes any unwanted effects. Although specific data on side effects is not yet available, similar digital therapy methods have been well-tolerated in past studies, with participants reporting improvements in their depression.

For the telehealth depression treatment, studies indicate that digital behavioral activation (a therapy that encourages more positive activities) can effectively reduce depression symptoms. This approach has been used safely with cancer survivors, and many have experienced significant mood improvements.

Both treatments focus on improving emotional wellness in cancer survivors. Although exact side effect data for Moodivate is not yet available, previous research on similar methods suggests they are generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Moodivate because it offers a unique, tech-savvy approach to helping cancer survivors manage depression. Unlike traditional therapy sessions, Moodivate is a mobile app that empowers users to take charge of their mental health by identifying personal values, planning activities, and tracking their mood daily. This digital method provides a flexible and accessible alternative to in-person therapy, potentially reaching individuals who might otherwise face barriers to care. Moreover, the app's passive monitoring feature helps tailor the level of care to each person's needs, ensuring they receive the appropriate support.

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

Research has shown that both Moodivate and telehealth-delivered Behavioral Activation therapy, studied in this trial, can reduce depression symptoms in cancer survivors. Participants in the Digitally-Enhanced Stepped Care arm will use Moodivate, a mobile app that creates activities based on personal values to boost mood. Early findings suggest that Moodivate users may experience improvements in mood and overall emotional well-being. Meanwhile, participants in the Guideline-Concordant Standard Care arm will receive online sessions for Behavioral Activation therapy, working remotely with a therapist. These sessions have demonstrated significant improvements in depression symptoms and overall mental health for cancer survivors. Both approaches in this trial aim to help cancer survivors manage depression by encouraging positive activities and engagement. ^{1 2 3 4 5}

Who Is on the Research Team?

Jennifer Dahne, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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The purpose of this research study is to evaluate a mobile application (app) for depression treatment called "Moodivate" among cancer survivors.

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Behavioral Activation Therapy for Cancer Survivors with ...

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