Cognitive Behavioral Immersion for Depression

Overseen By Iony D Ezawa, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: High suicide risk

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

Compensation: Varies

Number of Visits: 15

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new cognitive-behavioral skills training program, Cognitive Behavioral Immersion (CBI), for individuals experiencing depression. The program will be delivered either through virtual reality or on a flat-screen device like a computer. Participants will be divided into three groups: one using virtual reality, one using a flat-screen, and one with no immediate access to the program. Individuals dealing with depression who can participate in virtual activities may be a good fit for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment methods for depression.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but please confirm with the trial coordinators.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cognitive-behavioral skills training program is safe for individuals with depression?

In a previous study, researchers found that using virtual reality for cognitive behavioral therapy significantly reduced depression scores. This finding suggests that virtual reality therapy might be safe and well-tolerated by participants, with no major safety differences between the virtual reality group and those receiving traditional therapy.

For the flat-screen version of the therapy, studies suggest that this approach can improve both depression and anxiety symptoms. This indicates that the treatment could be safe when delivered through flat screens, such as computers.

Both versions of the therapy have demonstrated positive results in alleviating depression. They appear to be safe and manageable for study participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Immersion (CBI) for depression because it offers a fresh approach to treating this condition. Unlike traditional therapies that involve face-to-face sessions, CBI utilizes virtual reality and flat-screen technology to deliver therapy, making it more accessible and engaging. By learning cognitive-behavioral skills in a virtual environment, participants can practice and apply these strategies in a supportive, interactive setting, enhancing the therapeutic experience. This innovative method not only aims to make therapy more appealing but also potentially more effective by fostering a sense of community among participants.

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

Research has shown that Cognitive Behavioral Immersion (CBI) can improve symptoms of depression and anxiety. In this trial, participants will receive CBI through different methods. One group will experience CBI using virtual reality, which might enhance improvements by creating a more engaging experience. Studies have found that virtual reality in therapy helps people feel more involved and supported. Another group will receive CBI delivered through regular screens, like computers, which also shows promise for reducing depression symptoms. Early evidence suggests that both virtual reality and computer-based CBI could effectively improve mental health. ^{1 2 3 4 6}

Who Is on the Research Team?

Iony D Ezawa, PhD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for individuals with depression or anxiety. Participants must complete initial screenings and evaluations to join. They will be divided into three groups: one using virtual reality, another using flat-screen devices like computers for CBI sessions, and a control group without any intervention for the first 8 weeks.

Inclusion Criteria

Proficient in reading and speaking English

Have a computer with a stable internet connection

Score at or above the clinical threshold on the Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001)

Exclusion Criteria

Sufficiently elevated levels of negative thoughts such that the individual is considered at high risk of harm, according to the Columbia Suicide Severity Rating Scale (CSSRS)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive cognitive-behavioral skills training through virtual reality or flat-screen devices over 8 weekly 1-hour sessions

8 weeks

8 visits (virtual)

Follow-up

Participants complete brief monthly follow-up surveys for 6 months to monitor safety and effectiveness

6 months

6 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Immersion

Trial Overview The study tests a cognitive-behavioral skills training program (CBI) in the metaverse to see if it helps with depression or anxiety. It compares the effectiveness of CBI delivered via virtual reality versus flat-screen devices against no treatment over an 8-week period followed by a 6-month follow-up.

How Is the Trial Designed?

Group I: CBI-Virtual Reality Active Control 1 Intervention

Over 8 weekly 1-hour sessions, participants will learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm will access these sessions using a virtual reality headset.

Group II: Delayed-Access Control Active Control 1 Intervention

Participants randomized to this arm will be asked not to attend CBI sessions.

Group III: CBI-Flat Screen Active Control 1 Intervention

Over 8 weekly 1-hour sessions, participants will learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm will access these sessions using a flat-screen device, such as a computer.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Behavioral activation and mindfulness-based cognitive therapy are innovative approaches to treating and preventing depression, with each supported by at least two large-scale randomized clinical trials, indicating their efficacy.

Behavioral activation focuses on increasing engagement with rewarding activities to alleviate depression, while mindfulness-based cognitive therapy aims to prevent relapse by promoting mindful awareness and acceptance, highlighting different mechanisms of action for these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newer variations of cognitive-behavioral therapy: behavioral activation and mindfulness-based cognitive therapy. Dimidjian, S., Davis, KJ.[2021]

Behavioral activation (BA) is an effective standalone psychotherapy for depression, showing comparable efficacy to traditional cognitive-behavioral therapy (CBT) and is recognized as an evidence-based guided self-help intervention.

Further research is needed to understand the neurobiological mechanisms behind BA and to assess the potential for integrating e-mental health applications of BA into China's public healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review of Empirical Literature of Behavioral Activation Treatment for Depression. Wang, X., Feng, Z.[2022]

Cognitive Behavioral Immersion (CBI), a group-based program delivered in the metaverse, significantly improved depression and anxiety symptoms in 127 participants who attended at least two sessions.

Participants using virtual reality head-mounted displays reported lower anxiety symptoms compared to those using flat-screen devices, suggesting that the mode of delivery may enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining Predictors of Depression and Anxiety Symptom Change in Cognitive Behavioral Immersion: Observational Study. Ezawa, ID., Hollon, SD., Robinson, N.[2023]

A four-week treatment program combining cognitive therapy with pharmacotherapy was developed for depressed patients, focusing on both symptom relief and cost-effectiveness.

Results from the first 80 patients showed improvements in symptoms, with assessments made before and after treatment, as well as at a six-month follow-up, indicating the potential long-term benefits of this combined approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of depressed patients: current trends. Combination cognitive group therapy with cognitive adjustment for depressed inpatients]. Konen, A., Simoneau, JF., Hughes, J., et al.[2018]

Integrating Motivational Interviewing (MI) with Brief Behavioral Activation Therapy for Depression (BATD) aims to enhance patient motivation, which is crucial for adherence to treatment assignments.

This combined approach not only maintains the empirical support for BATD but also addresses the common challenge of low adherence by focusing on motivation, potentially leading to better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Motivational Interviewing and Brief Behavioral Activation Therapy: Theoretical and Practical Considerations. Balán, IC., Lejuez, CW., Hoffer, M., et al.[2022]

When cognitive behavioral therapy (CBT) is conducted effectively, the rate of adverse events is very low, comparable to or even lower than that of a placebo, indicating its safety and efficacy.

Many adverse events arise from poor-quality CBT due to therapists' insufficient training, highlighting the importance of regular patient assessments and supervision to ensure high standards in therapy delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. Okmaoto, Y., Jinnin, R., Yoshino, A., et al.[2018]

Cognitive Behavioral Immersion (CBI) showed promising feasibility and potential benefits for individuals recovering from substance use disorders, with 48 participants reporting increased positive affect during sessions.

Qualitative interviews highlighted both the advantages of the program, such as community support and immersion, and areas for improvement, particularly regarding technological usability, suggesting that while CBI is effective, further refinement is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Immersion for Substance Use Disorders: A Feasibility and Pilot Study of a Peer-Based Coaching Program in the Metaverse. Robinson, N., Mahapatra, A., Jean-Baptiste, B., et al.[2023]

In a study involving 2,304 individuals with mild to moderate depression, the sequence of cognitive behavioral therapy (CBT) components—behavioral activation (BA) and cognitive restructuring (CR)—did not significantly affect symptom changes or dropout rates during internet-based interventions.

Both sequences of CBT components resulted in similar outcomes, indicating that therapists can have flexibility in designing interventions without worrying about the order of these specific components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequencing effects of behavioral activation and cognitive restructuring in an Internet-based intervention for depressed adults are negligible: Results from a randomized controlled trial. Brose, A., Heinrich, M., Bohn, J., et al.[2023]

This pilot randomized controlled trial will assess the effectiveness of a culturally adapted online psychological intervention, the SbS-F program, for reducing depressive symptoms among overseas Filipino workers in Macao, comparing it to enhanced care as usual.

The study aims to evaluate not only the primary outcome of depression but also secondary outcomes like anxiety symptoms and overall wellbeing, using validated instruments and a mixed-methods approach to ensure comprehensive data collection and analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital mental health intervention to reduce depressive symptoms among overseas Filipino workers: protocol for a pilot hybrid type 1 effectiveness-implementation randomized controlled trial. Liem, A., Garabiles, MR., Pakingan, KA., et al.[2022]

In a study of 814 participants undergoing a 6-week cognitive-behavioral Internet-based intervention for mild to moderate depression, 8.6% reported experiencing negative effects, highlighting the importance of monitoring these potential issues.

The study identified two main categories of negative effects: participant-related (such as insights and symptoms) and program-related (including issues with the online format and implementation), with a strong working alliance being a key factor in reducing these negative experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative effects in internet-based interventions for depression: A qualitative content analysis. Fenski, F., Rozental, A., Heinrich, M., et al.[2021]

In a study involving 523 outpatients undergoing 12-14 weeks of cognitive therapy (CT), improvements in patients' cognitive therapy skills were linked to reductions in depressive symptoms, suggesting that these skills play a crucial role in treatment efficacy.

The research indicates that while depressive symptoms did not influence the development of cognitive therapy skills, higher skill levels during treatment were associated with better outcomes, highlighting the importance of skill acquisition in managing depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' comprehension and skill usage as a putative mediator of change or an engaged target in cognitive therapy: Preliminary findings. Jarrett, RB., Vittengl, JR., Clark, LA., et al.[2020]

Computer-delivered Cognitive Behavioral Therapies (C-CBT) are effective for treating depression, showing high effectiveness and adherence among self-referred individuals, based on a review of 22 randomized controlled studies.

Therapist support significantly enhances the effectiveness and adherence of C-CBT, particularly for outpatients referred by clinicians, highlighting the importance of integrating some level of guidance in these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. Iakimova, G., Dimitrova, S., Burté, T.[2018]

A naturalistic study involving 102 participants showed that a one-day cognitive-behavioral therapy workshop led to sustained improvements in depression, anxiety, distress, and self-esteem for those with higher depression scores, maintained over a 2-year follow-up.

While the intervention was effective for participants classified as 'depressed' (BDI scores of 14 and above), those with lower scores did not experience significant changes, highlighting the targeted efficacy of the workshops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can the effects of a 1-day CBT psychoeducational workshop on self-confidence be maintained after 2 years? A naturalistic study. Brown, JS., Elliott, SA., Boardman, J., et al.[2022]

In a study of 3,321 patients undergoing person-centered experiential therapy (PCET) for depression, 38.7% showed an early response by improving significantly by the fourth session, which was a strong predictor of overall treatment success.

Patients who experienced an early response were six times more likely to achieve reliable and clinically significant improvement by the end of treatment, highlighting the importance of early indicators in predicting therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early response as a prognostic indicator in person-centered experiential therapy for depression. Duffy, KEM., Simmonds-Buckley, M., Saxon, D., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12093068/

Cognitive Behavioral Immersion for Depression This protocol aims to conduct a randomized controlled trial evaluating the efficacy of immersive CBI accessed via a virtual reality headset (CBI-VR)

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06418997

Cognitive Behavioral Immersion: a Randomized Control ... The intervention may be delivered through virtual reality as well as flat-screen devices, such as a computer, which may also affect CBI's effectiveness. The ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40327374/

Cognitive Behavioral Immersion for Depression - PubMed - NIH This protocol aims to conduct a randomized controlled trial evaluating the efficacy of immersive CBI accessed via a virtual reality headset (CBI-VR)

4. mental.jmir.org mental.jmir.org/2023/1/e42377

Examining Predictors of Depression and Anxiety Symptom ... Participation in CBI is associated with both depression and anxiety symptom improvement. Web-based social support may play an important role in fostering ...

5. ctv.veeva.com ctv.veeva.com/study/cognitive-behavioral-immersion-a-randomized-control-trial-of-peer-based-coaching-in-the-metaverse

Cognitive Behavioral Immersion: a Randomized Control Trial ... One third of the participants will access CBI through virtual reality, one third of the participants will access CBI through a flat-screen ...

6. researchgate.net researchgate.net/publication/391499641_Cognitive_Behavioral_Immersion_for_Depression_Protocol_for_a_Three-Arm_Randomized_Controlled_Trial_of_Peer-Based_Coaching_in_the_Metaverse_Preprint

Cognitive Behavioral Immersion for Depression The primary outcome was self-reported sleep quality (Pittsburgh Sleep Quality Index, PSQI). Secondary outcomes included actigraphy-based sleep measures, ...