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

306 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test a new cognitive-behavioral skills training program (CBI) delivered in the metaverse. Although initial evidence suggested CBI was feasible for individuals experiencing depression or anxiety, CBI's effectiveness compared to no intervention has yet to be determined. 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 study will enroll up to 306 participants with depression. One third of the participants will access CBI through virtual reality, one third of the participants will access CBI through a flat-screen device, and one third of the participants will be asked not to attend CBI sessions for the first 8 weeks of participation of the trial. For both CBI conditions, treatment will be provided over 8 weeks, with a 6-month follow-up period. Enrollment will be ongoing and groups will occur simultaneously. Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. They will then receive 8-weeks of treatment. Participants will complete brief weekly self-report questionnaires throughout their time in the study.

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 data supports the idea that Cognitive Behavioral Immersion for Depression is an effective treatment?

The available research shows that computer-delivered Cognitive Behavioral Therapies (C-CBT), which are similar to Cognitive Behavioral Immersion, can be effective for treating depression. These therapies can be used with or without a therapist and have been recommended as a first step in clinical care. Additionally, a study on a similar approach, a 1-day CBT workshop, found that positive changes in depression and self-esteem were largely maintained over two years for those who were initially depressed. This suggests that Cognitive Behavioral Immersion could also be effective in maintaining long-term improvements in depression. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Cognitive Behavioral Immersion for Depression?

Research on computer-delivered Cognitive Behavioral Therapies (C-CBT) shows they can be effective for depression, even without a therapist's guidance, suggesting that structured, self-guided CBT approaches like Cognitive Behavioral Immersion might also be beneficial. ^{1 2 3 4 5}

What safety data exists for Cognitive Behavioral Immersion (CBI) treatment?

The safety data for Cognitive Behavioral Immersion (CBI) is limited but suggests it is feasible and potentially effective. A pilot study on CBI for substance use disorders indicated positive effects on participants' affect and social support, with no significant negative effects reported. However, challenges related to technological usability were noted. In general, internet-based interventions for depression, which include cognitive-behavioral elements, have reported some negative effects, such as issues with the online format and implementation, but these are often linked to the quality of the intervention delivery. Monitoring and maintaining a strong working alliance are important to minimize negative effects. ^{6 7 8 9 10}

Is Cognitive Behavioral Immersion (CBI) generally safe for humans?

Cognitive Behavioral Immersion (CBI) has been studied for substance use disorders and depression, showing potential benefits with no significant safety concerns reported. However, like other internet-based interventions, some participants may experience negative effects, such as increased symptoms or issues with the online format, which are important to monitor. ^{6 7 8 9 10}

Is Cognitive Behavioral Immersion a promising treatment for depression?

Yes, Cognitive Behavioral Immersion is a promising treatment for depression. It builds on the effective elements of cognitive behavioral therapy, like behavioral activation, which has strong support for helping people with depression. This approach is simple, easy to understand, and has shown similar success to traditional methods in improving mental health. ^{6 11 12 13 14}

How is Cognitive Behavioral Immersion (CBI) treatment for depression different from other treatments?

Cognitive Behavioral Immersion (CBI) is unique because it likely combines elements of cognitive behavioral therapy (CBT) such as behavioral activation and cognitive restructuring, potentially in a novel sequence or format, to enhance treatment effectiveness for depression. This approach may focus on immersive experiences to engage patients more deeply, differing from traditional CBT methods that are often more structured and session-based. ^{6 11 12 13 14}

Research Team

Iony D Ezawa, PhD

Principal Investigator

University of Southern California

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. [2018]

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[Treatment of depressed patients: current trends. Combination cognitive group therapy with cognitive adjustment for depressed inpatients]. [2018]

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Can the effects of a 1-day CBT psychoeducational workshop on self-confidence be maintained after 2 years? A naturalistic study. [2022]

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Patients' comprehension and skill usage as a putative mediator of change or an engaged target in cognitive therapy: Preliminary findings. [2020]

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Early response as a prognostic indicator in person-centered experiential therapy for depression. [2023]

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Sequencing effects of behavioral activation and cognitive restructuring in an Internet-based intervention for depressed adults are negligible: Results from a randomized controlled trial. [2023]

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[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. [2018]

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Cognitive Behavioral Immersion for Substance Use Disorders: A Feasibility and Pilot Study of a Peer-Based Coaching Program in the Metaverse. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Examining Predictors of Depression and Anxiety Symptom Change in Cognitive Behavioral Immersion: Observational Study. [2023]

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Negative effects in internet-based interventions for depression: A qualitative content analysis. [2021]

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

Integrating Motivational Interviewing and Brief Behavioral Activation Therapy: Theoretical and Practical Considerations. [2022]

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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. [2022]

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Newer variations of cognitive-behavioral therapy: behavioral activation and mindfulness-based cognitive therapy. [2021]

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A Narrative Review of Empirical Literature of Behavioral Activation Treatment for Depression. [2022]