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.
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.
12345What 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.
678910Is 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.
611121314Eligibility 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
I am 18 years old or older.
Have a computer with a stable internet connection
+1 more
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)
Participant Groups
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.
3Treatment groups
Active Control
Group I: CBI-Virtual RealityActive Control1 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 ControlActive Control1 Intervention
Participants randomized to this arm will be asked not to attend CBI sessions.
Group III: CBI-Flat ScreenActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Southern CaliforniaLos Angeles, CA
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Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
[Can we do therapy without a therapist? Active components of computer-based CBT for depression]. [2018]Computer-delivered Cognitive Behavioral Therapies (C-CBT) are emerging as therapeutic techniques which contribute to overcome the barriers of health care access in adult populations with depression. The C-CBTs provide CBT techniques in a highly structured format comprising a number of educational lessons, homework, multimedia illustrations and supplementary materials via interactive computer interfaces. Programs are often administrated with a minimal or regular support provided by a clinician or a technician via email, telephone, online forums, or during face-to-face consultations. However, a lot of C-CBT is provided without any therapeutic support. Several reports showed that C-CBTs, both guided or unguided by a therapist, may be reliable and effective for patients with depression, and their use was recommended as part of the first step of the clinical care. The aim of the present qualitative review is to describe the operational format and functioning of five of the most cited unguided C-CBT programs for depression, to analyze their characteristics according to the CBT's principles, and to discuss the results of the randomized clinical trials (RCT) conducted to evaluate its effectiveness, adherence and user's experience.
[Treatment of depressed patients: current trends. Combination cognitive group therapy with cognitive adjustment for depressed inpatients]. [2018]Depressed patients represent a major part of the inpatient population. The following treatment program was developed in order to respond to this problem in a symptom- and cost-effective way. Cognitive therapy was chosen for it's learning aspect and combined with pharmacotherapy. The four-week treatment program is implemented in an open-ended group setting, where daily therapy sessions are associated with various group activities. The pre- and posttreatment and six months follow-up results of the first 80 patients are presented.
Can the effects of a 1-day CBT psychoeducational workshop on self-confidence be maintained after 2 years? A naturalistic study. [2022]The continued high prevalence of depression in the general population has been in part attributed to a reluctance to consult and also to the limited capacity of psychological therapy services. In a previous randomized controlled trial, self-referral day-long workshops, each for 25 people, offering a cognitive-behavioral therapy approach, seemed to be effective at 3-month follow-up [Brown et al., 2004]. In this study, both experimental group participants and waiting list control participants who went on to attend the workshops (n=102) were followed up and 54.9% provided data after 2 years. The dropout mechanism was investigated and random effects models were used for all analyses. This is a naturalistic study that lacked a control group and had a relatively high attrition rate. The results nevertheless suggest that positive changes in depression, anxiety, distress, and self-esteem achieved at 3 months follow-up were largely maintained at 2 years for those who were "depressed" (Beck Depression Inventory [BDI] scores of 14 and above). However, nondepressed (BDI scores below 14) did not show any significant change. The overall results of this naturalistic study indicate that a very brief, intensive, and large-scale intervention can largely maintain its effects for participants with depression over a 2-year period.
Patients' comprehension and skill usage as a putative mediator of change or an engaged target in cognitive therapy: Preliminary findings. [2020]The skills that patients learn in cognitive therapy (CT) and use thereafter may mediate improvement in depression during and after intervention.
Early response as a prognostic indicator in person-centered experiential therapy for depression. [2023]Currently, no reports exist on the phenomenon of early response in humanistic-experiential therapies. This study investigated the prognostic value of early response on posttreatment outcomes in person-centered experiential therapy (PCET) for depression within the English Improving Access to Psychological Therapies program. The design of the study was a retrospective observational cohort study. Routine clinical data were drawn from N = 3,321 patients with depression symptoms. The primary outcome was reliable and clinically significant improvement (RCSI) on the Patient Health Questionnaire-9 (PHQ-9) self-report depression measure at the end of treatment. Early response was operationalized as reliable improvement, defined as a PHQ-9 change score ≥ 6 from baseline to Session 4. Early response was examined as a predictor of RCSI using logistic regression controlling for baseline depression severity. In sensitivity analyses, therapist effects were controlled using multilevel modeling. A total of 38.7% of patients met the criterion for early response. Patients who experienced an early response to treatment were six times more likely to recover at the end of treatment compared to patients who did not have an early response. The early response effect was still evident after accounting for individual variability between therapists. However, a quarter of patients displayed a pattern of eventual response, reaching recovery at end of treatment despite not experiencing an initial improvement early in therapy. Early response to PCET is a reliable predictor of treatment outcome. Different response patterns evidenced in this study indicate that identifying subgroups of patients associated with early and eventual response could support clinical decision-making. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
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]Applying elements of cognitive behavioral therapy (CBT) in internet-based interventions (IBIs) is effective in treating depression. However, CBT-based IBIs differ in which kind of components are applied and the order of their application. Furthermore, it is as yet unknown whether such sequencing matters. Using an IBI for depression, we examined whether the sequence of two major CBT components, behavioral activation (BA) and cognitive restructuring (CR), affect patterns of symptom changes and dropout rates.
[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. [2018]Adverse events of cognitive behavioral therapy (CBT) can be used to identify two types depending on whether or not CBT is practiced appropriately. The results of a randomized control trial (RCT) when CBT is performed effectively show that the rate of adverse events is as low as, or lower than, that on using a pill placebo. Many adverse events are associated with a low quality of CBT caused by inappropriate practice due to therapists' lack of knowledge, skills, and experience. In order to achieve effective CBT for RCT, it is considered important to frequently assess the status of patients before and during CBT sessions, utilize the Cognitive Therapy Rating Scale after the session, and conduct supervision based on audio recordings of the session.
Cognitive Behavioral Immersion for Substance Use Disorders: A Feasibility and Pilot Study of a Peer-Based Coaching Program in the Metaverse. [2023]Introduction: Cognitive Behavioral Immersion (CBI) is a novel cognitive-behavioral skills program delivered by lay coaches in the metaverse through immersive virtual reality technology. Objectives: The objective for this study was to run a feasibility and pilot study of CBI for individuals in recovery from a substance use disorder. Methods: Data from 48 participants were used and program usage was assessed. Participants were asked to complete questionnaires assessing affect, perceived online social support, and group therapy alliance throughout their participation in the program. Structured qualitative interviews were also conducted with a subset of participants (n = 11) to understand the feasibility of the novel program. Results: Participants experienced a significant increase in their positive affect and non-significant decrease in their negative affect during their most recently attended session. Participants also experienced a nonsignificant increase in online social support across their participation in the program. Structured qualitative interviews revealed eight primary themes, including both advantages (community, psychoeducational impact, immersion, comparability with other interventions, coping in the pandemic, and anonymity) and areas of improvement (challenges and technological usability) of the program. Conclusion: This study provides preliminary support for the feasibility and potential effects of CBI and its incorporation of lay coaches to lead cognitive-behavioral skills groups in the metaverse. Future research is encouraged to examine the feasibility and efficacy of this program for a broader array of clinical presentations.
Examining Predictors of Depression and Anxiety Symptom Change in Cognitive Behavioral Immersion: Observational Study. [2023]Depressive and anxiety disorders are the most common mental disorders, and there is a critical need for effective, affordable, and accessible interventions. Cognitive Behavioral Immersion (CBI) is a novel group-based cognitive behavioral skills training program delivered by lay coaches in the metaverse that can be accessed through various modalities including virtual reality (VR) head-mounted displays or flat-screen devices. Combining its ability to offer empirically supported therapy skills in a digital setting that can still facilitate interpersonal variables (eg, working alliance and sense of social support) with the aid of lay coaches, CBI has the potential to help fill this critical need.
Negative effects in internet-based interventions for depression: A qualitative content analysis. [2021]An increasing number of studies is proving the efficacy of Internet-based interventions (IBI) for treating depression. While the focus of most studies is thereby lying on the potential of IBI to alleviate emotional distress and enhance well-being, few studies are investigating possible negative effects that might be encountered by participants. The current study was therefore exploring self-reported negative effects of participants undergoing a cognitive-behavioral IBI targeting mild to moderate depression over 6 weeks. Data from the client pool of a German insurance company (n = 814, 68% female) revealed that 8.6% of the participants reported the experience of negative effects. Qualitative content analysis yielded two broad categories and five subcategories for the nature of participants' experiences of negative effects: participant-related negative effects (insight and symptom) and program-related negative effects (online format, contact, and implementation). By using both, qualitative and quantitative methods, results did not only shed light on the characteristics of negative effects but analyses also found that working alliance was a predictor for the experience of negative effects. Monitoring the occurrences of negative effects as well as working alliance throughout treatment was considered essential to help prevent negative effects and attrition among participants undergoing IBI for depression.
Integrating Motivational Interviewing and Brief Behavioral Activation Therapy: Theoretical and Practical Considerations. [2022]Behavioral Activation and specifically the Brief Behavioral Activation Therapy for Depression (BATD) has a strong record of empirical support but its focus on practical out of session activation-based assignments can lead to poor levels of adherence if efforts to enhance motivation are not prioritized. Towards this end, this manuscript describes the assimilative integration of Motivational Interviewing (MI) and BATD to improve clinical outcomes by integrating MI's focus on building and maintaining motivation to change into BATD. The manuscript provides an overview of MI and BATD, theoretical issue raised in integrating the two approaches, and examples of how this integration results in a nondirective and motivation-focused approach to conducting BATD.
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]The current pilot randomized controlled trial (RCT) protocol will comprehensively describe the implementation of a culturally adapted Filipino version of the World Health Organization Step-by-Step (SbS-F) program, unguided online psychological intervention for people with depression based on behavioral activation, among overseas Filipino workers (OFWs) in Macao (Special Administrative Region). The main objective of this pilot study is to explore the preliminary effectiveness of the SbS-F program to decrease participant-reported depressive symptoms compared to enhanced care as usual (ECAU); and the secondary objectives are to explore the preliminary effectiveness of the SbS-F to decrease participant-reported anxiety symptoms and improve wellbeing, and to evaluate the potential for SbS-F implementation in real-world settings.
Newer variations of cognitive-behavioral therapy: behavioral activation and mindfulness-based cognitive therapy. [2021]Recent innovations in the treatment and prevention of depression that build on the foundation of cognitive-behavioral therapy represent promising directions for clinical practice and research. Specifically, behavioral activation and mindfulness-based cognitive therapy have been a recent focus of attention. Behavioral activation is a brief, structured approach to treating acute depression that seeks to alleviate depression by promoting an individual's contact with sources of reward through increasing activation, improving problem solving, and decreasing avoidance and other barriers to activation. Mindfulness-based cognitive therapy is a brief group intervention that seeks to prevent depressive relapse by promoting mindful attention, acceptance, and skillful action to help individuals interrupt habitual cognitive and affective patterns associated with risk of relapse. Each approach is supported by at least two large-scale, randomized clinical trials; however, many important questions remain. We examine current research on both approaches by addressing the robustness of findings, the extension to novel populations, and the processes by which clinical benefit is achieved.
A Narrative Review of Empirical Literature of Behavioral Activation Treatment for Depression. [2022]Grounded in the profound tradition of behaviorism theory and research, behavioral activation (BA) has become a standalone psychotherapy for depression. It is simple, straightforward, and easy to comprehend, with comparable efficacy to traditional CBT, and has developed into an evidence-based guided self-help intervention. The main work in the theoretical models and treatment manuals, as well as empirical evidence of the effectiveness of BA for (comorbid) depression in primary and medical care setting are introduced. With the rise of the third wave of CBT, therapeutic components across diagnoses will be incorporated into BA (e.g., mindfulness). Extensive studies are required to examine the neurobiological reward mechanism of BA for depression, and to explore the feasibility and necessity of e-mental health BA application into the public healthcare system in China.