Being With OCD: A Digital Mindfulness-Based Cognitive-Behavioral Program for Obsessive-Compulsive Disorder
| Registry | NCT07871344, acronym MBCT-OCD |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 128 (Estimated) |
| Sponsor | Unidade Local de Saúde de Coimbra, EPE (Other); collaborators: University of Coimbra, Coimbra Institute for Clinical and Biomedical Research, Institute of Psychological Medicine (IPM) of the Faculty of Medicine, CIBIT - Coimbra Institute for Biomedical Imaging and Translational Research |
| Conditions | Obsessive-Compulsive Disorder (OCD) |
| Interventions | Mindfulness-based cognitive-behavioral therapy digital program (Behavioral) |
| Dates | start 2027-03-01 (estimated), primary completion 2028-06-30 (estimated), completion 2028-12-31 (estimated), first posted 2026-10-13, last updated 2026-10-13 |
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All trials for Obsessive-Compulsive Disorder (OCD) All trials of Mindfulness-based cognitive-behavioral therapy digital program
Obsessive-Compulsive Disorder (OCD) is a common long-lasting, and disabling condition, affecting 1 in every 25 people in Portugal. People with OCD experience unwanted, repeated thoughts (obsessions) and repetitive behaviors (compulsions) that impair their daily lives and well-being. Even though OCD is common, many people do not get the specialized help they need. On average, it takes about 10 years from when symptoms first appear until someone receives proper treatment. This happens mainly because specialized care is mostly available in central hospitals, which makes it harder for people living outside big cities to get help. This delay is caused by a mix of factors: distance from specialized centers, financial barriers, and the stigma that still surrounds mental illness. These are well-known problems, and they highlight the urgent need for treatment options that are easier to access and can reach more people.
The "Being with OCD" study aims to test whether an online program - combining cognitive-behavioral therapy (a well-established talk therapy approach) with mindfulness techniques - can effectively help people with OCD. Digital tools like websites and phone apps have become a promising way to make mental health care more available, more affordable, and easier to reach for more patients.
Recent research shows that online cognitive-behavioral therapy programs for OCD can meaningfully reduce symptoms, working about as well as in-person therapy - especially when patients get some support from a clinician along the way. That said, these digital tools have not been tested enough in real-world, everyday settings, and few have been developed by actually listening to what patients and healthcare professionals need. This is a problem because it leads to low engagement by patients in these programs. In fact, a common pattern has been observed: people tend to start using digital therapy programs enthusiastically, but usage drops off quickly after the first few weeks - largely because these programs are not designed around what users actually want and need.
At the same time, mindfulness - the practice of paying attention to the present moment without judgment - has become an increasingly valuable tool to cognitive-behavioral therapy for OCD. This combined approach can help reduce excessive worrying/overthinking, increase acceptance of difficult thoughts, and improve emotional control, helping people relate to their intrusive thoughts in a calmer, less reactive way. Among the different types of therapy available, mindfulness-based approaches tend to work particularly well in digital formats, with people sticking with them more and reporting higher satisfaction. For this reason, beyond testing whether our program works, this study will also look at how practical and well-received the program is for users.
We will recruit 128 patients with OCD, split into two groups: a control group, who will continue receiving their usual care, and an intervention group, who will receive the online program in addition to their usual care. The program will be delivered through a website/app (usable on a computer or smartphone) and will run for 9 weeks, offering audio recordings, educational materials, and practical exercises based on cognitive-behavioral therapy and mindfulness. The goal is to help patients change unhelpful thought patterns and behaviors linked to their condition. Throughout the 9 weeks, participants will complete some tests and interviews so the research team can track changes in symptom severity, well-being, day-to-day functioning, and how practical and acceptable the program is to use.
If this online program proves effective and usable, it could help expand access to OCD treatment for people who currently struggle to find care.
Testing whether this kind of program is practical, well-received, and effective is an important step toward developing new mental health care options that are both clinically effective and genuinely accessible.
The primary objective of this study is to evaluate the efficacy of a digital mindfulness-based cognitive-behavioral therapy program in reducing symptoms of Obsessive-Compulsive Disorder. The secondary objectives regarding this digital mindfulness-based cognitive-behavioral therapy program are to evaluate its impact on users' functionality, users' well-being index, as well as its feasibility and acceptability.
This is a prospective, randomized, outcome assessor-blinded study. Participants recruited at ULS de Coimbra and Family Health Unit Fernão Magalhães will be invited to participate, preferably during their psychiatry, psychology, or family medicine appointment. The remaining participants will be recruited by telephone (patients on the waiting list) through flyers disseminated on social media, and will only be enrolled in the study following an in-person evaluation by a psychiatrist, in order to confirm the diagnosis of Obsessive-Compulsive Disorder and all inclusion criteria. All volunteers will be given an explanation of the study's purpose and the main aspects related to informed consent. Volunteers who agree to participate will be asked to access a link via their smartphone or personal computer (https://oblivia.app), where they will be able to register using their e-mail address. On this platform, they will find a mindfulness-based cognitive-behavioral therapy program, specifically designed for Obsessive-Compulsive Disorder and adapted for digital format. Participation in the study lasts 9 weeks (the duration of the intervention program), during which participants will be guided through mindfulness practices (audio recordings), psychoeducational material on strategies for managing their symptoms, and practical tasks (incorporating meditation practices and proactive strategies into their daily routine). The program was developed in accordance with recommendations from the current literature (e.g., Hershfield \& Corboy, 2013; Hawley et al., 2022; Selchen et al., 2020) by the research team, namely Mariana Marques and Frederica Carvalho (Psychologists and Certified Teachers from the Mindfulness-Based Professional Training Institute at the University of California, San Diego, and from the Oxford Mindfulness Foundation, University of Oxford) and Ana Araújo (Psychiatrist, PhD in the field of Obsessive-Compulsive Disorder). Participation in the study does not interfere with usual clinical practice, as it does not require any additional travel or medical procedures beyond those already scheduled as part of standard clinical care. The "Being with OCD" program was designed to be delivered digitally, allowing participants to complete it at home. Should in-person evaluations be required, these will be scheduled according to the participant's usual clinical pathway.
Patients will be randomized into two groups: the intervention group (which will follow standard clinical practice through psychiatry and psychology appointments and will also undergo the mindfulness-based cognitive-behavioral therapy intervention) and the control group, which will follow standard clinical practice alone.
This study follows a 9-week visit schedule (V0 to V9), beginning with a baseline/screening visit and closing with an end-of-study visit at Week 9.
At V0, eligibility and recruitment procedures take place, followed by informed consent and randomization. Participants undergo a clinical psychiatric evaluation. At this visit, the following questionnaires are applied: the Y-BOCS-II, the WHO-5 Well-Being Index, the WHODAS 2.0 and Patient Perception of Patient-Centeredness Questionnaire - assumed here to reflect further baseline clinical/sociodemographic characterization instruments.
Throughout the intervention period, the Y-BOCS-II is administered weekly to monitor changes in obsessive-compulsive symptom severity. At V4 (mid-intervention), the WHO-5 is additionally applied to assess well-being at the midpoint of the program. For the intervention group only, the digital mindfulness-based cognitive-behavioral therapy program is delivered weekly from V1 through V9.
At the final visit, all participants complete the full battery of assessments: the Y-BOCS-II, the WHO-5, the WHODAS 2.0 and Patient Perception of Patient-Centeredness Questionnaire. For the intervention group only, two additional assessments are conducted exclusively at this visit, to overall evaluate the intervention "Being with OCD" mindfulness based therapy: the feasibility assessment (engagement metrics and qualitative interviews via the Digital Working Alliance Inventory DWAI) and the acceptability and viability assessment (self-report questionnaires and individual interviews), respectively.
The use of digital therapies appears to achieve outcomes comparable to in-person psychotherapy, particularly when it involves a restructuring of cognitive-behavioral aspects (i.e., individuals' ways of thinking and acting). However, the widespread adoption and sustained use of digital therapies still face several barriers, including: the scarcity of studies conducted in real clinical settings; the excessive focus of these studies on symptom improvement, with less attention paid to functional level and potential practical benefits; and the limited inclusion of end-users' perspectives (needs and preferences of both patients and clinicians) in the development of this type of solution.
The present study was designed to overcome these current limitations. Additionally, we aim to test the incorporation of mindfulness-based techniques into standard cognitive-behavioral therapy for Obsessive-Compulsive Disorder, given that this third-generation therapy (mindfulness) has already been shown to reduce rumination, increase acceptance, and improve emotional self-regulation in patients with Obsessive-Compulsive Disorder (Selchen, 2020; Hershfield \& Corboy, 2013).
Should our digital program for Obsessive-Compulsive Disorder prove effective, it may become a specialized, low-cost, and highly scalable therapeutic tool, thereby helping to ensure broader access to treatment for this psychiatric condition.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Interventional Group | Experimental | Behavioral: Mindfulness-based cognitive-behavioral therapy digital program | The intervention group will receive Standard Therapy (psychiatry + psychology) in addition to the Study Intervention (a digital mindfulness-based cognitive-behavioral therapy program). Participants will be asked to access a link via their smartphone or personal computer (https://oblivia.app), where they register using their e-mail address. On this platform, they will find a mindfulness-based cognitive-behavioral therapy program, specifically designed for Obsessive-Compulsive Disorder and adapted for digital format. Participation in the study lasts 9 weeks (the duration of the intervention program), during which participants will be guided through mindfulness practices (audio recordings), psychoeducational material on strategies for managing their symptoms, and practical tasks (incorporating meditation practices and proactive strategies into their daily routine). |
| Control Group (CRT) | No intervention | Control Group will receive Standard Therapy alone (psychiatry + psychology). |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Adults (>18 years old) diagnosed with Obsessive-Compulsive Disorder, recruited from the corresponding outpatient clinic of the Psychiatry CRI (Responsibility Center for Integration) at ULS de Coimbra (Coimbra Local Health Unit), preferably from the waiting list, currently in follow-up care, or recruited from the community. Exclusion Criteria: * Low digital literacy or lack of the resources required for participation (smartphone or computer with internet access); history of other severe neuropsychiatric conditions (such as epilepsy, severe traumatic brain injury, cognitive impairment); significant language, vision, or hearing impairments; alcohol, drug, or other substance abuse.