A Digital Mindfulness-Based Program for OCD

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnidade Local de Saúde de Coimbra, EPE

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness-based cognitive-behavioral therapy digital program

    Behavioral

    A digitally-delivered mindfulness-based cognitive-behavioral program, specifically designed for Obsessive-Compulsive Disorder. The program includes 9 weeks, 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). ELIMINAR ESTA DESCRIÇÃO ACIMA, PARA NÃO FICAR REPETIDO?

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Interventional GroupExperimental treatment 1 intervention
Group B: Control Group (CRT)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in severity of obsessive-compulsive symptoms (Y-BOCS-II)

This outcome is assessed using the gold-standard Yale-Brown obsessive-compulsive scale-second edition (Y-BOCS-II).It is a clinician-administered scale comprising 10 items (five assessing obsessions, five assessing compulsions), each rated from 0 to 5. Subscale scores range from 0 to 25, yielding a total score range of 0 to 50, with higher scores indicating greater severity of obsessive-compulsive symptoms: non-/sub-clinical (0-14), mild (15-21), moderate (22-34), severe (35-50). Validation in a portuguese cohort (Castro-Rodrigues, Front Psychiatry. 2018) defined a diagnostic threshold: scores ≥13 indicate the presence of obsessive-compulsive symptomatology consistent with an OCD diagnosis. Scores below this value suggest the absence of clinically significant OCD.

Time frame
To be administered once a week, throughout the 9 weeks of intervention (baseline until week 9).

Secondary outcomes

1

Change in well-being status (WHO-5 Well-Being Index)

This outcome is assessed using a PROM (self-report instrument Patient Reported Outcome Measure) comprising 5 items, each rated on a 6-point scale from 0 ("at no time") to 5 ("all of the time"), over the preceding two weeks. The raw score, obtained by summing the 5 items, ranges from 0 to 25 and is then multiplied by 4 to yield a percentage score ranging from 0 to 100, with higher scores indicating better well-being. A cut-off under 50 is usually indicative of depression.

Time frame
To be administered at baseline, at mid-intervention (week 4 out of 9), and at end of study (week 9).
2

Change in functionality/disability status (WHODAS 2.0)

This outcome is assessed using a PROM (self-report instrument, Patient-Reported Outcome Measure) through the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0), based on the World Health Organization's International Classification of Functioning, Disability and Health (ICF) model. It is a 36-item instrument that assesses functioning and disability across six life domains: cognition, mobility, self-care, getting along with others, life activities, and participation. Each item is rated on a 5-point scale from 0 ("no difficulty") to 4 ("extreme difficulty/cannot do"). Using simple scoring, item scores are summed to produce a total score ranging from 36 to 180, as well as domain-specific scores, with higher scores indicating greater functional impairment/disability.

Time frame
To be administered at baseline and week 9 (end of study).
3

Change in Patient Perception of Patient Centeredness Questionaire (PPPC)

This outcome is assessed using the Patient Perception of Patient Centeredness Questionaire (PCCP), a self-report instrument PROM originally developed by Moira Stewart and colleagues and culturally adapted and validated into European Portuguese, designed to assess the patient's perception of person-centered care received during a clinical consultation. The questionnaire evaluates three core dimensions of the person-centered clinical method: exploring the patient's health, illness, and experience of illness; understanding the whole person; and finding common ground regarding management. Items are rated on a Likert-type scale. We will use the Portuguese version of the questionnaire (Macedo et al., 2019), which showed good psychometric properties.

Time frame
Baseline and end of study (week 9).
4

Feasibility and Engagement metrics (DWAI)

Feasibility will be assessed through initial adherence and retention, engagement (number of daily/weekly/total hours of platform use, number of materials consumed per week/in total, consistency of use), and explanatory factors (facilitators and barriers to adherence). These variables will be assessed using platform-collected data (adherence and engagement metrics) and individual interviews with participants. Exclusive to the intervention group.

Time frame
During the study, and at week 9 (end of study; interviews).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unidade Local de Saúde de Coimbra, EPE

Lead sponsor

University of Coimbra

Collaborator

Coimbra Institute for Clinical and Biomedical Research

Collaborator

Institute of Psychological Medicine (IPM) of the Faculty of Medicine

Collaborator

CIBIT - Coimbra Institute for Biomedical Imaging and Translational Research

Collaborator

This trial is not recruiting at the moment. You can still explore other options: