Actively Recruiting
Efficacy and Cost-effectiveness of a Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder: A Randomized Controlled Trial
Led by Karolinska Institutet · Updated on 2026-05-15
108
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a lifestyle intervention aimed at improving health habits and reducing cardiometabolic risk factors in adults with obsessive-compulsive disorder (OCD). This condition is linked to higher risks of heart and metabolic diseases, partly due to unhealthy lifestyle behaviors. This trial is the first randomized controlled study to assess the effectiveness and cost-efficiency of such an intervention for people with OCD. Participants are randomly assigned to one of two groups. The first group receives a 13-week lifestyle program including one personal session to set goals, followed by 12 weekly group sessions combining education on healthy habits and physical exercise. After these sessions, they get access to a digital booster module to maintain changes. The second group receives one individual session with feedback on their health and written advice on healthy lifestyle habits based on national guidelines. During the study, participants will wear accelerometers to measure physical activity, and assessments will take place at the start, after 14 weeks, and at 12 months to track changes in activity, diet, mental health, and cardiometabolic markers. Questionnaires and physical measurements will be used to evaluate outcomes such as stress, sleep, OCD symptoms, quality of life, and various blood tests. Safety and cost-effectiveness will also be monitored throughout the trial period.
CONDITIONS
Brief Title
A Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with obsessive-compulsive disorder (OCD) according to DSM-5 criteria confirmed by psychiatric interview
- Physically inactive, defined as less than 150 minutes of physical activity per week in the last month
- Aged 18 years or older
You will not qualify if you...
- Intellectual disability or severe psychiatric symptoms or suicidal risk interfering with the intervention
- Diagnosis of an eating disorder or substance use disorder
- Pregnant or less than 1 year postpartum
- Myocardial infarction or stroke within the last 6 months
- Severe cardiovascular risk measures or somatic conditions contraindicating participation
- Recent start or change in cardiometabolic medication within 3 months prior to assessment
- Inability to understand or communicate in Swedish
- Inability to consistently attend intervention sessions
- Inability to travel to intervention sessions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 13 weeks
Participants receive either a 13-week lifestyle intervention involving one individual session and 12 weekly group sessions focused on lifestyle education and physical exercise, or one individual session providing medical and lifestyle advice based on baseline evaluation.
1 individual session and 12 weekly group sessions for the lifestyle intervention; or 1 individual session for medical and lifestyle advice
Duration - Up to 12 months after the primary endpoint
Participants are monitored after the intervention to assess maintenance of lifestyle changes and health outcomes, including access to a booster module for those in the lifestyle intervention group.
Follow-up visits at week 14, 3 months, 6 months, and 12 months after the intervention
Trial Site Locations
Total: 1 location
1
OCD-Programmet, Psykiatri Sydväst
Huddinge, Stockholm County, Sweden, 141 57
Actively Recruiting
Research Team
S
Sofia Asplund, MSc
A
Anna Holmberg, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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