Lifestyle program to lower heart and metabolic risk in people with obsessive-compulsive disorder
Efficacy and Cost-effectiveness of a Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder: A Randomized Controlled Trial
This program will test whether a group lifestyle intervention helps adults with OCD become more physically active and lower their cardiometabolic risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Huddinge, Stockholm County) |
| Trial ID | NCT07206212 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will compare a group-based lifestyle intervention to medical and lifestyle advice for adults with OCD who are physically inactive. Physical activity will be measured objectively with accelerometers, and outcomes will include lifestyle habits, physiological and laboratory cardiometabolic measures, mental health, functioning, and quality of life. A health economic analysis will evaluate cost-effectiveness from a healthcare provider perspective. The trial is conducted by Karolinska Institutet at the OCD-Programmet in Huddinge, Sweden.
Who should consider this trial
Good fit: Adults aged 18 or older with a confirmed DSM-5 diagnosis of OCD who are physically inactive (under 150 minutes of activity per week) are the intended participants.
Not a fit: People who already meet recommended physical activity levels, who have medical conditions that prevent exercise, or whose OCD is currently unstable may be unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could increase physical activity, improve cardiometabolic health, and enhance quality of life for people with OCD.
How similar studies have performed: Previous feasibility work found the intervention acceptable and safe, but this is the first randomized trial to test its efficacy and cost-effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. A diagnosis of obsessive-compulsive disorder (OCD), based on the diagnostic criteria of the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders. Screened at registration and at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview), using a semi-structured diagnostic interview. 2. Physical inactivity/sedentarism, operationalized as less than 150 minutes of physical activity per week during the last month, evaluated by asking two questions from the Swedish National Board of Health and Welfare concerning 1) frequency of weekly moderate or vigorous intensity physical exercise and 2) frequency of weekly non-exercise/daily life physical activity. Screened at registration and at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview). 3. Aged 18 years or older. Screened at registration and confirmed by the assessor at the initial phone call and/or confirmed by the assessor at the inclusion assessment (psychiatric interview). Exclusion criteria: 1. Intellectual disability or severe psychiatric symptoms or suicidal risk that could interfere with the intervention. Screened at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview), using a semi-structured diagnostic interview. 2. A diagnosis of an eating disorder or a substance use disorder. Screened at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview), using a semi-structured diagnostic interview. 3. Being pregnant or \<1 year postpartum. Screened at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview). 4. Myocardial infarction or stroke within the last 6 months. Screened at registration and confirmed by the assessor at the initial phone call and/or the inclusion assessment (physiological measures). 5. Cardiovascular risk measures significantly over the normal range (e.g., severe hypertension \[blood pressure above ≥180 mmHg systolic or ≥110 mmHg diastolic\]) or a current somatic condition that make participation in the intervention contraindicated. Screened at registration and confirmed by the assessor at the initial phone call and/or the inclusion assessment (physiological measures), after consulting with the study doctor, if necessary. 6. Initiation or adjustment of any cardiometabolic medication (e.g., blood pressure or blood lipids lowering mediation) within 3 months prior to assessments. Screened at registration and confirmed by the assessor at the initial phone call and/or the inclusion assessment (physiological measures). 7. Inability to understand and communicate in Swedish. Confirmed by the assessor at the initial phone call. 8. Inability to consistently attend the sessions involved in the intervention. Screened by the assessor at the initial phone call and/or confirmed by the assessor at the inclusion assessment (psychiatric interview). 9. Inability to travel to the sessions involved in the intervention. Screened by the assessor at the initial phone call and/or confirmed by the assessor at the inclusion assessment (psychiatric interview).
Where this trial is running
Huddinge, Stockholm County
- OCD-Programmet, Psykiatri Sydväst — Huddinge, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Lorena Fernández de la Cruz, PhD — Karolinska Institutet
- Study coordinator: Sofia Asplund, MSc
- Email: sofia.asplund@ki.se
- Phone: 0046706965597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.