A Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals 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
Karolinska Institutet
108 participants
Jan 30, 2026
INTERVENTIONAL
Conditions
Summary
The overall aim of this study is to evaluate the efficacy and cost-effectiveness of a lifestyle intervention to improve lifestyle habits and reduce cardiometabolic risk factors in individuals with obsessive-compulsive disorder (OCD).
Eligibility
Inclusion Criteria3
- 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.
- 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).
- 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 Criteria9
- 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.
- 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.
- Being pregnant or \<1 year postpartum. Screened at the initial phone call and confirmed by the assessor at the inclusion assessment (psychiatric interview).
- 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).
- 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.
- 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).
- Inability to understand and communicate in Swedish. Confirmed by the assessor at the initial phone call.
- 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).
- 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).
Interventions
Participants will take part in 13 week program, with one individual session to set up goals for a change of lifestyle habits, based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk, and 12 group sessions, consisting of both education on lifestyle habits and physical exercise. Each educational session will focus on a specific topic/lifestyle habit, alternating more informative sessions with sessions discussing how the information can be applied, taking into account specific hinders due to Obsessive-Compulsive Disorder. Between-sessions homework will include, for example, daily registration of physical activity and implementing changes in the lifestyle habits discussed during each session. All homework assignments will be registered in a digital platform. After the 13 weeks of lifestyle intervention, participants will get access to a booster module in the digital platform to help them maintain their behavioral changes.
One individual session with a clinical psychologist on week 1 of about 1 hour of duration. During this session, participants will receive feedback based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk. Participants also receive written educational information on healthy lifestyle habits based on national Swedish guidelines issued by the National Board of Health and Welfare. The recommendations include engaging in regular physical activity, dietary guidelines based on Nordic Nutrition Recommendations, and advice to reduce alcohol consumption and quit tobacco use.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07206212