Lifestyle program to lower heart and metabolic risk in people with obsessive-compulsive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Focused ultrasound for mood and anxiety disorders

  This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.

  Recruiting Attune Neurosciences Inc · San Francisco, California and 1 other locations · NCT07851038

• Predicting Treatment Response in Psychiatric Disorders Using Biological Markers

  This study tests whether biological markers can predict which patients with psychiatric conditions will respond to treatment.

  Recruiting Centre Hospitalier St Anne · Paris · NCT07741981

• Safety and feasibility of a next-generation dome helmet for neuromodulation in OCD

  This study tests whether a new focused ultrasound helmet can safely help people with treatment-refractory OCD see if their symptoms improve.

  Recruiting Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07704632

• Bergen Four-Day Treatment for OCD, in Finland

  This trial tests whether the Bergen Four-Day Treatment for OCD can be implemented in Finnish psychiatric care to help people with OCD see if the intensive program works in a real-world setting.

  Recruiting Tampere University Hospital · Tampere · NCT07644130

• Test different deep TMS coils and targets to treat OCD

  This study tests whether different deep TMS coils and brain targets help reduce OCD symptoms in adults with OCD, using a double-blind setup with sham and active stimulation.

  Recruiting Taipei Veterans General Hospital, Taiwan · Taipei · NCT07587112

• Role of theta brain waves in how kids control thoughts and actions

  This study tests whether theta-frequency brain activity can reveal how children with ADHD or OCD, and healthy kids, manage thinking and behavior during tasks.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07566468

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.