A Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder

Official title

Efficacy and Cost-effectiveness of a Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder: A Randomized Controlled Trial

Overview

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).

Detailed description

Obsessive-compulsive disorder (OCD) is a prevalent and impairing disorder with an increased risk of morbidity and mortality due to cardiometabolic diseases. These risks remain significant over and above psychiatric comorbidities and shared familial factors, indicating that at least part of this risk could be a consequence of pernicious lifestyle habits (e.g., physical inactivity, unhealthy diet). A lifestyle intervention targeting cardiometabolic risk factors in people with OCD has previously been deemed feasible, acceptable, and safe. However, the efficacy and cost-effectiveness of the intervention need to be investigated. This will be the first RCT to examine the effects of a lifestyle intervention on the health and well-being of people with OCD.

The specific aims are:

1. to investigate whether the intervention, compared to medical and lifestyle advice (control), is effective in increasing physical activity (objectively measured with an accelerometer); 2. to investigate the efficacy of the intervention, vs. the control, in changing cardiometabolic risk factors (lifestyle habits, cardiometabolic physiological, and laboratory measurements), mental health measures, functional impairment, and quality of life; and 3. to evaluate whether the lifestyle intervention, vs. the control, is cost-effective from a healthcare provider perspective.

Interventions

• Behavioral A group-based lifestyle intervention for individuals with OCD
  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 app
• Behavioral Medical and lifestyle advice
  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,

Primary outcome measures

• Physical activity: Steps per day [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.]

Secondary outcome measures (12)

• Physical activity: Moderate to vigorous physical activity (MVPA) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.]
• International Physical Activity Questionnaire, short form (IPAQ-SF) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• 15-item Food Frequency Questionnaire (FFQ) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• Alcohol Use Disorder Identification Test for Consumption (AUDIT-C) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• Tobacco use [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• Perceived Stress Scale (PSS) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• Insomnia Severity Scale (ISI) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• Obsessive-Compulsive Inventory - 12 (OCI-12) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• EuroQol five dimensional five level questionnaire (EQ-5D-5L) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]
• Work and Social Adjustment Scale (WSAS) [Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 3 months after the primary endpoint, 6 months after the primary endpoint, 12 months after the primary endpoint.]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Sweden · 1 center

• OCD-Programmet, Psykiatri Sydväst — Huddinge

Identifiers

NCT: NCT07206212 · 2025-04734-01 · 20210493, 20220899 · 2022-005109, 2025-02741 · 2019-00438 · 20200139 · 2020-01361, 2022-01675

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗