A Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
A group-based lifestyle intervention for individuals with OCD
BehavioralParticipants 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.
Medical and lifestyle advice
BehavioralOne 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.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Active interventionExperimental treatment 1 intervention
Group B: Medical and lifestyle adviceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Physical activity: Steps per day
Measured as change in steps/day with an accelerometer. Participants will be asked to wear an accelerometer (activPAL™) 24 hours/day for seven consecutive days at each assessment point. The device is placed on the thigh. Data will be considered valid if wear time is ≥10 hours/day for at least 4 days, including at least one weekend day.
Time frame
Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.Secondary outcomes
1
Physical activity: Moderate to vigorous physical activity (MVPA)
MVPA per day operationalised as a walking cadence of \>100 steps/minute.
Time frame
Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.2
International Physical Activity Questionnaire, short form (IPAQ-SF)
Self-reported assessment of physical activity (moderately intense activities, vigorously intense activities, walking) and sedentary time during the last 7 days. Responses on each physical activity intensity question will be converted to metabolic equivalent of task (MET) minutes, using the formula from the IPAQ scoring protocol. Both the continuous and categorical scores (high, moderate, and low) will be calculated according to the scoring guidelines. A higher MET score corresponds to higher levels of physical activity.
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.3
15-item Food Frequency Questionnaire (FFQ)
Self-reported assessment of dietary patterns. It consists of 15 items concerning dietary choices, where each item is evaluated as either meeting or not meeting the guidelines set in the Nordic Nutrition Recommendations (NNR). Each met recommendation receives 1 point, resulting in a healthy eating index ranging from 0 to 15 points. Based on this index, dietary patterns are classified as good (9 or more points), average (6-8 points) or poor (5 or fewer points).
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.4
Alcohol Use Disorder Identification Test for Consumption (AUDIT-C)
Self-reported assessment of alcohol consumption. Scores in the AUDIT-C range from 0 to 12 points, where 0 points indicate no alcohol use. Cut-off scores for risk consumption vary across settings and population, but a score ≥4 points has been suggested as a cut-off for detecting risk consumption of alcohol when validated in the general population.
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.Other outcomes
1
Adverse events
Measured with a short questionnaire created by the research team regarding potential adverse events (e.g., increased anxiety, headaches, increased tiredness, musculoskeletal pain). They will also be able to write own examples on negative experiences connected to participation in the intervention.
Time frame
Week 7 after the start of the intervention, week 14 after the start of the intervention (primary endpoint).2
Concurrent interventions
At each measurement point, information will be collected on any treatment changes (e.g., changes in medication, initiation of psychological treatment) and/or initiation of concurrent interventions to improve lifestyle habits (including e.g., vitamin supplements) or cardiometabolic risk factors.
Time frame
Baseline, week 7 after the start of the intervention, 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.Sponsors and contacts
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Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Source ClinicalTrials.gov