Obsessive Compulsive Disorder (OCD)LIFTNCT07206212
A Lifestyle Intervention to Reduce Cardiometabolic Risk Factors in Individuals With Obsessive-compulsive Disorder
A study testing A group-based lifestyle intervention for individuals with OCD and Medical and lifestyle advice in people with Obsessive Compulsive Disorder (OCD) and Lifestyle (Sedentary Behavior and Physical Activity), run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD), Lifestyle (Sedentary Behavior and Physical Activity)
- What is being tested?
- A group-based lifestyle intervention for individuals with OCD and Medical and lifestyle advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jan 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
OCD-Programmet, Psykiatri Sydväst
Huddinge, Stockholm County, 141 57
Lina Martinsson, PhD, 00468-123 800 00, lina.martinsson@sll.se
About this study
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
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).
Read the 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:
- to investigate whether the intervention, compared to medical and lifestyle advice (control), is effective in increasing physical activity (objectively measured with an accelerometer);
- 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
- to evaluate whether the lifestyle intervention, vs. the control, is cost-effective from a healthcare provider perspective.
- Being tested
- A group-based lifestyle intervention for individuals with OCD, Medical and lifestyle advice
- Keywords
- OCD, Obsessive-compulsive disorder, Cardiovascular disease, Metabolic syndrome, Prevention, Lifestyle habits, Physical activity
- Medical subject headings
- Obsessive-Compulsive Disorder, Sedentary Behavior, Motor Activity, Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A group-based lifestyle intervention for individuals with OCDBehavioural
Also called LIFT
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.
Medical and lifestyle adviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | The lifestyle intervention (LIFT) consists of one initial individual session to create a personal plan and set up goals for a change of lifestyle habits (week 1) and 12 weekly group sessions (weeks 2 to 13) including both education on lifestyle habits and physical exercise. After week 13, participants get access to a booster module in a digital platform to help them maintain their behavioral changes. Receives: Behavioral: A group-based lifestyle intervention for individuals with OCD |
| Medical and lifestyle advice | Active comparator | Participants in this arm will receive one individual session where participants will receive feedback based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk (week 1). Additionally, participants will receive written educational information on healthy lifestyle habits. Receives: Behavioral: Medical and lifestyle advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Secondary outcomes (37)
Physical activity: Moderate to vigorous physical activity (MVPA)
MVPA per day operationalised as a walking cadence of >100 steps/minute.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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
Evaluated by asking self-reported questions about current or previous use of cigarettes, snus or other tobacco or nicotine products. If current use, or if they quit during the last 6 months, participants are asked to specify frequency (daily, sometimes) and amount used.
Measured: 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)
Self-reported assessment of perceived stress. The total score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.
Measured: 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)
Self-reported assessment of sleep problems and severity of symptoms. Consists of 7 items that are rated on a 5-point Likert scale to evaluate sleep problems and severity of symptoms. The total score ranges from 0 to 28 points, with a higher score indicating more severe sleep problems.
Measured: 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)
Clinician-rated semi-structured interview to assess OCD symptom severity. The Y-BOCS consists of 10 items rated from 0 to 4, with a total score from 0 to 40, where a higher score corresponds to more severe OCD.
Measured: 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)
Self-reported assessment of OCD symptoms. Consists of 12 items rated on a 5-point Likert scale, with total scores ranging from 0-48. Scores between 0 and 12 indicate mild, between 13 and 21 indicate moderate, and between 22 and 48 indicate severe OCD symptoms.
Measured: 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)
Self-reported assessment of symptoms of depression. In this 9-item scale the total score ranges from 0 to 27 points, with a higher score corresponding to more severe symptoms of depression.
Measured: 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)
Self-rated assessment of own health status in five dimensions (mobility; self-care; usual activities; pain/discomfort; and anxiety/depression), within five levels of severity (no problems; slight problems; moderate problems; severe problems; or extreme problems). The scale also comprises a rating of their overall health status on a scale from 0-100 (0 = worst imaginable health; 100 = best imaginable health), the EQ-VAS scale. The scores are combined to calculate a health utility number, with the health utilities ranging from -0.31 for the worst to 1 for the best EQ-5D-5L states in Sweden.
Measured: 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)
Self-reported assessment of impairment in functioning, in terms of work, home management, social leisure activities, private leisure activities, and relationships. Each item is rated on a scale from 0 to 8, with the total score ranging from 0 to 40. A higher score corresponds to more impairment in functioning.
Measured: 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.
Waist circumference
Measured in a standing position, midway between the lower rib margin and the iliac crest, in centimeters (cm) at the nearest 0.5 cm.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Sagittal abdominal diameter
Measured in a supine position at the nearest 0.1 centimeter with a ruler and a water lever or a caliper, at the level of the umbilical.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Weight
Measured in kilograms, to the nearest 0.1 kg.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Body Mass Index (BMI)
Derived by dividing weight (in kilograms measured to the nearest 0.1 kg) by height (in meters measured to the nearest 0.1 cm) squared.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Systolic and diastolic blood pressure
Measured in a seated position after ten minutes of rest, with a standard sphygmomanometer. The measurement will be taken twice with 1 minute between measures, according to the gold standard for measuring blood pressure.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Resting heart rate
Measured in a seated position following a 5 minute rest.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Total cholesterol
Blood will be drawn following an overnight fast (minimum 8 hours, or else rescheduled). Measured as mmol/l.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
S-low density lipoprotein cholesterol
Blood will be drawn following an overnight fast (minimum 8 hours, or else rescheduled). Measured as mmol/l.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
S-high density lipoprotein cholesterol
Blood will be drawn following an overnight fast (minimum 8 hours, or else rescheduled). Measured as mmol/l.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Lipoprotein (a)
Blood will be drawn following an overnight fast (minimum 8 hours, or else rescheduled). Measured as nmol/l.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Fasting triglycerides
Blood will be drawn following an overnight fast (minimum 8 hours). Measured as mmol/l.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Fasting plasma glucose
Blood will be drawn following an overnight fast (minimum 8 hours). Measured as mmol/l.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Glycated hemoglobin
Blood will be drawn following an overnight fast (minimum 8 hours) (HbA1c, mmol/l). It reflects average plasma glucose over the previous 8-12 weeks.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Thyroid stimulating hormone (TSH)
Blood will be drawn following an overnight fast (minimum 8 hours). Measured as mE/L.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Cobalamin
Blood will be drawn following an overnight fast (minimum 8 hours). Reflects vitamin B12 status. Measured in pmol/L.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Homocysteine
Blood will be drawn following an overnight fast (minimum 8 hours). Measured in µmol/L.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
25-OHD-vitamin
Blood will be drawn following an overnight fast (minimum 8 hours). Main marker of vitamin D status in the body, reported in nmol/L.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Folate
Blood will be drawn following an overnight fast (minimum 8 hours). Reported in nmol/L.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Iron deposits: Iron
Blood will be drawn following an overnight fast (minimum 8 hours). Iron [Fe], reported in µmol/L.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Iron deposits: Transferrin
Blood will be drawn following an overnight fast (minimum 8 hours). Reported in µg/L.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
High-sensitive C-reactive protein (CRP)
Blood will be drawn following an overnight fast (minimum 8 hours). Reported in mg/L.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
White blood cell telomere length
Blood will be drawn following an overnight fast (minimum 8 hours). Telomere length in leukocytes will be measured, reported as relative telomere length (T/S ratio).
Measured: Baseline, week 14 after the start of the intervention (primary endpoint).
Inflammation panel
Blood will be drawn following an overnight fast (minimum 8 hours). Immune activity plasma proteins (n=92) will be analysed using the Olink Target 96 Inflammation panel.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint).
Extracellular vesicles (EVs)
Blood will be drawn following an overnight fast (minimum 8 hours). EVs will be isolated from plasma using differential ultracentrifugation. Quantification and separation of EVs will be performed using flow cytometry using antibodies specifically marking EVs with regards to being a microparticle and their tissue of origin. We will investigate the amount and origin of EVs from the vascular endothelium, leukocytes, platelets, and the skeletal muscle. To assess the cargo of particularly interesting EVs, RNA will be isolated and miRNA profiled using the robust and high-throughput nCounter (Nanostring).
Measured: Baseline, week 14 after the start of the intervention (primary endpoint).
Biological age
Blood will be drawn following an overnight fast (minimum 8 hours). DNA will be extracted using the Chemagen kits on the Hamilton ChemagicSTAR® platform. Bisulfite conversion will be conducted using the EZ-96 DNA Methylation-Lightning Kit (D5033). The Illumina Infinium MethylationEPIC v.2 array will be used to quantify DNAm at ~930,000 sites. Raw methylation data will be pre-processed using standard quality control steps, including removal of low-quality probes (e.g., detection p-value >0.01), background correction, and normalization. Biological aging patterns will be assessed through epigenetic age calculations using state-of-the-art algorithms (e.g., GrimAge). Accelerated biological age will be calculated as the residual from regressing epigenetic age on chronological age.
Measured: Baseline, week 14 after the start of the intervention (primary endpoint).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start30 Jan 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Lorena Fernández de la Cruz, PhD, Karolinska Institutet
- Investigators
- Lorena Fernández de la Cruz, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206212
- Sponsor's protocol ID
- 2025-04734-01
- Other IDs
- 20210493, 20220899, 2022-005109, 2025-02741, 2019-00438, 20200139, 2020-01361, 2022-01675, 2019, 2025
- Acronym
- LIFT
- Status last verified
- May 2026
- First submitted
- 11 Sep 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators may potentially share trial data from the study with other researchers around the world. The use would primarily be to combine outcome data for potential meta-analyses in this research field. Shared data will be pseudonymised. The possibility of future data sharing is mentioned in the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07206212
- Acronym / sponsor ID
- LIFT / 2025-04734-01
- Keywords
- OCD, Obsessive-compulsive disorder, Cardiovascular disease, Metabolic syndrome, Prevention, Lifestyle habits, Physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to investigate whether the intervention, compared to medical and lifestyle advice (control), is effective in increasing physical activity (objectively measured with an accelerometer);
- 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
- to evaluate whether the lifestyle intervention, vs. the control, is cost-effective from a healthcare provider perspective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Behavioral: A group-based lifestyle intervention for individuals with OCDThe lifestyle intervention (LIFT) consists of one initial individual session to create a personal plan and set up goals for a change of lifestyle habits (week 1) and 12 weekly group sessions (weeks 2 to 13) including both education on lifestyle habits and physical exercise. After week 13, participants get access to a booster module in a digital platform to help them maintain their behavioral changes. |
| Medical and lifestyle advice | Active comparator | Behavioral: Medical and lifestyle adviceParticipants in this arm will receive one individual session where participants will receive feedback based on the baseline evaluation of their clinical characteristics, lifestyle habits, and cardiometabolic risk (week 1). Additionally, participants will receive written educational information on healthy lifestyle habits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A group-based lifestyle intervention for individuals with OCDAlso: LIFTParticipants 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. | Behavioural | Active intervention |
| Medical and lifestyle adviceOne 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. | Behavioural | Medical and lifestyle advice |
Primary outcome
Physical activity: Steps per day
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
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.
37 secondary outcomes
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.
Waist circumference
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Sagittal abdominal diameter
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Weight
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Body Mass Index (BMI)
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Systolic and diastolic blood pressure
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Resting heart rate
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Total cholesterol
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
S-low density lipoprotein cholesterol
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
S-high density lipoprotein cholesterol
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Lipoprotein (a)
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Fasting triglycerides
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Fasting plasma glucose
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Glycated hemoglobin
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Thyroid stimulating hormone (TSH)
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Cobalamin
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Homocysteine
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
25-OHD-vitamin
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Folate
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Iron deposits: Iron
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
Iron deposits: Transferrin
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
High-sensitive C-reactive protein (CRP)
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.
White blood cell telomere length
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint).
Inflammation panel
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint).
Extracellular vesicles (EVs)
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint).
Biological age
Time frame: Baseline, week 14 after the start of the intervention (primary endpoint).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No. The investigators may potentially share trial data from the study with other researchers around the world. The use would primarily be to combine outcome data for potential meta-analyses in this research field. Shared data will be pseudonymised. The possibility of future data sharing is mentioned in the informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorena Fernández de la Cruz, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A group-based lifestyle intervention for individuals with OCD and Medical and lifestyle advice in people with Obsessive Compulsive Disorder (OCD) and Lifestyle (Sedentary Behavior and Physical Activity), run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Asplund, MSc (0046706965597 ext. 0046706965597, sofia.asplund@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity: Steps per day (time frame: Baseline, week 14 after the start of the intervention (primary endpoint), 12 months after the primary endpoint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.