Obsessive-Compulsive DisorderNCT05608278
Four-day Intensive Treatment Versus Standard Cognitive Behavioral Therapy for Adults With Obsessive-compulsive Disorder
A study testing Bergen 4-Day Treatment (B4DT) and Gold standard cognitive behavioral therapy (gold standard CBT) in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The goal of this clinical trial is to compare a novel, condensed version of cognitive behavioral therapy (Bergen 4-Day Treatment, B4DT) to the gold standard psychological treatment (gold-standard CBT) for 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
- What is being tested?
- Bergen 4-Day Treatment (B4DT) and Gold standard cognitive behavioral therapy (gold standard CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSweden
- Study dates
- 17 Nov 2022to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ≥ 18 years of age.
- Primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5).
- Clinician-rated Y-BOCS score of ≥ 16
- Written informed consent.
- To be willing and able to attend treatment at any one of the two treatment clinics, regardless of the clinic where the initial assessment took place (the two clinics are located at different locations in Stockholm, about 20 Km apart).
- Be fluent in Swedish.
Who cannot join
- Other psychological treatment for OCD planned during trial period.
- Completed CBT with ERP for OCD in the last 12 months.
- Changes in psychotropic medication within the last 2 months.
- Bipolar disorder.
- Psychosis.
- Alcohol or substance dependence.
Show all 9Show fewer
- Organic brain disorder.
- Hoarding disorder or OCD with primary hoarding symptoms.
- Suicidal ideation that would warrant close monitoring.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Stockholms Läns Landsting
Stockholm
Göran Jacobsson, goran.jacobsson@sll.se
- Recruiting
Psykiatri sydväst
Stockholm
Christian Ruck, MD, PHD, +46(0)70484 33 92, Christian.ruck@ki.se
Christian Ruck, MD, PhD
About this study
Official title: Four-day Intensive Treatment Versus Standard Cognitive Behavioral Therapy for Adults With Obsessive-compulsive Disorder: a Single-blind, Randomized Controlled Non-inferiority Trial
The goal of this clinical trial is to compare a novel, condensed version of cognitive behavioral therapy (Bergen 4-Day Treatment, B4DT) to the gold standard psychological treatment (gold-standard CBT) for obsessive compulsive disorder (OCD).
The main question it aims to answer is:
- Is B4DT non-inferior to standard cognitive behavioral therapy (CBT) with regard to OCD symptoms 14 weeks after treatment start?
Adult patients with obsessive compulsive disorder will be randomly assigned to receive either gold standard CBT one to two times per week for 14 weeks, or 4 days of B4DT during one week.
Read the detailed description
Obsessive-compulsive disorder is a persistent and disabling psychiatric disorder. Individual cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is an effective treatment for OCD and is recommended as a first-line intervention. However, patients need to remain in treatment for several months and even after that, around 50% remain symptomatic despite this lengthy treatment. In response to this, a novel, condensed version of CBT, B4DT, has been developed. B4DT has shown promising results in several uncontrolled trials and one randomized controlled trial with inactive control, however it has yet to be directly compared to gold-standard individual CBT.
This single blind, randomized controlled trial with 120 patients (60 per arm) will compare B4DT to gold standard CBT. The primary outcome is the blind-rater administered Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The investigators hypothesize that B4DT will be non-inferior to gold standard CBT 14 weeks after treatment start. The non-inferiority margin is set at 4 points on the Y-BOCS.
Secondary outcomes are cost effectiveness, speed of response, response and remission rates, dropout rate, and negative effects. The investigators hypothesise that participants that receive B4DT will improve faster than patients that receive standard CTB, but for the rest of the secondary outcomes, the investigators have no directed hypotheses.
A more detailed preregistration, and all analysis scripts, are available at Open Science Framework (https://osf.io/w5bfp/).
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Bergen 4-Day Treatment (B4DT), Gold standard cognitive behavioral therapy (gold standard CBT)
- Keywords
- Cognitive Behavioral Therapy, Obsessive-Compulsive Disorder, Randomized Controlled Trial
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bergen 4-Day Treatment (B4DT)Behavioural
Novel CBT treatment
Gold standard cognitive behavioral therapy (gold standard CBT)Behavioural
Gold standard CBT treatment
| Study group | Role | What they receive |
|---|---|---|
| Bergen 4-Day Treatment (B4DT) | Experimental | Patients in this arm will receive an intensive treatment delivered mostly in group format. The group sizes will be 3-6 participants with a 1:1 patient to therapist ratio. In the week before the intensive part of the treatment, participants will have two scheduled phone/video calls with a therapist. Day 1 (half-day) of the intensive treatment includes psychoeducation and deciding on exposure tasks. Days 2 and 3 (whole days) focus on individually tailored and therapist-assisted ERP in as many most relevant settings as possible. In the evenings, patients are encouraged to continue with self-guided ERP and may receive therapist support via text messages or phone calls on demand. On day 3, patients can invite relatives to a psychoeducation session. Day 4 (half-day) of the intensive treatment focuses on treatment summary and relapse prevention, as well as planning self-guided ERP for the upcoming 3 weeks.
After 16 weeks, participants have individual follow-up sessions without ERP. Receives: Behavioral: Bergen 4-Day Treatment (B4DT) |
| Gold standard cognitive behavioral therapy (gold standard CBT) | Active comparator | Patients will receive 16 sessions of individual CBT for OCD with an emphasis on ERP, delivered over a time period of 14 weeks according to a validated protocol. Sessions will be held twice weekly at a specialist clinic during the first 2 weeks and once a week for the remaining 12 weeks. Sessions 1-2 contain psychoeducation about OCD and CBT, goal setting, and planning of ERP exercises. Sessions 3-14 include therapist-guided ERP (at the clinic, in the patients' homes or elsewhere as needed) with planned self-practice ERP between sessions. Sessions 15-16 contain a summary of the treatment and lessons learned, as well as relapse prevention and planning of continued self-practice ERP. Receives: Behavioral: Gold standard cognitive behavioral therapy (gold standard CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), clinician-administered
Clinician administered scale that measures the severity of obsessions and compulsions. Ten questions, with scores ranging from 0 to 4 (most severe), address time, interference, distress, resistance and control over obsessions and compulsions (total score range from 0 to 40).
Measured: Change from baseline to 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up
Secondary outcomes (6)
Clinical Global Impression - Severity (CGI-S)
Used to assess rates of response and remission. The Clinical Global Impression - Severity (CGI-S) and Clinical Global Impression - Improvement (CGI-I) Scales will be used to assess overall clinical severity and consequent treatment response (scores of "very much improved" (1) or "much improved" (2) will define treatment response according to previous trials in tic disorders.
Measured: 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up
Clinical Global Impression - Improvement (CGI-I)
Used to assess rates of response and remission. The Clinical Global Impression - Severity (CGI-S) and Clinical Global Impression - Improvement (CGI-I) Scales will be used to assess overall clinical severity and consequent treatment response (scores of "very much improved" (1) or "much improved" (2) will define treatment response according to previous trials in tic disorders.
Measured: 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up
Dropout rate in both arms
A dropout will be defined as a patient in the B4DT arm that participates in less than 1.5 full days at the clinic, or a patient in the gold standard CBT arm that participates in less than 8 CBT sessions.
Measured: Gold standard CBT: week 15. B4DT: week 3.
Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder. The TIC-P questionnaire measures costs in two dimensions: use of health resources and loss of productivity. Lower cost is better.
Measured: Pre-treatment, at week 15, and at the 7- and 16-month follow-ups
Negative Effects Questionnaire (NEQ)
Self-rated questionnaire on negative effects. It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances. The total score of the NEQ ranges from 0 to 80 points, a higher score reflects more negative effects.
Measured: 14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups
Assessing Quality of Life 6 Dimensions (AQoL-6D)
Used to assess cost-effectiveness. 20 questions that assess different aspects of quality of life. The AQoL provides a utility score that ranges from 1.00 (full health) to 0.00 (death-equivalent health states) to -0.04 (health states worse than death).
Measured: Change from baseline to 14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start17 Nov 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Helse-Bergen HF
- Responsible party
- Principal investigator, Christian Rück, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608278
- Sponsor's protocol ID
- OCD - B4DT vs standard CBT
- Status last verified
- Mar 2023
- First submitted
- 26 Oct 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be shared through a searchable database, Swedish national data service (SND), with restricted access. Only meta-data will be shared without restrictions. Researchers that want access to the raw data data will have to submit an additional application an ethical review board.
Publications
Ivanova E, Fondberg R, Flygare O, Sannemalm M, Asplund S, Dahlen S, Sampaio F, Andersson E, Mataix-Cols D, Ivanov VZ, Ruck C. Study protocol for a single-blind, parallel-group, randomised, controlled non-inferiority trial of 4-day intensive versus standard cognitive behavioural therapy for adults with obsessive-compulsive disorder. BMJ Open. 2023 Dec 14;13(12):e076361. doi: 10.1136/bmjopen-2023-076361.
PubMed 38101824
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-day Intensive Treatment Versus Standard Cognitive Behavioral Therapy for Adults With Obsessive-compulsive Disorder: a Single-blind, Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05608278
- Acronym / sponsor ID
- OCD - B4DT vs standard CBT
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Cognitive Behavioral Therapy, Obsessive-Compulsive Disorder, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Helse-Bergen HF
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 8 Nov 2022 (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 goal of this clinical trial is to compare a novel, condensed version of cognitive behavioral therapy (Bergen 4-Day Treatment, B4DT) to the gold standard psychological treatment (gold-standard CBT) for obsessive compulsive disorder (OCD).
The main question it aims to answer is:
- Is B4DT non-inferior to standard cognitive behavioral therapy (CBT) with regard to OCD symptoms 14 weeks after treatment start?
Adult patients with obsessive compulsive disorder will be randomly assigned to receive either gold standard CBT one to two times per week for 14 weeks, or 4 days of B4DT during one week.
Detailed description
Obsessive-compulsive disorder is a persistent and disabling psychiatric disorder. Individual cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is an effective treatment for OCD and is recommended as a first-line intervention. However, patients need to remain in treatment for several months and even after that, around 50% remain symptomatic despite this lengthy treatment. In response to this, a novel, condensed version of CBT, B4DT, has been developed. B4DT has shown promising results in several uncontrolled trials and one randomized controlled trial with inactive control, however it has yet to be directly compared to gold-standard individual CBT.
This single blind, randomized controlled trial with 120 patients (60 per arm) will compare B4DT to gold standard CBT. The primary outcome is the blind-rater administered Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The investigators hypothesize that B4DT will be non-inferior to gold standard CBT 14 weeks after treatment start. The non-inferiority margin is set at 4 points on the Y-BOCS.
Secondary outcomes are cost effectiveness, speed of response, response and remission rates, dropout rate, and negative effects. The investigators hypothesise that participants that receive B4DT will improve faster than patients that receive standard CTB, but for the rest of the secondary outcomes, the investigators have no directed hypotheses.
A more detailed preregistration, and all analysis scripts, are available at Open Science Framework (https://osf.io/w5bfp/).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bergen 4-Day Treatment (B4DT) | Experimental | Behavioral: Bergen 4-Day Treatment (B4DT)Patients in this arm will receive an intensive treatment delivered mostly in group format. The group sizes will be 3-6 participants with a 1:1 patient to therapist ratio. In the week before the intensive part of the treatment, participants will have two scheduled phone/video calls with a therapist. Day 1 (half-day) of the intensive treatment includes psychoeducation and deciding on exposure tasks. Days 2 and 3 (whole days) focus on individually tailored and therapist-assisted ERP in as many most relevant settings as possible. In the evenings, patients are encouraged to continue with self-guided ERP and may receive therapist support via text messages or phone calls on demand. On day 3, patients can invite relatives to a psychoeducation session. Day 4 (half-day) of the intensive treatment focuses on treatment summary and relapse prevention, as well as planning self-guided ERP for the upcoming 3 weeks. After 16 weeks, participants have individual follow-up sessions without ERP. |
| Gold standard cognitive behavioral therapy (gold standard CBT) | Active comparator | Behavioral: Gold standard cognitive behavioral therapy (gold standard CBT)Patients will receive 16 sessions of individual CBT for OCD with an emphasis on ERP, delivered over a time period of 14 weeks according to a validated protocol. Sessions will be held twice weekly at a specialist clinic during the first 2 weeks and once a week for the remaining 12 weeks. Sessions 1-2 contain psychoeducation about OCD and CBT, goal setting, and planning of ERP exercises. Sessions 3-14 include therapist-guided ERP (at the clinic, in the patients' homes or elsewhere as needed) with planned self-practice ERP between sessions. Sessions 15-16 contain a summary of the treatment and lessons learned, as well as relapse prevention and planning of continued self-practice ERP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age.
- Primary diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5).
- Clinician-rated Y-BOCS score of ≥ 16
- Written informed consent.
- To be willing and able to attend treatment at any one of the two treatment clinics, regardless of the clinic where the initial assessment took place (the two clinics are located at different locations in Stockholm, about 20 Km apart).
Key exclusion criteria (9 listed)
- Other psychological treatment for OCD planned during trial period.
- Completed CBT with ERP for OCD in the last 12 months.
- Changes in psychotropic medication within the last 2 months.
- Bipolar disorder.
- Psychosis.
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 |
|---|---|---|
| Bergen 4-Day Treatment (B4DT)Novel CBT treatment | Behavioural | Bergen 4-Day Treatment (B4DT) |
| Gold standard cognitive behavioral therapy (gold standard CBT)Gold standard CBT treatment | Behavioural | Gold standard cognitive behavioral therapy (gold standard CBT) |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), clinician-administered
Time frame: Change from baseline to 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up
Clinician administered scale that measures the severity of obsessions and compulsions. Ten questions, with scores ranging from 0 to 4 (most severe), address time, interference, distress, resistance and control over obsessions and compulsions (total score range from 0 to 40).
6 secondary outcomes
Clinical Global Impression - Severity (CGI-S)
Time frame: 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up
Clinical Global Impression - Improvement (CGI-I)
Time frame: 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up
Dropout rate in both arms
Time frame: Gold standard CBT: week 15. B4DT: week 3.
Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Time frame: Pre-treatment, at week 15, and at the 7- and 16-month follow-ups
Negative Effects Questionnaire (NEQ)
Time frame: 14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups
Assessing Quality of Life 6 Dimensions (AQoL-6D)
Time frame: Change from baseline to 14 weeks after treatment start. Additional measures at the 7- and 16-month follow-ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 38101824Ivanova E, Fondberg R, Flygare O, Sannemalm M, Asplund S, Dahlen S, Sampaio F, Andersson E, Mataix-Cols D, Ivanov VZ, Ruck C. Study protocol for a single-blind, parallel-group, randomised, controlled non-inferiority trial of 4-day intensive versus standard cognitive behavioural therapy for adults with obsessive-compulsive disorder. BMJ Open. 2023 Dec 14;13(12):e076361. doi: 10.1136/bmjopen-2023-076361.
- Individual participant dataSharing planned: Yes. Raw data will be shared through a searchable database, Swedish national data service (SND), with restricted access. Only meta-data will be shared without restrictions. Researchers that want access to the raw data data will have to submit an additional application an ethical review board.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bergen 4-Day Treatment (B4DT) and Gold standard cognitive behavioral therapy (gold standard CBT) in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Rück, PhD (+46704843392, christian.ruck@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), clinician-administered (time frame: Change from baseline to 14 weeks after treatment start. Additional measures at week 4 and 7, and at the 7- and 16-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05608278, which also lists 1 linked publication.
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 7 Mar 2023.