Obsessive Compulsive Disorder (OCD)NCT02886780
"Concentrated Exposure Treatment" (cET) for for Obsessive Compulsive Disorder
A study testing Concentrated exposure treatment (cET) and Self-help in people with Obsessive Compulsive Disorder (OCD), run by Haukeland University Hospital.
Trial summary
Obsessive Compulsive Disorder (OCD) often becomes chronic if not treated. Exposure and response prevention (ERP) is recommended psychological treatment. The OCD-team at Haukeland University hospital has developed a concentrated 4-day treatment format which has been evaluated as part of standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Concentrated exposure treatment (cET) and Self-help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jun 2023
- 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
- OCD-patients referred to the OCD-team at Sørlandet Sykehus, Solvang DPS will be included.
- Outpatients
- ≥ 18 years of age
- Fulfilling diagnostic criteria of OCD according to the DSM-5
- Y-BOCS ≥ 16
- Fluent in Norwegian
- Signed informed consent
Who cannot join
- OCD symptoms primarily associated with hoarding
- Ongoing substance abuse/dependence
- Bipolar disorder or psychosis
- Ongoing suicidal ideation
- Mental Retardation, based on previous medical history
- If using antidepressants:
Show all 12Show fewer
- Not on stable dosage 4 weeks before the intervention
- Unwilling to remain on stable dosage during the four intervention days
- Unwilling to refrain from anxiety reducing substances, such as anxiolytics (e.g. benzodiazepines) and alcohol during the two days of exposure.
- Patients living > 1.5 hour drive by car/ train from the treatment location.
- Patients with a BMI-index considered too low for participation in psychological treatment
- Patients with a full course of prior CBT for OCD.
About this study
Official title: Concentrated Exposure Treatment (cET) for Obsessive Compulsive Disorder (OCD). A Randomized Controlled Trial (RCT)
Obsessive Compulsive Disorder (OCD) often becomes chronic if not treated. Exposure and response prevention (ERP) is recommended psychological treatment. The OCD-team at Haukeland University hospital has developed a concentrated 4-day treatment format which has been evaluated as part of standard care. Next step in the methodological development is to conduct a randomized controlled trial where the 4-day format is compared to self-help and waiting list. The study will be conducted at Solvang DPS, Sørlandet Hospital. Participants (16 in each group) are ordinary patients (>18 yrs) entitled to care in the specialist health care.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Concentrated exposure treatment (cET), Self-help
- 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.
Concentrated exposure treatment (cET)Behavioural
Psychological cognitive behavioral treatment
Self-helpBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Concentrated Exposure Treatment (cET) | Experimental | Please refer to:Havnen, A., Hansen, B., Öst, L.-G. \& Kvale, G. Concentrated ERP delivered in a group setting: An effectiveness study. Journal of Obsessive Compulsive and Related Disorders 3, 319-324 (2014) Receives: Behavioral: Concentrated exposure treatment (cET) |
| Self-help | Active comparator | The self-help condition (SH):
Foa, E.B. \& Kozak, M.J. Mastery of obsessive-compulsive disorder: Client workbook, (Graywind Publications, New York, 1997). Receives: Behavioral: Self-help |
| Wait list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-help
Y-BOCS changes will for all conditions be calculated by two approaches which will be compared.
Measured: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Changes i OCD diagnostic status (DSM-5) as measured by SCID
Measured: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Secondary outcomes (6)
Well-being
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) will be administered to assess mental well-being. This scale has 14 items covering different aspects of mental health related to mental well-being.
Measured: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Work and social adjustment
The Work and Social Adjustment Scale (W \& SAS) is a short questionnaire measuring work and social adjustment.
Measured: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Generalized anxiety
Generalized Anxiety Disorder Assessment 7 (GAD-7) is a brief 7-item self-report measure for generalized anxiety symptoms. Although developed for measuring severity of generalized anxiety disorder, the GAD-7 measures severity of general anxiety symptoms common to several anxiety disorders
Measured: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Depression
Patient Health Questionnaire, (PHQ-9) is a 9-item self-report questionnaire measuring level of depressive symptoms. Items are scored on a scale from 0 (not at all) to 3 (nearly every day).
Measured: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Insomnia
The Bergen Insomnia Scale (BIS) will be used to screen for sleep disturbances. The scale has six items covering different aspects of sleep disturbances the past 4 weeks
Measured: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow up
Client satisfaction
Client Satisfaction Questionnaire (CSQ-8) is an eight-item self-report form where patients report their level of satisfaction with the treatment they have undergone.
Measured: 1 week post Concentrated Exposure Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018
- Study completionJun 2023 (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 Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Responsible party
- Sponsor
- Investigators
- Gerd Kvale, PhD, Principal investigator, Haukeland UHGunvor Launes, MD, Study chair, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886780
- Sponsor's protocol ID
- 2016/794 (REK vest)
- Status last verified
- Feb 2020
- First submitted
- 29 Aug 2016
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Launes G, Hagen K, Sunde T, Ost LG, Klovning I, Laukvik IL, Himle JA, Solem S, Hystad SW, Hansen B, Kvale G. A Randomized Controlled Trial of Concentrated ERP, Self-Help and Waiting List for Obsessive- Compulsive Disorder: The Bergen 4-Day Treatment. Front Psychol. 2019 Nov 15;10:2500. doi: 10.3389/fpsyg.2019.02500. eCollection 2019.
PubMed 31803089
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrated Exposure Treatment (cET) for Obsessive Compulsive Disorder (OCD). A Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT02886780
- Acronym / sponsor ID
- 2016/794 (REK vest)
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- 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.
Obsessive Compulsive Disorder (OCD) often becomes chronic if not treated. Exposure and response prevention (ERP) is recommended psychological treatment. The OCD-team at Haukeland University hospital has developed a concentrated 4-day treatment format which has been evaluated as part of standard care. Next step in the methodological development is to conduct a randomized controlled trial where the 4-day format is compared to self-help and waiting list. The study will be conducted at Solvang DPS, Sørlandet Hospital. Participants (16 in each group) are ordinary patients (>18 yrs) entitled to care in the specialist health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concentrated Exposure Treatment (cET) | Experimental | Behavioral: Concentrated exposure treatment (cET)Please refer to:Havnen, A., Hansen, B., Öst, L.-G. \& Kvale, G. Concentrated ERP delivered in a group setting: An effectiveness study. Journal of Obsessive Compulsive and Related Disorders 3, 319-324 (2014) |
| Self-help | Active comparator | Behavioral: Self-helpThe self-help condition (SH): Foa, E.B. \& Kozak, M.J. Mastery of obsessive-compulsive disorder: Client workbook, (Graywind Publications, New York, 1997). |
| Wait list | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- OCD-patients referred to the OCD-team at Sørlandet Sykehus, Solvang DPS will be included.
- Outpatients
- ≥ 18 years of age
- Fulfilling diagnostic criteria of OCD according to the DSM-5
- Y-BOCS ≥ 16
Key exclusion criteria (12 listed)
- OCD symptoms primarily associated with hoarding
- Ongoing substance abuse/dependence
- Bipolar disorder or psychosis
- Ongoing suicidal ideation
- Mental Retardation, based on previous medical history
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 |
|---|---|---|
| Concentrated exposure treatment (cET)Psychological cognitive behavioral treatment | Behavioural | Concentrated Exposure Treatment (cET) |
| Self-help | Behavioural | Self-help |
Primary outcome
Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-help
Time frame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Y-BOCS changes will for all conditions be calculated by two approaches which will be compared.
Changes i OCD diagnostic status (DSM-5) as measured by SCID
Time frame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
6 secondary outcomes
Well-being
Time frame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Work and social adjustment
Time frame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Generalized anxiety
Time frame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Depression
Time frame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Insomnia
Time frame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow up
Client satisfaction
Time frame: 1 week post Concentrated Exposure Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 31803089Launes G, Hagen K, Sunde T, Ost LG, Klovning I, Laukvik IL, Himle JA, Solem S, Hystad SW, Hansen B, Kvale G. A Randomized Controlled Trial of Concentrated ERP, Self-Help and Waiting List for Obsessive- Compulsive Disorder: The Bergen 4-Day Treatment. Front Psychol. 2019 Nov 15;10:2500. doi: 10.3389/fpsyg.2019.02500. eCollection 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Obsessive Compulsive Disorder (OCD)
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder: A Randomized Controlled Trial
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
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.
Gerd Kvale, PhD principal investigator
Haukeland UH
Gunvor Launes, MD study chair
Sorlandet Hospital HF
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated exposure treatment (cET) and Self-help in people with Obsessive Compulsive Disorder (OCD), run by Haukeland University Hospital.
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 7 inclusion and 12 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-help (time frame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up). The study lists 2 primary outcomes in all. 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 NCT02886780, 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 11 Feb 2021.