"Concentrated Exposure Treatment" (cET) for for Obsessive Compulsive Disorder

NCT ID: NCT02886780

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2023-06-30

Brief 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. 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Concentrated exposure treatment (cET)

Intervention Type: BEHAVIORAL

Psychological cognitive behavioral treatment

Self-help

The self-help condition (SH):

Foa, E.B. & Kozak, M.J. Mastery of obsessive-compulsive disorder: Client workbook, (Graywind Publications, New York, 1997).

Group Type: ACTIVE_COMPARATOR

Self-help

Intervention Type: BEHAVIORAL

Wait list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Concentrated exposure treatment (cET)

Psychological cognitive behavioral treatment

Intervention Type: BEHAVIORAL

Self-help

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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:

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerd Kvale, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland UH

Gunvor Launes, MD

Role: STUDY_CHAIR

Sorlandet Hospital HF

References

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.

Reference Type: DERIVED

PMID: 31803089 (View on PubMed)

Other Identifiers

2016/794 (REK vest)

Identifier Type: -

Identifier Source: org_study_id