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

NCT02886780 | Unknown

• 1 other identifier: 2016/794 (REK vest)
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up

Secondary Outcomes (6)

• Well-being

  Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up

• Work and social adjustment

  Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up

• Generalized anxiety

  Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up

• Depression

  Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up

• Insomnia

  Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow up

Study Arms (3)

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)

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).

Behavioral: Self-help

Wait list

NO INTERVENTION

Interventions

Concentrated exposure treatment (cET) BEHAVIORAL

Psychological cognitive behavioral treatment

Concentrated Exposure Treatment (cET)

Self-help BEHAVIORAL

Self-help

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Sorlandet Hospital HF: collaborator

Related Publications (1)

• 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.

  PMID: 31803089 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Gerd Kvale, PhD

  Haukeland UH

  PRINCIPAL INVESTIGATOR

• Gunvor Launes, MD

  Sorlandet Hospital HF

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 1, 2016
• Study Start: September 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2023
• Last Updated: February 11, 2021

Record last verified: 2020-02