Clinical trial NCT02886780: "Concentrated Exposure Treatment" (cET) for for Obsessive Compulsive Disorder
Official title: Concentrated Exposure Treatment (cET) for Obsessive Compulsive Disorder (OCD). A Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive Compulsive Disorder (OCD)
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Sorlandet Hospital HF
First posted: 2016-09-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

OCD-patients referred to the OCD-team at Sørlandet Sykehus, Solvang DPS will be included.

Inclusion criteria

* 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.

Primary outcomes:
measure: Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-help
timeFrame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
measure: Changes i OCD diagnostic status (DSM-5) as measured by SCID
timeFrame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
Secondary outcomes:
measure: Well-being
timeFrame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
measure: Work and social adjustment
timeFrame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
measure: Generalized anxiety
timeFrame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
measure: Depression
timeFrame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
measure: Insomnia
timeFrame: Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow up
measure: Client satisfaction
timeFrame: 1 week post Concentrated Exposure Treatment
Other outcomes:
Locations:
Study officials:
affiliation: Haukeland UH
name: Gerd Kvale, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sorlandet Hospital HF
name: Gunvor Launes, MD
role: STUDY_CHAIR
References:
citation: 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.