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Concentrated Exposure Treatment (cET) for for Obsessive Compulsive Disorder

Concentrated Exposure Treatment (cET) for Obsessive Compulsive Disorder (OCD). A Randomized Controlled Trial (RCT)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02886780
Enrollment
48
Registered
2016-09-01
Start date
2016-09-30
Completion date
2023-06-30
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder (OCD)

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.

Interventions

BEHAVIORALConcentrated exposure treatment (cET)

Psychological cognitive behavioral treatment

BEHAVIORALSelf-help

Sponsors

Sorlandet Hospital HF
CollaboratorOTHER_GOV
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-helpPre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow upY-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 SCIDPre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up

Secondary

MeasureTime frameDescription
Generalized anxietyPre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow upGeneralized 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
DepressionPre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow upPatient 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).
Well-beingPre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow upThe 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.
Client satisfaction1 week post Concentrated Exposure TreatmentClient Satisfaction Questionnaire (CSQ-8) is an eight-item self-report form where patients report their level of satisfaction with the treatment they have undergone.
InsomniaPre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow upThe 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
Work and social adjustmentPre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow upThe Work and Social Adjustment Scale (W & SAS) is a short questionnaire measuring work and social adjustment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026