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

Primary Purpose

Obsessive Compulsive Disorder (OCD)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Concentrated exposure treatment (cET)
Self-help
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder (OCD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Concentrated Exposure Treatment (cET)

    Self-help

    Wait list

    Arm Description

    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)

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

    Outcomes

    Primary Outcome Measures

    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.
    Changes i OCD diagnostic status (DSM-5) as measured by SCID

    Secondary Outcome Measures

    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.
    Work and social adjustment
    The Work and Social Adjustment Scale (W & SAS) is a short questionnaire measuring work and social adjustment.
    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
    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).
    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
    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.

    Full Information

    First Posted
    August 29, 2016
    Last Updated
    February 10, 2021
    Sponsor
    Haukeland University Hospital
    Collaborators
    Sorlandet Hospital HF
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02886780
    Brief Title
    "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

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Haukeland University Hospital
    Collaborators
    Sorlandet Hospital HF

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive Compulsive Disorder (OCD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Concentrated Exposure Treatment (cET)
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Self-help
    Arm Type
    Active Comparator
    Arm Description
    The self-help condition (SH): Foa, E.B. & Kozak, M.J. Mastery of obsessive-compulsive disorder: Client workbook, (Graywind Publications, New York, 1997).
    Arm Title
    Wait list
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Concentrated exposure treatment (cET)
    Intervention Description
    Psychological cognitive behavioral treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-help
    Primary Outcome Measure Information:
    Title
    Changes in Y-BOCS from pre cET-treatment to post treatment/ waiting list/ self-help
    Description
    Y-BOCS changes will for all conditions be calculated by two approaches which will be compared.
    Time Frame
    Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Well-being
    Description
    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.
    Time Frame
    Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
    Title
    Work and social adjustment
    Description
    The Work and Social Adjustment Scale (W & SAS) is a short questionnaire measuring work and social adjustment.
    Time Frame
    Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
    Title
    Generalized anxiety
    Description
    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
    Time Frame
    Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
    Title
    Depression
    Description
    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).
    Time Frame
    Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, minimum six months follow up
    Title
    Insomnia
    Description
    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
    Time Frame
    Pre-treatment, 1 week post, minimum nine weeks after pre-treatment, six months follow up
    Title
    Client satisfaction
    Description
    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.
    Time Frame
    1 week post Concentrated Exposure Treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gerd Kvale, PhD
    Organizational Affiliation
    Haukeland UH
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gunvor Launes, MD
    Organizational Affiliation
    Sorlandet Hospital HF
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31803089
    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.
    Results Reference
    derived

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

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