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A Cognitive Behavioral Therapy of Primary Obsessions in Obsessive Compulsive Disorder

Primary Purpose

Obsessive Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Stress Management Therapy (SMT)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Cognitive Behavioral Therapy, Primary Obsessions, Obsessive Compulsive Disorder, Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: involves: a primary diagnosis of OCD, an absence of overt compulsions associated with the primary obsessions, functional impairment due to OCD for at least one year, age range 18-65 years, fluency in spoken and written English, a willingness to undergo random assignment to treatment, and to complete the assigned treatment and planned assignments. Exclusion Criteria: presence of a severe depressive disorder with suicidal intent requiring immediate intervention, evidence of organic mental disorder, active thought disorder, current alcohol or drug dependence, or mental retardation, concurrent psychological treatment for any axis (i) or (ii) disorder, aside from supportive therapy for depression, and commencement or change in psychotropic medication in the three months prior to initial assessment through to post-treatment assessment.

Sites / Locations

  • UBC Hospital, The Anxiety Disorders Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Cognitive Behavior Therapy (CBT) may include keeping a diary of significant events and associated feelings, thoughts and behaviors; questioning and testing cognitions, assumptions, evaluations and beliefs that might be unhelpful and unrealistic; gradually facing activities which may have been avoided; and trying out new ways of behaving and reacting and using relaxation and distraction techniques.

Stress Management Therapy (SMT) includes relaxation, interaction, biofeedback, exercises, such as muscle stretching exercises, yoga, meditation, time management techniques, and many more.

Outcomes

Primary Outcome Measures

The primary outcome of the study is to determine if CBT is more effective than SMT in reducing distorted beliefs and OCD symptoms in study participants post treatment, as well as six and twelve months post treatment.

Secondary Outcome Measures

The secondary outcome of the study is to determine if change in appraisals of intrusive thoughts will mediate symptom change during and after treatment (i.e. follow-up).

Full Information

First Posted
July 28, 2006
Last Updated
February 17, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00358995
Brief Title
A Cognitive Behavioral Therapy of Primary Obsessions in Obsessive Compulsive Disorder
Official Title
A New Cognitive Behavioral Therapy to Target Distorted Appraisals Characteristic of Primary Obsessions in Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A New Cognitive Behavioral Therapy to Target Distorted Appraisals Characteristic of Primary Obsessions in Obsessive Compulsive Disorder
Detailed Description
Participants will be phone-screened to determine broad suitability and interest in being in the study, as well as availability. Following telephone screening, participants will meet with a clinician who will administer a semi-structured interview to determine diagnostic status followed by a more specific standard semi-structured interview to measure symptom strength in those participants who meet diagnostic criteria of OCD (primary obsessions). Participants will then be invited to join the study. Participants will be randomly assigned to either immediate treatment or delayed treatment (three month delay). Participants will then be again be randomly assigned to either Cognitive Behavior Therapy (CBT) or Stress Management Therapy (SMT). The delayed participants (wait list control) will be randomly assigned to either of the two active treatment groups in three months time. Both active treatment conditions involve one hours, individual treatment sessions for 12 consecutive weeks by one of the treating psychologists. All participants will also be asked to complete a package of psychometric questionnaires before treatment. Participants assigned to the delayed treatment condition will be asked to complete these questionnaires again before proceeding to treatment once they have completed the three month wait. The participants will be re-evaluated at the end of treatment, at six months after treatment, and at one year after treatment, using the same assessment procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Cognitive Behavioral Therapy, Primary Obsessions, Obsessive Compulsive Disorder, Compulsive Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Cognitive Behavior Therapy (CBT) may include keeping a diary of significant events and associated feelings, thoughts and behaviors; questioning and testing cognitions, assumptions, evaluations and beliefs that might be unhelpful and unrealistic; gradually facing activities which may have been avoided; and trying out new ways of behaving and reacting and using relaxation and distraction techniques.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Stress Management Therapy (SMT) includes relaxation, interaction, biofeedback, exercises, such as muscle stretching exercises, yoga, meditation, time management techniques, and many more.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Participants will be randomly assigned to either immediate treatment or delayed treatment (three month delay). Participants will then be again be randomly assigned to either Cognitive Behavior Therapy (CBT) or Stress Management Therapy (SMT). The delayed participants (wait list control) will be randomly assigned to either of the two active treatment groups in three months time. Both active treatment conditions involve one hours, individual treatment sessions for 12 consecutive weeks by one of the treating psychologists. All participants will also be asked to complete a package of psychometric questionnaires before treatment.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Therapy (SMT)
Intervention Description
Participants will be randomly assigned to either immediate treatment or delayed treatment (three month delay). Participants will then be again be randomly assigned to either Cognitive Behavior Therapy (CBT) or Stress Management Therapy (SMT). The delayed participants (wait list control) will be randomly assigned to either of the two active treatment groups in three months time. Both active treatment conditions involve one hours, individual treatment sessions for 12 consecutive weeks by one of the treating psychologists. All participants will also be asked to complete a package of psychometric questionnaires before treatment.
Primary Outcome Measure Information:
Title
The primary outcome of the study is to determine if CBT is more effective than SMT in reducing distorted beliefs and OCD symptoms in study participants post treatment, as well as six and twelve months post treatment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The secondary outcome of the study is to determine if change in appraisals of intrusive thoughts will mediate symptom change during and after treatment (i.e. follow-up).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: involves: a primary diagnosis of OCD, an absence of overt compulsions associated with the primary obsessions, functional impairment due to OCD for at least one year, age range 18-65 years, fluency in spoken and written English, a willingness to undergo random assignment to treatment, and to complete the assigned treatment and planned assignments. Exclusion Criteria: presence of a severe depressive disorder with suicidal intent requiring immediate intervention, evidence of organic mental disorder, active thought disorder, current alcohol or drug dependence, or mental retardation, concurrent psychological treatment for any axis (i) or (ii) disorder, aside from supportive therapy for depression, and commencement or change in psychotropic medication in the three months prior to initial assessment through to post-treatment assessment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter McLean, MD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UBC Hospital, The Anxiety Disorders Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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A Cognitive Behavioral Therapy of Primary Obsessions in Obsessive Compulsive Disorder

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