A Cognitive Behavioral Therapy of Primary Obsessions in Obsessive Compulsive Disorder

February 17, 2014 updated by: University of British Columbia

A New Cognitive Behavioral Therapy to Target Distorted Appraisals Characteristic of Primary Obsessions in Obsessive Compulsive Disorder

A New Cognitive Behavioral Therapy to Target Distorted Appraisals Characteristic of Primary Obsessions in Obsessive Compulsive Disorder

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • UBC Hospital, The Anxiety Disorders Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

involves:

  1. a primary diagnosis of OCD,
  2. an absence of overt compulsions associated with the primary obsessions,
  3. functional impairment due to OCD for at least one year,
  4. age range 18-65 years,
  5. fluency in spoken and written English,
  6. a willingness to undergo random assignment to treatment, and to complete the assigned treatment and planned assignments.

Exclusion Criteria:

  1. presence of a severe depressive disorder with suicidal intent requiring immediate intervention,
  2. evidence of organic mental disorder, active thought disorder, current alcohol or drug dependence, or mental retardation,
  3. concurrent psychological treatment for any axis (i) or (ii) disorder, aside from supportive therapy for depression, and
  4. commencement or change in psychotropic medication in the three months prior to initial assessment through to post-treatment assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
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.
Behavioral: Cognitive Behavioral Therapy
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.
ACTIVE_COMPARATOR: 2
Stress Management Therapy (SMT) includes relaxation, interaction, biofeedback, exercises, such as muscle stretching exercises, yoga, meditation, time management techniques, and many more.
Behavioral: Stress Management Therapy (SMT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Peter McLean, MD, The University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (ESTIMATE)

August 1, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H02-80132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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