A Cognitive Behavioral Therapy of Primary Obsessions in Obsessive Compulsive Disorder

NCT ID: NCT00358995

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2007-09-30

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.

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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.

2

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

Group Type: ACTIVE_COMPARATOR

Stress Management Therapy (SMT)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter McLean, MD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

UBC Hospital, The Anxiety Disorders Clinic

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H02-80132

Identifier Type: -

Identifier Source: org_study_id