A Cognitive Behavioral Therapy of Primary Obsessions in Obsessive Compulsive Disorder - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00358995

Purpose

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

Condition	Intervention
Obsessive Compulsive Disorder	Behavioral: Cognitive Behavioral Therapy Behavioral: Stress Management Therapy (SMT)

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A New Cognitive Behavioral Therapy to Target Distorted Appraisals Characteristic of Primary Obsessions in Obsessive Compulsive Disorder

Further study details as provided by University of British Columbia:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2002
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.

Arms

Assigned Interventions

1: Active Comparator

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.

2: Active Comparator

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358995

Locations

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

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Peter McLean, MD

The University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Peter McLean )
Study ID Numbers:	B02-0132
Study First Received:	July 28, 2006
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00358995
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Cognitive Behavioral Therapy
Primary Obsessions
Obsessive Compulsive Disorder
Compulsive Disorder

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Obsessive Behavior
Obsessive-Compulsive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009