NCT00358995

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

5.2 years

First QC Date

July 28, 2006

Last Update Submit

February 17, 2014

Conditions

Keywords

Cognitive Behavioral TherapyPrimary ObsessionsObsessive Compulsive DisorderCompulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • 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).

    12 months

Study Arms (2)

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

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)

Interventions

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.

1

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Hospital, The Anxiety Disorders Clinic

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive DisorderCompulsive Personality Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersPersonality Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Peter McLean, MD

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

July 1, 2002

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations