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Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders

Primary Purpose

Obsessive-Compulsive Disorder, Anxiety Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Health Education

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre
  • Presenting with OCD or OCD Spectrum Disorders
  • Ability to communicate in written and spoken English

Exclusion Criteria:

  • Active substance abuse/dependence
  • Suspected organic pathology
  • Recent suicide attempt/active suicideality
  • Active bipolar or psychotic disorder

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Waitlist as Per Usual

Waitlist and Psychoeducation

Arm Description

Wait list as per usual with no additional information sessions

Patients remain on waitlist but also receive 4 additional educational sessions (8 hours each)

Outcomes

Primary Outcome Measures

Change in Symptom Severity from Baseline in OCD and Spectrum Measures
OCD measures will include the 18-item Obsessive Compulsive Inventory-Revised (OCI-R), measuring subscales of Washing, Checking, Doubting, Ordering, Obsessions, Hoarding and Neutralizing, as well as a self-report version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS-SR), a 3 part questionnaire containing a 58 item symptom checklist, identification of the most prominent obsessions and compulsions and a 10 item severity scale. OCD Spectrum measures will include the Body Dysmorphic Disorder-YBOCS, Savings Inventory Revised, PITS, and the MGH scale.

Secondary Outcome Measures

Change in Quality of Life from Baseline
Measures capturing quality of life, level of impairment, self-efficacy, and readiness to change will include the Quality of Life Enjoyment Questionnaire (Q-LES-Q-SF), the Sheehan Disability Scale, the Illness Intrusiveness Rating Scale (III), the University of Rhode Island Change Assessment (URICA), the SF-36, and the COPE Scale.

Full Information

First Posted
September 25, 2013
Last Updated
September 4, 2018
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01953042
Brief Title
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
Official Title
A Randomized Trial Testing the Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of dedicated resources at this time.
Study Start Date
September 2013 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will examine the effect of offering information sessions to a randomized group of patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment; though intended to be informative in nature, these psychoeducation services can have a positive effect on quality of life, sense of self-efficacy, functioning and a person's readiness to engage in long term treatment. However, no studies have dismantled and tested the independent effect of psychoeducation from standard treatment such as Cognitive Behavioural Therapy. This study aims to directly test the potential effect of one aspect of CBT that if found to be helpful, can become a distinct early intervention component of care so that as people await services, they can profit from the early benefits associated with attending these information sessions. This study therefore sets out to examine the potential early benefits of providing education about the illness on symptom functioning, quality of life and readiness to engage in more formal treatment. We will offer 4 structured information sessions to individuals allocated to a wait list for services related to the treatment of OCD and OCD Spectrum Disorders in order to directly test the benefit of adding a didactic structured psychoeducation program to our services. The study will be a randomized trial where subjects (N=50) will be randomly assigned to receive either 1) 4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders or 2) wait list as per usual with no additional information sessions. The experimental design is a 2 (treatment condition) by 2 (assessment phase) repeated measures factorial design. It is hypothesized that subjects participating in the psychoeducation group compared to the wait list control group will see greater reductions in self-reported measures of symptom severity and improvement in other measures of quality of life, level of functioning, self-efficacy and readiness to engage in treatment. If this study can demonstrate that the addition of a short structured informative intervention of 4 sessions can confer early benefits for those suffering with OCD and OCD spectrum disorders, then it provides another route by which patients can improve this condition specifically while waiting for consultation and the opportunity to receive a more structured, evidence-based treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, Anxiety Disorders
Keywords
Obsessive-Compulsive Disorder, Health Education

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Waitlist as Per Usual
Arm Type
No Intervention
Arm Description
Wait list as per usual with no additional information sessions
Arm Title
Waitlist and Psychoeducation
Arm Type
Active Comparator
Arm Description
Patients remain on waitlist but also receive 4 additional educational sessions (8 hours each)
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders
Primary Outcome Measure Information:
Title
Change in Symptom Severity from Baseline in OCD and Spectrum Measures
Description
OCD measures will include the 18-item Obsessive Compulsive Inventory-Revised (OCI-R), measuring subscales of Washing, Checking, Doubting, Ordering, Obsessions, Hoarding and Neutralizing, as well as a self-report version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS-SR), a 3 part questionnaire containing a 58 item symptom checklist, identification of the most prominent obsessions and compulsions and a 10 item severity scale. OCD Spectrum measures will include the Body Dysmorphic Disorder-YBOCS, Savings Inventory Revised, PITS, and the MGH scale.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life from Baseline
Description
Measures capturing quality of life, level of impairment, self-efficacy, and readiness to change will include the Quality of Life Enjoyment Questionnaire (Q-LES-Q-SF), the Sheehan Disability Scale, the Illness Intrusiveness Rating Scale (III), the University of Rhode Island Change Assessment (URICA), the SF-36, and the COPE Scale.
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre Presenting with OCD or OCD Spectrum Disorders Ability to communicate in written and spoken English Exclusion Criteria: Active substance abuse/dependence Suspected organic pathology Recent suicide attempt/active suicideality Active bipolar or psychotic disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil A Rector, Ph.D., C.Psych.
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders

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