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

Anxiety Disorders Clinical Trial

Official title:

A Randomized Trial Testing the Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01953042
• Other study ID #: 279-2013
• Status: Withdrawn
• Phase: N/A
• Start date: September 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2018
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Psychoeducation
4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Secondary	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.	4 months