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

NCT01953042 | Withdrawn DMC

• 1 other identifier: 279-2013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders

Keywords

Obsessive-Compulsive Disorder; Health Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Quality of Life from Baseline

  4 months

Study Arms (2)

Waitlist as Per Usual

NO INTERVENTION

Wait list as per usual with no additional information sessions

Waitlist and Psychoeducation

ACTIVE COMPARATOR

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

Behavioral: Psychoeducation

Interventions

Psychoeducation BEHAVIORAL

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

Waitlist and Psychoeducation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders; Health Education

Condition Hierarchy (Ancestors)

Mental Disorders; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Neil A Rector, Ph.D., C.Psych.

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist, Psychologist, and Director of the Mood and Anxiety Treatment and Research Program

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: September 30, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)