Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder

October 28, 2022 updated by: Justine Dembo, Sunnybrook Health Sciences Centre
This is a prospective exploratory study using narrative therapy in group format, over 20 sessions, 2 hours per session, weekly, to determine whether this modality can provide any benefit to OCD symptoms, mood, sense of social connectedness, sense of identity, and/or quality of life in individuals living with treatment-resistant OCD. NOTE: an amendment is now in place so that the group can occur virtually given the COVID pandemic; Zoom will be used as our platform.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many patients referred to the Thompson Centre at Sunnybrook have severe OCD, and have significant and disabling symptoms even after completing our treatment protocols, including our intensive and residential programs. These patients have already undergone traditional cognitive behavioural therapy (CBT) and exposure and response prevention (ERP), as well as pharmacotherapy. Patients voice distress at their poor quality of life and high symptom burden, and can feel hopeless, if they have exhausted numerous evidence-based treatment options without significant improvement. Narrative therapy is a unique approach, based on the premise that language reflects a social construction of reality. Individuals with severe mental illness hold within themselves life narratives that reinforce their painful beliefs about themselves, the world, and others. Evidence indicates that narrative therapy can help to create a more cohesive identity and a more flexible view of the self and the future.

Our primary goal is to determine whether narrative therapy could improve OCD symptom burden and quality of life in a highly treatment-resistant population. Domains such as mood, identity, and interpersonal connectedness are secondary measures. The research questions are: could narrative therapy lead to symptomatic improvement in treatment-resistant OCD? And could narrative therapy improve the domains of mood, interpersonal connectedness, and/or identity in patients with treatment-resistant OCD?

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to speak and write fluently in English.
  • Patients who have participated in the intensive/residential program or group programs and/or have received pharmacotherapy with a psychiatrist at the Frederick W. Thomspon Anxiety Disorder Centre
  • Patients between the ages of 18-65
  • Only patients who have treatment-resistant OCD are eligible. For the purposes of this study we are defining this as: failure to achieve remission after having tried 1) At least two first-line SSRI's AND either clomipramine or atypical antipsychotic augmentation, and 2) at least one full course of exposure and response prevention (ERP), or our intensive/residential program.

Exclusion Criteria:

  • those with active substance abuse/dependence within three months
  • suspected organic pathology
  • recent suicide attempt/active suicidality
  • current self-injurious behaviour
  • active bipolar or psychotic disorder
  • history of aggression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
This study only has one arm; all patients receive the treatment intervention.
Other: Psychotherapy
Group psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
YBOCS Change
Time Frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Yale Brown Obsessive Compulsive Scale
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BDI-II Change
Time Frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Beck Depression Inventory
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
QOLS Change
Time Frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Quality Of Life Scale
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Functions of Identity Scale Change
Time Frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Examines aspects of identity
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Social Connectedness Scale Change
Time Frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Measure of sense of social connectedness
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

September 2, 2021

Study Registration Dates

First Submitted

November 2, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4136016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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