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Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154085
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Justine Dembo, Sunnybrook Health Sciences Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Other: Psychotherapy Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A group consisting of 12-15 participants will be recruited for this initial exploratory study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
Estimated Study Start Date : January 2, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : January 2, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154085


Contacts
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Contact: Justine S Dembo, MD (416) 480-6736 justine.dembo@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Contact: Justine S Dembo, MD    (416) 480-6736    justine.dembo@sunnybrook.ca   
Principal Investigator: Justine S Dembo, MD         
Sub-Investigator: Lance Hawley, PhD         
Sub-Investigator: Margaret A Richter, MD         
Sub-Investigator: Renato Ramos, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Publications:

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Responsible Party: Justine Dembo, Psychiatrist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04154085    
Other Study ID Numbers: 4136016
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Justine Dembo, Sunnybrook Health Sciences Centre:
Narrative therapy
Group therapy
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders