Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder

• ClinicalTrials.gov Identifier: NCT04154085
• Recruitment Status: Not yet recruiting
• First Posted: November 6, 2019
• Last Update Posted: November 6, 2019
• Sponsor: Sunnybrook Health Sciences Centre
• Information provided by (Responsible Party): Justine Dembo, Sunnybrook Health Sciences Centre

Tracking Information

• First Submitted Date: November 2, 2019
• First Posted Date: November 6, 2019
• Last Update Posted Date: November 6, 2019
• Estimated Study Start Date: January 2, 2020
• Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 4, 2019)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 4, 2019)

• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
• Official Title: Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
• 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.

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
• Study Phase: Not Applicable

Study Design

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

• Condition: Obsessive-Compulsive Disorder

Intervention

Other: Psychotherapy

Group psychotherapy

Study Arms

Experimental: Study Group

This study only has one arm; all patients receive the treatment intervention.

Intervention: Other: Psychotherapy

Publications *

• Adams GR, Marshall SK. A developmental social psychology of identity: understanding the person-in-context. J Adolesc. 1996 Oct;19(5):429-42.
• Cordier R, Milbourn B, Martin R, Buchanan A, Chung D, Speyer R. A systematic review evaluating the psychometric properties of measures of social inclusion. PLoS One. 2017 Jun 9;12(6):e0179109. doi: 10.1371/journal.pone.0179109. eCollection 2017. Review.
• Dembo JS. "The ickiness factor:" case study of an unconventional psychotherapeutic approach to pediatric OCD. Am J Psychother. 2014;68(1):57-79.
• DeSocio JE. Accessing self-development through narrative approaches in child and adolescent psychotherapy. J Child Adolesc Psychiatr Nurs. 2005 Apr-Jun;18(2):53-61. Review.
• Gonçalves MM, Ribeiro AP, Silva JR, Mendes I, Sousa I. Narrative innovations predict symptom improvement: Studying innovative moments in narrative therapy of depression. Psychother Res. 2016 Jul;26(4):425-35. doi: 10.1080/10503307.2015.1035355. Epub 2015 May 13.
• Gonçalves MM, Stiles WB. Narrative and psychotherapy: introduction to the special section. Psychother Res. 2011 Jan;21(1):1-3. doi: 10.1080/10503307.2010.534510.
• Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11.
• Richter PMA, Ramos RT. Obsessive-Compulsive Disorder. Continuum (Minneap Minn). 2018 Jun;24(3, BEHAVIORAL NEUROLOGY AND PSYCHIATRY):828-844. doi: 10.1212/CON.0000000000000603. Review.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: November 4, 2019): 12
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2, 2021
• Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT04154085
• Other Study ID Numbers: 4136016
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Justine Dembo, Sunnybrook Health Sciences Centre
• Study Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sunnybrook Health Sciences Centre
• Verification Date: November 2019