Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Narrative therapy, Group therapy
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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
This study only has one arm; all patients receive the treatment intervention.
Outcomes
Primary Outcome Measures
YBOCS Change
Yale Brown Obsessive Compulsive Scale
Secondary Outcome Measures
BDI-II Change
Beck Depression Inventory
QOLS Change
Quality Of Life Scale
Functions of Identity Scale Change
Examines aspects of identity
Social Connectedness Scale Change
Measure of sense of social connectedness
Full Information
NCT ID
NCT04154085
First Posted
November 2, 2019
Last Updated
October 28, 2022
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04154085
Brief Title
Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
Official Title
Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
September 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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. 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.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Narrative therapy, Group therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A group consisting of 12-15 participants will be recruited for this initial exploratory study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
This study only has one arm; all patients receive the treatment intervention.
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Intervention Description
Group psychotherapy
Primary Outcome Measure Information:
Title
YBOCS Change
Description
Yale Brown Obsessive Compulsive Scale
Time Frame
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Secondary Outcome Measure Information:
Title
BDI-II Change
Description
Beck Depression Inventory
Time Frame
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Title
QOLS Change
Description
Quality Of Life Scale
Time Frame
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Title
Functions of Identity Scale Change
Description
Examines aspects of identity
Time Frame
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Title
Social Connectedness Scale Change
Description
Measure of sense of social connectedness
Time Frame
Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
9245296
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
24818457
Citation
Dembo JS. "The ickiness factor:" case study of an unconventional psychotherapeutic approach to pediatric OCD. Am J Psychother. 2014;68(1):57-79. doi: 10.1176/appi.psychotherapy.2014.68.1.57.
Results Reference
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PubMed Identifier
15966948
Citation
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. doi: 10.1111/j.1744-6171.2005.00012.x.
Results Reference
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PubMed Identifier
25968420
Citation
Goncalves 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.
Results Reference
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PubMed Identifier
21331976
Citation
Goncalves 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. No abstract available.
Results Reference
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PubMed Identifier
2684084
Citation
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. doi: 10.1001/archpsyc.1989.01810110048007.
Results Reference
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PubMed Identifier
29851880
Citation
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.
Results Reference
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Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
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