Narrative Therapy for Treatment-Resistant Obsessive-Compu... | NCT04154085

Studies
Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder

NCT04154085

Sponsor

Sunnybrook Health Sciences Centre

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Obsessive-Compulsive Disorder

Interventions

Psychotherapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2021Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Sep 2, 2021Actual

First Submitted Date

Nov 2, 2019

First Submission Date that Met QC Criteria

Nov 4, 2019

First Posted Date

Nov 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	This study only has one arm; all patients receive the treatment intervention.	Other: Psychotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychotherapy	Other	Group psychotherapy	Study Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
BDI-II Change	Beck Depression Inventory	Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
QOLS Change	Quality Of Life Scale

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre		Toronto	Ontario	M4N3M5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9245296	Background	Adams GR, Marshall SK. A developmental social psychology of identity: understanding the person-in-context. J Adolesc. 1996 Oct;19(5):429-42. doi: 10.1006/jado.1996.0041.
28598984	Background	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.

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders