NCT04154085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 2, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2021

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

November 2, 2019

Last Update Submit

October 28, 2022

Conditions

Keywords

Narrative therapyGroup therapy

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • BDI-II Change

    Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment

  • QOLS Change

    Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment

  • Functions of Identity Scale Change

    Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment

  • Social Connectedness Scale Change

    Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment

Study Arms (1)

Study Group

EXPERIMENTAL

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

Other: Psychotherapy

Interventions

Group psychotherapy

Study Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (8)

  • 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.

    PMID: 9245296BACKGROUND
  • 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.

    PMID: 28598984BACKGROUND
  • 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.

    PMID: 24818457BACKGROUND
  • 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.

    PMID: 15966948BACKGROUND
  • 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.

    PMID: 25968420BACKGROUND
  • 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.

    PMID: 21331976BACKGROUND
  • 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.

    PMID: 2684084BACKGROUND
  • 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.

    PMID: 29851880BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A group consisting of 12-15 participants will be recruited for this initial exploratory study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 6, 2019

Study Start

January 2, 2021

Primary Completion

August 1, 2021

Study Completion

September 2, 2021

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations