Obsessive-Compulsive DisorderNCT04154085
Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
A study testing Psychotherapy in people with Obsessive-Compulsive Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2021to 2 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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?
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Psychotherapy
- Keywords
- Narrative therapy, Group therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
Group psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | This study only has one arm; all patients receive the treatment intervention. Receives: Other: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
YBOCS Change
Yale Brown Obsessive Compulsive Scale
Measured: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Secondary outcomes (4)
BDI-II Change
Beck Depression Inventory
Measured: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
QOLS Change
Quality Of Life Scale
Measured: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Functions of Identity Scale Change
Examines aspects of identity
Measured: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Social Connectedness Scale Change
Measure of sense of social connectedness
Measured: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start2 Jan 2021
- Primary completion1 Aug 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A group consisting of 12-15 participants will be recruited for this initial exploratory study.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justine Dembo, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154085
- Sponsor's protocol ID
- 4136016
- Status last verified
- Oct 2022
- First submitted
- 2 Nov 2019
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9245296Cordier 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.
PubMed 28598984Dembo 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.
PubMed 24818457DeSocio 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.
PubMed 15966948Goncalves 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.
PubMed 25968420Goncalves 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.
PubMed 21331976Goodman 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.
PubMed 2684084Richter PMA, Ramos RT. Obsessive-Compulsive Disorder. Continuum (Minneap Minn). 2018 Jun;24(3, BEHAVIORAL NEUROLOGY AND PSYCHIATRY):828-844. doi: 10.1212/CON.0000000000000603.
PubMed 29851880
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT04154085
- Acronym / sponsor ID
- 4136016
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Narrative therapy, Group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A group consisting of 12-15 participants will be recruited for this initial exploratory study.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: PsychotherapyThis study only has one arm; all patients receive the treatment intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyGroup psychotherapy | Other | Study Group |
Primary outcome
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
4 secondary outcomes
BDI-II Change
Time frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
QOLS Change
Time frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
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
Social Connectedness Scale Change
Time frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 9245296Adams 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.
- Background: PubMed 28598984Cordier 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.
- Background: PubMed 24818457Dembo 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.
- Background: PubMed 15966948DeSocio 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.
- Background: PubMed 25968420Goncalves 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.
- Background: PubMed 21331976Goncalves 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.
- Background: PubMed 2684084Goodman 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.
- Background: PubMed 29851880Richter PMA, Ramos RT. Obsessive-Compulsive Disorder. Continuum (Minneap Minn). 2018 Jun;24(3, BEHAVIORAL NEUROLOGY AND PSYCHIATRY):828-844. doi: 10.1212/CON.0000000000000603.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Obsessive-Compulsive Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YBOCS Change (time frame: Prior to start; at 5 weeks, 10 weeks, 15 weeks, and 20 weeks; then 12 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04154085, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.