Obsessive-Compulsive DisorderNCT01953042
Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
A study testing Psychoeducation in people with Obsessive-Compulsive Disorder and Anxiety Disorders, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study will examine the effect of offering information sessions to a randomized group of patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment; though intended to be informative in nature, these psychoeducation services can have a positive effect on quality of life, sense of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obsessive-Compulsive Disorder, Anxiety Disorders
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Mar 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre
- Presenting with OCD or OCD Spectrum Disorders
- Ability to communicate in written and spoken English
Who cannot join
- Active substance abuse/dependence
- Suspected organic pathology
- Recent suicide attempt/active suicideality
- Active bipolar or psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Testing the Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
This study will examine the effect of offering information sessions to a randomized group of patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment; though intended to be informative in nature, these psychoeducation services can have a positive effect on quality of life, sense of self-efficacy, functioning and a person's readiness to engage in long term treatment. However, no studies have dismantled and tested the independent effect of psychoeducation from standard treatment such as Cognitive Behavioural Therapy. This study aims to directly test the potential effect of one aspect of CBT that if found to be helpful, can become a distinct early intervention component of care so that as people await services, they can profit from the early benefits associated with attending these information sessions. This study therefore sets out to examine the potential early benefits of providing education about the illness on symptom functioning, quality of life and readiness to engage in more formal treatment. We will offer 4 structured information sessions to individuals allocated to a wait list for services related to the treatment of OCD and OCD Spectrum Disorders in order to directly test the benefit of adding a didactic structured psychoeducation program to our services. The study will be a randomized trial where subjects (N=50) will be randomly assigned to receive either 1) 4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders or 2) wait list as per usual with no additional information sessions. The experimental design is a 2 (treatment condition) by 2 (assessment phase) repeated measures factorial design. It is hypothesized that subjects participating in the psychoeducation group compared to the wait list control group will see greater reductions in self-reported measures of symptom severity and improvement in other measures of quality of life, level of functioning, self-efficacy and readiness to engage in treatment. If this study can demonstrate that the addition of a short structured informative intervention of 4 sessions can confer early benefits for those suffering with OCD and OCD spectrum disorders, then it provides another route by which patients can improve this condition specifically while waiting for consultation and the opportunity to receive a more structured, evidence-based treatment.
- Conditions
- Obsessive-Compulsive Disorder, Anxiety Disorders
- Being tested
- Psychoeducation
- Keywords
- Obsessive-Compulsive Disorder, Health Education
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders
| Study group | Role | What they receive |
|---|---|---|
| Waitlist as Per Usual | No intervention | Wait list as per usual with no additional information sessions |
| Waitlist and Psychoeducation | Active comparator | Patients remain on waitlist but also receive 4 additional educational sessions (8 hours each) Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptom Severity from Baseline in OCD and Spectrum Measures
OCD measures will include the 18-item Obsessive Compulsive Inventory-Revised (OCI-R), measuring subscales of Washing, Checking, Doubting, Ordering, Obsessions, Hoarding and Neutralizing, as well as a self-report version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS-SR), a 3 part questionnaire containing a 58 item symptom checklist, identification of the most prominent obsessions and compulsions and a 10 item severity scale. OCD Spectrum measures will include the Body Dysmorphic Disorder-YBOCS, Savings Inventory Revised, PITS, and the MGH scale.
Measured: 4 months
Secondary outcomes (1)
Change in Quality of Life from Baseline
Measures capturing quality of life, level of impairment, self-efficacy, and readiness to change will include the Quality of Life Enjoyment Questionnaire (Q-LES-Q-SF), the Sheehan Disability Scale, the Illness Intrusiveness Rating Scale (III), the University of Rhode Island Change Assessment (URICA), the SF-36, and the COPE Scale.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Lack of dedicated resources at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Neil Rector, Sunnybrook Health Sciences Centre
- Investigators
- Neil A Rector, Ph.D., C.Psych., Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953042
- Sponsor's protocol ID
- 279-2013
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2013
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Testing the Benefits of a Psychoeducation Program for Those Awaiting Treatment for OCD and OCD Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01953042
- Acronym / sponsor ID
- 279-2013
- Conditions
- Obsessive-Compulsive Disorder, Anxiety Disorders
- Keywords
- Obsessive-Compulsive Disorder, Health Education
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of dedicated resources at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Sep 2013 (estimated)
- 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 study will examine the effect of offering information sessions to a randomized group of patients with OCD spectrum disorders. Psychoeducation is a component of first line treatment; though intended to be informative in nature, these psychoeducation services can have a positive effect on quality of life, sense of self-efficacy, functioning and a person's readiness to engage in long term treatment. However, no studies have dismantled and tested the independent effect of psychoeducation from standard treatment such as Cognitive Behavioural Therapy. This study aims to directly test the potential effect of one aspect of CBT that if found to be helpful, can become a distinct early intervention component of care so that as people await services, they can profit from the early benefits associated with attending these information sessions. This study therefore sets out to examine the potential early benefits of providing education about the illness on symptom functioning, quality of life and readiness to engage in more formal treatment. We will offer 4 structured information sessions to individuals allocated to a wait list for services related to the treatment of OCD and OCD Spectrum Disorders in order to directly test the benefit of adding a didactic structured psychoeducation program to our services. The study will be a randomized trial where subjects (N=50) will be randomly assigned to receive either 1) 4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders or 2) wait list as per usual with no additional information sessions. The experimental design is a 2 (treatment condition) by 2 (assessment phase) repeated measures factorial design. It is hypothesized that subjects participating in the psychoeducation group compared to the wait list control group will see greater reductions in self-reported measures of symptom severity and improvement in other measures of quality of life, level of functioning, self-efficacy and readiness to engage in treatment. If this study can demonstrate that the addition of a short structured informative intervention of 4 sessions can confer early benefits for those suffering with OCD and OCD spectrum disorders, then it provides another route by which patients can improve this condition specifically while waiting for consultation and the opportunity to receive a more structured, evidence-based treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist as Per Usual | No intervention | –Wait list as per usual with no additional information sessions |
| Waitlist and Psychoeducation | Active comparator | Behavioral: PsychoeducationPatients remain on waitlist but also receive 4 additional educational sessions (8 hours each) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre
- Presenting with OCD or OCD Spectrum Disorders
- Ability to communicate in written and spoken English
Key exclusion criteria (4 listed)
- Active substance abuse/dependence
- Suspected organic pathology
- Recent suicide attempt/active suicideality
- 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 |
|---|---|---|
| Psychoeducation4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders | Behavioural | Waitlist and Psychoeducation |
Primary outcome
Change in Symptom Severity from Baseline in OCD and Spectrum Measures
Time frame: 4 months
OCD measures will include the 18-item Obsessive Compulsive Inventory-Revised (OCI-R), measuring subscales of Washing, Checking, Doubting, Ordering, Obsessions, Hoarding and Neutralizing, as well as a self-report version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS-SR), a 3 part questionnaire containing a 58 item symptom checklist, identification of the most prominent obsessions and compulsions and a 10 item severity scale. OCD Spectrum measures will include the Body Dysmorphic Disorder-YBOCS, Savings Inventory Revised, PITS, and the MGH scale.
1 secondary outcome
Change in Quality of Life from Baseline
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- 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.
Neil A Rector, Ph.D., C.Psych. principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Obsessive-Compulsive Disorder and Anxiety Disorders, 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 6 Sep 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Symptom Severity from Baseline in OCD and Spectrum Measures (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2018.