Obsessive-Compulsive DisorderNCT02909660
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
A study testing Cognitive-behavioural therapy in people with Obsessive-Compulsive Disorder, run by Concordia University, Montreal at 1 site in Canada.
Trial summary
This study evaluates the efficacy and acceptability of two cognitive-behavioural interventions for reassurance seeking behaviour in obsessive-compulsive disorder (OCD), a family accommodation reduction protocol vs. a novel support-seeking protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive-behavioural therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Nov 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OCD
- Engaging in reassurance seeking more than once a day about the same thing
- Willingness to allow the experimenter to contact a significant other from whom the participant seeks reassurance regularly
- Ability to read, write, and communicate in English
Who cannot join
- Current suicidal ideation/intent
- Current substance abuse
- Psychosis
- Diagnosis of bipolar disorder (I or II)
- If participants are on medication they must be on a stable dose (i.e., have maintained a consistent dose for at least three months) and agree not to change their medication regimen for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy and acceptability of two cognitive-behavioural interventions for reassurance seeking behaviour in obsessive-compulsive disorder (OCD), a family accommodation reduction protocol vs. a novel support-seeking protocol. Half of participants will be randomly assigned to participate in the support-seeking intervention, whereas the other half will participate in the family accommodation reduction intervention.
Read the detailed description
An existing family accommodation reduction intervention to reduce reassurance seeking behaviour in OCD (which represents treatment as usual, or TAU) is being compared to a novel support-seeking intervention to determine which is more efficacious and acceptable to participants.
The TAU protocol asks participants to make an agreement with their significant others to withhold reassurance when it is sought. It is believed that this behaviourally-based intervention encourages extinction of reassurance seeking over time by eliminating reinforcement of the behaviour by significant others.
The support-seeking intervention asks participants to move towards adaptively seeking support from a significant other to manage anxiety or distress rather than seeking reassurance. Significant others are taught to provide support rather than reassurance. It is believed that support-seeking may reduce reassurance seeking behaviour because it helps participants manage the anxiety or distress that underlies the requests for reassurance without interfering with disconfirmatory learning.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Cognitive-behavioural 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.
Cognitive-behavioural therapyOther
Empirically-supported psychological intervention for various mental health concerns including obsessive-compulsive disorder (OCD). Includes components to foster cognitive (i.e., thinking) and behavioural changes.
| Study group | Role | What they receive |
|---|---|---|
| Support-seeking intervention | Experimental | Cognitive-behavioural therapy intervention that guides participants to seek support rather than reassurance; participants' significant others are asked to provide support rather than reassurance. Receives: Other: Cognitive-behavioural therapy |
| Family accommodation reduction intervention | Active comparator | Cognitive-behavioural therapy intervention that guides participants' significant others to withhold reassurance when it is requested; participants are asked to refrain from seeking reassurance. Receives: Other: Cognitive-behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported reassurance seeking behaviour
Number of times participants self-report seeking reassurance per day
Measured: 5 weeks (baseline through 3 week follow-up)
Self-reported support-seeking behaviour
Number of times participants in the support-seeking condition self-report seeking reassurance per day
Measured: 4 weeks (condition assignment through 3 week follow-up)
Self-reported anxiety
Level of anxiety on average per day, self-rated from 0-100
Measured: 5 weeks (baseline monitoring through 3 week follow-up)
One-week follow-up: Treatment Acceptability and Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)
Validated questionnaire assessing how acceptable participants find an intervention as well as ease of adherence.
Measured: One-week follow-up
One-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)
Validated questionnaire assessing acceptability of and discomfort caused by an intervention.
Measured: One-week follow-up
Three-week follow-up: Treatment Acceptability and Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)
Validated questionnaire assessing how acceptable participants find an intervention as well as ease of adherence.
Measured: Three-week follow-up
Three-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)
Validated questionnaire assessing acceptability of and discomfort caused by an intervention.
Measured: Three-week follow-up
Secondary outcomes (2)
Change in self-reported reassurance-seeking
Pre-post assessment of change in the number of times per day that participants self-report reassurance seeking behaviour from the baseline monitoring week to the follow-up assessments.
Measured: Baseline to one-week follow-up and baseline to three-week follow-up
Change in anxiety
Pre-post assessment of change in participants' self-reported anxiety ratings, as rated from 0-100
Measured: Baseline (monitoring week 1) to end of reassurance provision week (monitoring week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionNov 2017
Why it stopped: Recruitment difficulties / lack of participants
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Neal, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909660
- Sponsor's protocol ID
- 30006114
- Status last verified
- Dec 2017
- First submitted
- 14 Sep 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT02909660
- Acronym / sponsor ID
- 30006114
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties / lack of participants
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 Sep 2016 (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 evaluates the efficacy and acceptability of two cognitive-behavioural interventions for reassurance seeking behaviour in obsessive-compulsive disorder (OCD), a family accommodation reduction protocol vs. a novel support-seeking protocol. Half of participants will be randomly assigned to participate in the support-seeking intervention, whereas the other half will participate in the family accommodation reduction intervention.
Detailed description
An existing family accommodation reduction intervention to reduce reassurance seeking behaviour in OCD (which represents treatment as usual, or TAU) is being compared to a novel support-seeking intervention to determine which is more efficacious and acceptable to participants.
The TAU protocol asks participants to make an agreement with their significant others to withhold reassurance when it is sought. It is believed that this behaviourally-based intervention encourages extinction of reassurance seeking over time by eliminating reinforcement of the behaviour by significant others.
The support-seeking intervention asks participants to move towards adaptively seeking support from a significant other to manage anxiety or distress rather than seeking reassurance. Significant others are taught to provide support rather than reassurance. It is believed that support-seeking may reduce reassurance seeking behaviour because it helps participants manage the anxiety or distress that underlies the requests for reassurance without interfering with disconfirmatory learning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Support-seeking intervention | Experimental | Other: Cognitive-behavioural therapyCognitive-behavioural therapy intervention that guides participants to seek support rather than reassurance; participants' significant others are asked to provide support rather than reassurance. |
| Family accommodation reduction intervention | Active comparator | Other: Cognitive-behavioural therapyCognitive-behavioural therapy intervention that guides participants' significant others to withhold reassurance when it is requested; participants are asked to refrain from seeking reassurance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of OCD
- Engaging in reassurance seeking more than once a day about the same thing
- Willingness to allow the experimenter to contact a significant other from whom the participant seeks reassurance regularly
- Ability to read, write, and communicate in English
Key exclusion criteria (5 listed)
- Current suicidal ideation/intent
- Current substance abuse
- Psychosis
- Diagnosis of bipolar disorder (I or II)
- If participants are on medication they must be on a stable dose (i.e., have maintained a consistent dose for at least three months) and agree not to change their medication regimen for the duration of the study
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 |
|---|---|---|
| Cognitive-behavioural therapyEmpirically-supported psychological intervention for various mental health concerns including obsessive-compulsive disorder (OCD). Includes components to foster cognitive (i.e., thinking) and behavioural changes. | Other | Family accommodation reduction intervention, Support-seeking intervention |
Primary outcome
Self-reported reassurance seeking behaviour
Time frame: 5 weeks (baseline through 3 week follow-up)
Number of times participants self-report seeking reassurance per day
Self-reported support-seeking behaviour
Time frame: 4 weeks (condition assignment through 3 week follow-up)
Number of times participants in the support-seeking condition self-report seeking reassurance per day
Self-reported anxiety
Time frame: 5 weeks (baseline monitoring through 3 week follow-up)
Level of anxiety on average per day, self-rated from 0-100
One-week follow-up: Treatment Acceptability and Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)
Time frame: One-week follow-up
Validated questionnaire assessing how acceptable participants find an intervention as well as ease of adherence.
One-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)
Time frame: One-week follow-up
Validated questionnaire assessing acceptability of and discomfort caused by an intervention.
Three-week follow-up: Treatment Acceptability and Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)
Time frame: Three-week follow-up
Validated questionnaire assessing how acceptable participants find an intervention as well as ease of adherence.
Three-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)
Time frame: Three-week follow-up
Validated questionnaire assessing acceptability of and discomfort caused by an intervention.
2 secondary outcomes
Change in self-reported reassurance-seeking
Time frame: Baseline to one-week follow-up and baseline to three-week follow-up
Change in anxiety
Time frame: Baseline (monitoring week 1) to end of reassurance provision week (monitoring week 2)
Results and safety
The study was stopped early (reason given: Recruitment difficulties / lack of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- 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 Cognitive-behavioural therapy in people with Obsessive-Compulsive Disorder, run by Concordia University, Montreal 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 5 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: stopped early, as of the sponsor's last update on 12 Dec 2017. 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 stopped early (reason given: Recruitment difficulties / lack of participants). Results are not available in the source record.
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?
Self-reported reassurance seeking behaviour (time frame: 5 weeks (baseline through 3 week follow-up)). The study lists 7 primary outcomes in all. 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 12 Dec 2017.