- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02909660
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4B 1R6
- Concordia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Support-seeking intervention
Cognitive-behavioural therapy intervention that guides participants to seek support rather than reassurance; participants' significant others are asked to provide support rather than reassurance.
|
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.
|
|
Active Comparator: Family accommodation reduction intervention
Cognitive-behavioural therapy intervention that guides participants' significant others to withhold reassurance when it is requested; participants are asked to refrain from seeking reassurance.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5 weeks (baseline through 3 week follow-up)
|
|
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
|
4 weeks (condition assignment through 3 week follow-up)
|
|
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
|
5 weeks (baseline monitoring through 3 week follow-up)
|
|
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
|
|
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.
|
One-week follow-up
|
|
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
|
|
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.
|
Three-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-reported reassurance-seeking
Time Frame: Baseline to one-week follow-up and baseline to three-week follow-up
|
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.
|
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)
|
Pre-post assessment of change in participants' self-reported anxiety ratings, as rated from 0-100
|
Baseline (monitoring week 1) to end of reassurance provision week (monitoring week 2)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30006114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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