What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02909660
• Other study ID #: 30006114
• Status: Terminated
• Phase: N/A
• First received: September 14, 2016
• Last updated: December 10, 2017
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2017
• Source: Concordia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder

Intervention

Other:
• Cognitive-behavioural therapy
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.

Locations

Country	Name	City	State
Canada	Concordia University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Concordia University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported reassurance seeking behaviour	Number of times participants self-report seeking reassurance per day	5 weeks (baseline through 3 week follow-up)
Primary	Self-reported support-seeking behaviour	Number of times participants in the support-seeking condition self-report seeking reassurance per day	4 weeks (condition assignment through 3 week follow-up)
Primary	Self-reported anxiety	Level of anxiety on average per day, self-rated from 0-100	5 weeks (baseline monitoring through 3 week follow-up)
Primary	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.	One-week follow-up
Primary	One-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)	Validated questionnaire assessing acceptability of and discomfort caused by an intervention.	One-week follow-up
Primary	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.	Three-week follow-up
Primary	Three-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)	Validated questionnaire assessing acceptability of and discomfort caused by an intervention.	Three-week follow-up
Secondary	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.	Baseline to one-week follow-up and baseline to three-week follow-up
Secondary	Change in anxiety	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)