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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive-behavioural therapy
Sponsored by
Concordia University, Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Concordia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Support-seeking intervention

Family accommodation reduction intervention

Arm Description

Cognitive-behavioural therapy intervention that guides participants to seek support rather than reassurance; participants' significant others are asked to provide support rather than reassurance.

Cognitive-behavioural therapy intervention that guides participants' significant others to withhold reassurance when it is requested; participants are asked to refrain from seeking reassurance.

Outcomes

Primary Outcome Measures

Self-reported reassurance seeking behaviour
Number of times participants self-report seeking reassurance per day
Self-reported support-seeking behaviour
Number of times participants in the support-seeking condition self-report seeking reassurance per day
Self-reported anxiety
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)
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)
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)
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)
Validated questionnaire assessing acceptability of and discomfort caused by an intervention.

Secondary Outcome Measures

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.
Change in anxiety
Pre-post assessment of change in participants' self-reported anxiety ratings, as rated from 0-100

Full Information

First Posted
September 14, 2016
Last Updated
December 10, 2017
Sponsor
Concordia University, Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT02909660
Brief Title
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
Official Title
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties / lack of participants
Study Start Date
September 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Concordia University, Montreal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Support-seeking intervention
Arm Type
Experimental
Arm Description
Cognitive-behavioural therapy intervention that guides participants to seek support rather than reassurance; participants' significant others are asked to provide support rather than reassurance.
Arm Title
Family accommodation reduction intervention
Arm Type
Active Comparator
Arm Description
Cognitive-behavioural therapy intervention that guides participants' significant others to withhold reassurance when it is requested; participants are asked to refrain from seeking reassurance.
Intervention Type
Other
Intervention Name(s)
Cognitive-behavioural therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported reassurance seeking behaviour
Description
Number of times participants self-report seeking reassurance per day
Time Frame
5 weeks (baseline through 3 week follow-up)
Title
Self-reported support-seeking behaviour
Description
Number of times participants in the support-seeking condition self-report seeking reassurance per day
Time Frame
4 weeks (condition assignment through 3 week follow-up)
Title
Self-reported anxiety
Description
Level of anxiety on average per day, self-rated from 0-100
Time Frame
5 weeks (baseline monitoring through 3 week follow-up)
Title
One-week follow-up: Treatment Acceptability and Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)
Description
Validated questionnaire assessing how acceptable participants find an intervention as well as ease of adherence.
Time Frame
One-week follow-up
Title
One-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)
Description
Validated questionnaire assessing acceptability of and discomfort caused by an intervention.
Time Frame
One-week follow-up
Title
Three-week follow-up: Treatment Acceptability and Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)
Description
Validated questionnaire assessing how acceptable participants find an intervention as well as ease of adherence.
Time Frame
Three-week follow-up
Title
Three-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)
Description
Validated questionnaire assessing acceptability of and discomfort caused by an intervention.
Time Frame
Three-week follow-up
Secondary Outcome Measure Information:
Title
Change in self-reported reassurance-seeking
Description
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.
Time Frame
Baseline to one-week follow-up and baseline to three-week follow-up
Title
Change in anxiety
Description
Pre-post assessment of change in participants' self-reported anxiety ratings, as rated from 0-100
Time Frame
Baseline (monitoring week 1) to end of reassurance provision week (monitoring week 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Concordia University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4B 1R6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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