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

December 10, 2017 updated by: Rachael Neal, Concordia University, Montreal
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.

Study Overview

Status

Terminated

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

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H4B 1R6
        • Concordia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 10, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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