NCT02909660

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

September 14, 2016

Last Update Submit

December 10, 2017

Conditions

Outcome Measures

Primary Outcomes (7)

  • Self-reported reassurance seeking behaviour

    Number of times participants self-report seeking reassurance per day

    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

    4 weeks (condition assignment through 3 week follow-up)

  • Self-reported anxiety

    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)

    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)

    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)

    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)

    Validated questionnaire assessing acceptability of and discomfort caused by an intervention.

    Three-week follow-up

Secondary Outcomes (2)

  • Change in self-reported reassurance-seeking

    Baseline to one-week follow-up and baseline to three-week follow-up

  • Change in anxiety

    Baseline (monitoring week 1) to end of reassurance provision week (monitoring week 2)

Study Arms (2)

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.

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.

Other: Cognitive-behavioural therapy

Interventions

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.

Family accommodation reduction interventionSupport-seeking intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia University

Montreal, Quebec, H4B 1R6, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral student

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 21, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

December 12, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations