Methods for Managing Intrusive Thoughts

January 29, 2018 updated by: Jon Abramowitz, PhD, University of North Carolina, Chapel Hill

A Translational Study of the Mechanisms of Exposure Therapy for Obsessions: Gradual vs. Variable Exposure Intensity

The current study sought to translate laboratory research on learning and memory to better understand the mechanisms and methods for implementing exposure therapy for unwanted obsessional thoughts. Specifically, we compared the processes and the short- and long-term outcomes of: (a) gradual exposure (EXP-G), emphasizing hierarchical exposure completion, versus (b) variable exposure (EXP-V), emphasizing variability in exposure intensity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although preliminary research suggests that learning to tolerate varying levels of fear during exposure enhances outcomes for some anxiety-related problems, no previous study has examined this possibility in the context of unwanted obsessions. Adults with a moderately distressing obsessional thought were randomly assigned to four twice-weekly sessions of either: (a) gradual exposure (EXP-G), emphasizing hierarchical exposure completion, or (b) variable exposure (EXP-V), emphasizing variability in exposure intensity.

Study Type

Interventional

Enrollment (Actual)

40

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

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

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:

  • At least 18 years old
  • Willing to attend and audiotape all study sessions
  • Fluent in English
  • Presence of one or more obsessional thoughts that cause marked distress
  • If on a psychiatric medication (e.g., SSRI), willing to remain at a fixed dose while participating in the study (and stabilized on medication for 30 days before beginning the intervention).

Exclusion Criteria:

  • Previous cognitive behavioral therapy (CBT) for anxiety
  • Current suicidal ideation
  • Current substance use disorder
  • Current mania or psychosis
  • Currently taking an anxiolytic (e.g., Ativan) or stimulant (e.g., Ritalin) medication
  • Heart, respiratory, or neurological condition
  • Current pregnancy

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gradual Exposure Group
The gradual exposure group received the Gradual Exposure (EXP-G) Intervention.
Behavioral: Gradual Exposure (EXP-G)
In EXP-G, exposure proceeded hierarchically from mildly, to moderately, to highly intense stimuli so that exposure intensity gradually built between (but not within) sessions.
Experimental: Variable Exposure Group
The variable exposure group received the Variable Exposure (EXP-V) Intervention.
Behavioral: Variable Exposure (EXP-V)
In EXP-V, exposure stimuli were chosen at random (i.e., pieces of paper with exposure stimuli written on them were pulled randomly from an opaque container) so that mild, moderate, and high intensity exposures could occur in any order during any of the sessions (the participant was not informed which level was coming next). This aimed to maximize (a) uncertainty, (b) variability in exposure intensity, and (c) variability in corresponding physiological arousal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at 3-month follow-up (week 14)
Time Frame: Baseline (week 0) and 3-month follow-up (week 14)
The Y-BOCS is a clinician-administered interview that assesses obsessive compulsive disorder (OCD) symptom severity over the past week. This measure will be used to assess change over the course of the intervention at four time-points throughout the study (over approximately 3.5 months total).
Baseline (week 0) and 3-month follow-up (week 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at post-treatment (week 2)
Time Frame: Baseline (week 0) and post-treatment (week 2)
The Y-BOCS is a clinician-administered interview that assesses obsessive compulsive disorder (OCD) symptom severity over the past week. This measure will be used to assess change over the course of the intervention at four time-points throughout the study (over approximately 3.5 months total).
Baseline (week 0) and post-treatment (week 2)
Changes from baseline in Dimensional Obsessive-Compulsive Scale-Unacceptable Thoughts (DOCS-UT) at 3-month follow-up (week 14)
Time Frame: Baseline (week 0) and 3-month follow-up (week 14)
The DOCS-UT is a self-report measure of the clinical severity of the unwanted thoughts (UT) OCD symptom dimension. This measure will be used to assess change over the course of the intervention at four time-points throughout the study (over approximately 3.5 months total).
Baseline (week 0) and 3-month follow-up (week 14)
Changes from baseline in Dimensional Obsessive-Compulsive Scale-Unacceptable Thoughts (DOCS-UT) at post-treatment (week 2)
Time Frame: Baseline (week 0) and post-treatment (week 2)
The DOCS-UT is a self-report measure of the clinical severity of the unwanted thoughts (UT) OCD symptom dimension. This measure will be used to assess change over the course of the intervention at four time-points throughout the study (over approximately 3.5 months total).
Baseline (week 0) and post-treatment (week 2)
Changes from baseline in Behavioral Approach Test (BAT) Mean Subjective Units of Distress (SUDS) at 3-month follow-up (week 14)
Time Frame: Baseline (week 0) and 3-month follow-up (week 14)
The BAT is an in vivo measure of participants' behavioral responses to their target obsession. Participant SUDS were collected for 5 increasingly difficult steps participants completed related to their obsessional thought. This measure will be used to assess change over the course of the intervention at four time-points throughout the study (over approximately 3.5 months total).
Baseline (week 0) and 3-month follow-up (week 14)
Changes from baseline in Behavioral Approach Test (BAT) Mean Subjective Units of Distress (SUDS) at post-treatment (week 2)
Time Frame: Baseline (week 0) and post-treatment (week 2)
The BAT is an in vivo measure of participants' behavioral responses to their target obsession. Participant SUDS were collected for 5 increasingly difficult steps participants completed related to their obsessional thought. This measure will be used to assess change over the course of the intervention at four time-points throughout the study (over approximately 3.5 months total).
Baseline (week 0) and post-treatment (week 2)
Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at 3-month follow-up (week 14)
Time Frame: Baseline (week 0) and 3-month follow-up (week 14)
The BAT is an in vivo measure of participants' responses to their target obsession. The number of steps participants were able to complete without performing a ritual were calculated. This measure will be used to assess change over the course of the intervention at four time-points throughout the study (over approximately 3.5 months total).
Baseline (week 0) and 3-month follow-up (week 14)
Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at post-treatment (week 2)
Time Frame: Baseline (week 0) and post-treatment (week 2)
The BAT is an in vivo measure of participants' responses to their target obsession. The number of steps participants were able to complete without performing a ritual were calculated. This measure will be used to assess change over the course of the intervention at four time-points throughout the study (over approximately 3.5 months total).
Baseline (week 0) and post-treatment (week 2)

Collaborators and Investigators

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

Sponsor

University of North Carolina, Chapel Hill

Collaborators

American Psychological Association (APA)
Association for Behavioral and Cognitive Therapies (ABCT)

Investigators

  • Principal Investigator: Jonathan S Abramowitz, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 22, 2015

Primary Completion (Actual)

October 4, 2016

Study Completion (Actual)

October 4, 2016

Study Registration Dates

First Submitted

January 21, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-3310
  • 5101599 (Other Identifier: ABCT)
  • 5103050 (Other Identifier: APA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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