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Clinical Trials/NCT03416504
NCT03416504CompletedNot Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country40 target enrollmentStarted: September 22, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at 3-month follow-up (week 14)

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Independent evaluators were blind to the exposure condition participants were assigned to.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Gradual Exposure Group

Experimental

The gradual exposure group received the Gradual Exposure (EXP-G) Intervention.

Intervention: Gradual Exposure (EXP-G) (Behavioral)

Variable Exposure Group

Experimental

The variable exposure group received the Variable Exposure (EXP-V) Intervention.

Intervention: Variable Exposure (EXP-V) (Behavioral)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Changes from baseline in Dimensional Obsessive-Compulsive Scale-Unacceptable Thoughts (DOCS-UT) at 3-month follow-up (week 14)(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)(Baseline (week 0) and post-treatment (week 2))
  • Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at post-treatment (week 2)(Baseline (week 0) and post-treatment (week 2))
  • Changes from baseline in Behavioral Approach Test (BAT) Mean Subjective Units of Distress (SUDS) at post-treatment (week 2)(Baseline (week 0) and post-treatment (week 2))
  • Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at post-treatment (week 2)(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)(Baseline (week 0) and 3-month follow-up (week 14))
  • Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at 3-month follow-up (week 14)(Baseline (week 0) and 3-month follow-up (week 14))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jon Abramowitz, PhD

Professor, Clinical Psychology, Department of Psychology and Neuroscience

University of North Carolina, Chapel Hill

Study Sites (1)

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