Clinical trial NCT03416504: Methods for Managing Intrusive Thoughts
Official title: A Translational Study of the Mechanisms of Exposure Therapy for Obsessions: Gradual vs. Variable Exposure Intensity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Association for Behavioral and Cognitive Therapies (ABCT)
name: American Psychological Association (APA)
First posted: 2018-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to either gradual or variable exposure
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at 3-month follow-up (week 14)
timeFrame: Baseline (week 0) and 3-month follow-up (week 14)
Secondary outcomes:
measure: Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at post-treatment (week 2)
timeFrame: Baseline (week 0) and post-treatment (week 2)
measure: Changes from baseline in Dimensional Obsessive-Compulsive Scale-Unacceptable Thoughts (DOCS-UT) at 3-month follow-up (week 14)
timeFrame: Baseline (week 0) and 3-month follow-up (week 14)
measure: Changes from baseline in Dimensional Obsessive-Compulsive Scale-Unacceptable Thoughts (DOCS-UT) at post-treatment (week 2)
timeFrame: Baseline (week 0) and post-treatment (week 2)
measure: Changes from baseline in Behavioral Approach Test (BAT) Mean Subjective Units of Distress (SUDS) at 3-month follow-up (week 14)
timeFrame: Baseline (week 0) and 3-month follow-up (week 14)
measure: Changes from baseline in Behavioral Approach Test (BAT) Mean Subjective Units of Distress (SUDS) at post-treatment (week 2)
timeFrame: Baseline (week 0) and post-treatment (week 2)
measure: Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at 3-month follow-up (week 14)
timeFrame: Baseline (week 0) and 3-month follow-up (week 14)
measure: Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at post-treatment (week 2)
timeFrame: Baseline (week 0) and post-treatment (week 2)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jonathan S Abramowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacoby RJ, Abramowitz JS, Blakey SM, Reuman L. Is the hierarchy necessary? Gradual versus variable exposure intensity in the treatment of unacceptable obsessional thoughts. J Behav Ther Exp Psychiatry. 2019 Sep;64:54-63. doi: 10.1016/j.jbtep.2019.02.008. Epub 2019 Feb 26.