Methods for Managing Intrusive Thoughts

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: Gradual Exposure (EXP-G); Behavioral: Variable Exposure (EXP-V)

• Registration Number: NCT03416504
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Timeline

• Study Start: 2015-09-22
• Primary Completion: 2016-10-04
• Study Completion: 2016-10-04
• Status Verified: 2018-01
• Study First Submitted: 2018-01-21
• Study First Submitted QC: 2018-01-29
• Last Update Submitted: 2018-01-29
• Study First Posted: 2018-01-31
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gradual Exposure Group	Gradual Exposure (EXP-G)	The gradual exposure group received the Gradual Exposure (EXP-G) Intervention.
Variable Exposure Group	Variable Exposure (EXP-V)	The variable exposure group received the Variable Exposure (EXP-V) Intervention.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at 3-month follow-up (week 14)	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 Outcome Measures

Name	Time	Method
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)	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).
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)	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).
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)	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).
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)	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).
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)	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).
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)	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).
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)	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).

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States