Back to resultsMethods for Managing Intrusive Thoughts
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gradual Exposure (EXP-G)
Variable Exposure (EXP-V)
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD
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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gradual Exposure Group
Variable Exposure Group
Arm Description
The gradual exposure group received the Gradual Exposure (EXP-G) Intervention.
The variable exposure group received the Variable Exposure (EXP-V) Intervention.
Outcomes
Primary Outcome Measures
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at 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
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at 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 Dimensional Obsessive-Compulsive Scale-Unacceptable Thoughts (DOCS-UT) at 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)
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 Behavioral Approach Test (BAT) Mean Subjective Units of Distress (SUDS) at 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) Mean Subjective Units of Distress (SUDS) at 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 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).
Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at 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).
Full Information
NCT ID
NCT03416504
First Posted
January 21, 2018
Last Updated
January 29, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Association for Behavioral and Cognitive Therapies (ABCT), American Psychological Association (APA)
1. Study Identification
Unique Protocol Identification Number
NCT03416504
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 22, 2015 (Actual)
Primary Completion Date
October 4, 2016 (Actual)
Study Completion Date
October 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Association for Behavioral and Cognitive Therapies (ABCT), American Psychological Association (APA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
OCD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned to either gradual or variable exposure
Masking
Outcomes Assessor
Masking Description
Independent evaluators were blind to the exposure condition participants were assigned to.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gradual Exposure Group
Arm Type
Experimental
Arm Description
The gradual exposure group received the Gradual Exposure (EXP-G) Intervention.
Arm Title
Variable Exposure Group
Arm Type
Experimental
Arm Description
The variable exposure group received the Variable Exposure (EXP-V) Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Gradual Exposure (EXP-G)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Variable Exposure (EXP-V)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at 3-month follow-up (week 14)
Description
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).
Time Frame
Baseline (week 0) and 3-month follow-up (week 14)
Secondary Outcome Measure Information:
Title
Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score at post-treatment (week 2)
Description
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).
Time Frame
Baseline (week 0) and post-treatment (week 2)
Title
Changes from baseline in Dimensional Obsessive-Compulsive Scale-Unacceptable Thoughts (DOCS-UT) at 3-month follow-up (week 14)
Description
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).
Time Frame
Baseline (week 0) and 3-month follow-up (week 14)
Title
Changes from baseline in Dimensional Obsessive-Compulsive Scale-Unacceptable Thoughts (DOCS-UT) at post-treatment (week 2)
Description
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).
Time Frame
Baseline (week 0) and post-treatment (week 2)
Title
Changes from baseline in Behavioral Approach Test (BAT) Mean Subjective Units of Distress (SUDS) at 3-month follow-up (week 14)
Description
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).
Time Frame
Baseline (week 0) and 3-month follow-up (week 14)
Title
Changes from baseline in Behavioral Approach Test (BAT) Mean Subjective Units of Distress (SUDS) at post-treatment (week 2)
Description
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).
Time Frame
Baseline (week 0) and post-treatment (week 2)
Title
Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at 3-month follow-up (week 14)
Description
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).
Time Frame
Baseline (week 0) and 3-month follow-up (week 14)
Title
Changes from baseline in Behavioral Approach Test (BAT) Number of Steps Completed at post-treatment (week 2)
Description
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).
Time Frame
Baseline (week 0) and post-treatment (week 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S Abramowitz, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30851653
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.
Results Reference
derived
Learn more about this trial
Methods for Managing Intrusive Thoughts
We'll reach out to this number within 24 hrs