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Methods for Managing Intrusive Thoughts

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ClinicalTrials.gov Identifier: NCT03416504
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Association for Behavioral and Cognitive Therapies (ABCT)
American Psychological Association (APA)
Information provided by (Responsible Party):
Jon Abramowitz, PhD, 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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Gradual Exposure (EXP-G) Behavioral: Variable Exposure (EXP-V) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomly assigned to either gradual or variable exposure
Masking: Single (Outcomes Assessor)
Masking Description: Independent evaluators were blind to the exposure condition participants were assigned to.
Primary Purpose: Treatment
Official Title: A Translational Study of the Mechanisms of Exposure Therapy for Obsessions: Gradual vs. Variable Exposure Intensity
Actual Study Start Date : September 22, 2015
Actual Primary Completion Date : October 4, 2016
Actual Study Completion Date : October 4, 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416504


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Association for Behavioral and Cognitive Therapies (ABCT)
American Psychological Association (APA)
Investigators
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Principal Investigator: Jonathan S Abramowitz, PhD University of North Carolina, Chapel Hill
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jon Abramowitz, PhD, Professor, Clinical Psychology, Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03416504    
Other Study ID Numbers: 14-3310
5101599 ( Other Identifier: ABCT )
5103050 ( Other Identifier: APA )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jon Abramowitz, PhD, University of North Carolina, Chapel Hill:
OCD
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders