Methods for Managing Intrusive Thoughts

NCT03416504 | Completed

• 3 other identifiers: 14-331051015995103050
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (week 0) and 3-month follow-up (week 14)

Secondary Outcomes (7)

• 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 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)

• 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) Mean Subjective Units of Distress (SUDS) at post-treatment (week 2)

  Baseline (week 0) and post-treatment (week 2)

Study Arms (2)

Gradual Exposure Group

EXPERIMENTAL

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

Behavioral: Gradual Exposure (EXP-G)

Variable Exposure Group

EXPERIMENTAL

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

Behavioral: Variable Exposure (EXP-V)

Interventions

Gradual Exposure (EXP-G) BEHAVIORAL

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.

Gradual Exposure Group

Variable Exposure (EXP-V) BEHAVIORAL

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.

Variable Exposure Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Association for Behavioral and Cognitive Therapies (ABCT): collaborator
• American Psychological Association (APA): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 30851653 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Jonathan S Abramowitz, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators were blind to the exposure condition participants were assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Clinical Psychology, Department of Psychology and Neuroscience

Model Details: Participants were randomly assigned to either gradual or variable exposure

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 31, 2018
• Study Start: September 22, 2015
• Primary Completion: October 4, 2016
• Study Completion: October 4, 2016
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)