Methods for Managing Intrusive Thoughts

NCT ID: NCT03416504

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-22

Study Completion Date

2016-10-04

Brief Summary

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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

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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.

Conditions

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Obsessive-Compulsive Disorder

Keywords

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OCD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned to either gradual or variable exposure
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Independent evaluators were blind to the exposure condition participants were assigned to.

Study Groups

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Gradual Exposure Group

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

Group Type EXPERIMENTAL

Gradual Exposure (EXP-G)

Intervention Type 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.

Variable Exposure Group

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

Group Type EXPERIMENTAL

Variable Exposure (EXP-V)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association for Behavioral and Cognitive Therapies (ABCT)

UNKNOWN

Sponsor Role collaborator

American Psychological Association (APA)

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Jon Abramowitz, PhD

Professor, Clinical Psychology, Department of Psychology and Neuroscience

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan S Abramowitz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30851653 (View on PubMed)

Other Identifiers

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5101599

Identifier Type: OTHER

Identifier Source: secondary_id

5103050

Identifier Type: OTHER

Identifier Source: secondary_id

14-3310

Identifier Type: -

Identifier Source: org_study_id