NCT02818296

Brief Summary

This investigation examines the efficacy of a brief, one-session computerized interpretation bias modification paradigm (CBM-I) in the reduction of intolerance of uncertainty. Intolerance of uncertainty is a risk factor for the development and maintenance of various forms of psychopathology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

June 21, 2016

Last Update Submit

June 27, 2016

Conditions

Intolerance of Uncertainty; Anxiety

Keywords

Intolerance of uncertaintyAnxiety

Outcome Measures

Primary Outcomes (1)

  • Change in Intolerance of Uncertainty Scale-Short Form

    Post-Intervention (directly following the intervention during their baseline appointment) to Month 1 Follow-up

Study Arms (2)

Active IU CBM-I

EXPERIMENTAL

This paradigm was designed to train individuals to endorse benign interpretations of ambiguous information and reject negative/threatening interpretations of ambiguous information. Participant's baseline interpretation bias was measured at baseline. Participants then underwent two training phases in which their responses were either reinforced (i.e., they were told they were correct) or punished (i.e., they were told that they were incorrect). Interpretation bias was measured again at post-training.

Behavioral: Active IU CBM-I

Control CBM-I

SHAM COMPARATOR

This paradigm was identical to the active condition except that the word/sentence pairings used were not relevant to IU and/or anxiety.

Behavioral: Control CBM-I

Interventions

Active IU CBM-IBEHAVIORAL
Active IU CBM-I
Control CBM-IBEHAVIORAL
Control CBM-I

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elevated IU interpretation bias at pre-intervention.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Research Professor

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 29, 2016

Study Start

August 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations

US(1)