NCT04199884

Brief Summary

Randomized control trial examining the efficacy of an online intolerance of uncertainty focused psychoeducation intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

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

July 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

December 12, 2019

Last Update Submit

December 13, 2019

Conditions

Intolerance of UncertaintyAnxiety

Keywords

Intolerance of UncertaintyAnxiety

Outcome Measures

Primary Outcomes (2)

  • Intolerance of Uncertainty (IIU)

    Change IU across time

    Baseline to one-month follow-up

  • Beck Anxiety Inventory

    Change in beck anxiety inventory scores across time

    Baseline to one-month follow-up

Study Arms (2)

Active IU-focused Psychoeducation Intervention

EXPERIMENTAL
Behavioral: Active IU-focused Psychoeducation Intervention

Health-focused Psychoeducation Intervention

ACTIVE COMPARATOR
Behavioral: Health-focused Psychoeducation Intervention

Interventions

Active IU-focused Psychoeducation InterventionBEHAVIORAL

This paradigm was an IU-focused psychoeducation intervention wherein participants were provided psychoeducation about the nature of IU and anxiety, given strategies to cope with fear of uncertainty, and provided examples and information as to how they can expose themselves to uncertainty.

Active IU-focused Psychoeducation Intervention
Health-focused Psychoeducation InterventionBEHAVIORAL

This intervention is a health-focused psychoeducation intervention wherein participants learn ways to engage in healthy behaviors, such as getting adequate sleep, eating healthier, and exercising regularly.

Health-focused Psychoeducation Intervention

Eligibility Criteria

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

You may qualify if:

  • Elevated intolerance of uncertainty at baseline

You may not qualify if:

  • Patients would be excluded if they endorsed suicidal ideation/intent that required hospitalization.

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Research Professor

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 16, 2019

Study Start

July 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

December 16, 2019

Record last verified: 2019-12

Locations

US(1)