NCT02874417

Brief Summary

This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the development and maintenance of various forms of psychopathology.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

August 8, 2016

Last Update Submit

August 16, 2016

Conditions

Anxiety Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Anxiety Sensitivity Index-3

    Measure of anxiety sensitivity

    10 minutes post intervention

Study Arms (2)

Psychoeducation

EXPERIMENTAL

The program was designed to dispel exaggerated thoughts surrounding the danger of the experience of anxiety symptoms, specifically focusing on fears regarding feelings of cognitive dyscontrol. The psychoeducation portion contains video animation and audio narration throughout, as well as some interactive features . Participants are provided with corrective information about the experience of anxiety-related sensations, with a particular focus on dispelling myths commonly held by individuals with high anxiety sensitivity cognitive concerns . Participants are taught that anxiety-related sensations are not dangerous and that they may have developed a conditioned fear to these symptoms of arousal.

Behavioral: CAST psychoeducation

Health and Wellness

PLACEBO COMPARATOR

The controlled condition consisted Physical Health Education Training (PHET), a computerized presentation which focuses on information on general healthy living. The PHET program contains information on nutrition, alcohol, water consumption, exercise, sexual health, hygiene, stress management, life organization, social support, positive outlook, and sleep.

Behavioral: PHET

Interventions

CAST psychoeducationBEHAVIORAL
Psychoeducation
PHETBEHAVIORAL
Health and Wellness

Eligibility Criteria

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

You may qualify if:

  • Elevated Anxiety Sensitivity Cognitive Concerns and indicated by the anxiety sensitivity index-3

You may not qualify if:

  • History of epilepsy or seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

August 8, 2016

First Posted

August 22, 2016

Study Start

September 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 22, 2016

Record last verified: 2016-08