- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02874417
Computerized Psychoeducation for Anxiety Sensitivity
August 16, 2016 updated by: Norman Schmidt, Florida State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Elevated Anxiety Sensitivity Cognitive Concerns and indicated by the anxiety sensitivity index-3
Exclusion Criteria:
- History of epilepsy or seizures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychoeducation
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.
|
|
|
Placebo Comparator: Health and Wellness
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Sensitivity Index-3
Time Frame: 10 minutes post intervention
|
Measure of anxiety sensitivity
|
10 minutes post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
August 8, 2016
First Submitted That Met QC Criteria
August 16, 2016
First Posted (Estimate)
August 22, 2016
Study Record Updates
Last Update Posted (Estimate)
August 22, 2016
Last Update Submitted That Met QC Criteria
August 16, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Norr01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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