NCT01947179

Brief Summary

The purpose of this study is to test the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress Disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable anxiety

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

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

1.3 years

First QC Date

September 12, 2013

Last Update Submit

September 25, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety Sensitivity Index (ASI)

    The ASI is a 16-item self-report measure of anxiety sensitivity. Each item consists of a possible negative consequence of anxiety symptoms. The scale assesses three AS subfactors including cognitive, physical, and social concerns. The measure has shown good psychometric properties.

    Month one follow-up

Secondary Outcomes (1)

  • Beck Suicide Scale (BSS)

    Month one follow-up

Other Outcomes (1)

  • Posttraumatic Diagnostic Scale (PDS)

    Month one follow-up

Study Arms (2)

Physical Health Training

NO INTERVENTION

The Physical Health Training condition will include information on the importance and benefits of a healthy lifestyle. Additionally, the program will discuss guidelines for a healthy lifestyle including information on diet, water consumption, exercise, and sleep.

Anxiety Risk Reduction

EXPERIMENTAL

The anxiety risk reduction intervention will include psychoeducation focused on the nature of stress and its effect on the body. Interoceptive exposure exercises that were designed to correct the conditioned fear of bodily sensations will be explained and practiced.

Behavioral: Anxiety Risk Reduction

Interventions

Involves psychoeducation and interoceptive exposure exercises

Anxiety Risk Reduction

Eligibility Criteria

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

You may qualify if:

  • At or above the community sample mean on the ASI
  • English speakers
  • years of age or older

You may not qualify if:

  • Significant medical illness
  • Current substance dependence
  • Current or past psychotic-spectrum disorders
  • Uncontrolled bipolar disorder
  • Serious suicidal intent that warranted immediate medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, 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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 20, 2013

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations