NCT01990131

Brief Summary

The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments 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 a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Oct 2013

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

November 15, 2013

Last Update Submit

August 8, 2016

Conditions

AnxietySuicide

Keywords

computerized interventioncognitive bias modificationanxietysuicide

Outcome Measures

Primary Outcomes (1)

  • Anxiety Sensitivity Index-3 (ASI-3)

    The ASI-3 is an 18-item self-report measure of anxiety sensitivity (AS). This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. Each subfactor is represented by six items. The measure has shown good psychometric properties.

    Month 4 follow-up

Secondary Outcomes (1)

  • Beck Suicide Scale (BSS)

    Month 4 follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced.

Other: Cognitive Anxiety Sensitivity Treatment

Control

PLACEBO COMPARATOR

The control condition will be a combination of information about general health and wellness (e.g. diet, exercise etc.) plus an inert Cognitive Bias Modification (CBM-I) task.

Other: Physical Health Education Training

Interventions

Cognitive Anxiety Sensitivity TreatmentOTHER
Also known as: Computerized Anxiety Treatment for Suicide (CATS)
Intervention
Physical Health Education TrainingOTHER
Control

Eligibility Criteria

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

You may qualify if:

  • Meet diagnostic criteria for a primary Axis 1 anxiety disorder or meet diagnostic criteria for a unipolar mood disorder along with an Axis 1 anxiety disorder.
  • Show evidence of current suicidal ideation (BSS above 6.
  • Show elevated AS indicated by scoring at or above the community sample mean on the ASI-Cog (above 9.

You may not qualify if:

  • No significant medical illness (e.g. sig cardiovascular disease, epilepsy, stroke).
  • Current or past psychotic-spectrum disorders or uncontrolled bipolar disorder
  • No current substance dependence
  • Must be an English speaker.
  • Must be 18 years or older.
  • Must have normal or corrected vision
  • Cannot begin treatment/therapy within 1 month of baseline.
  • Cannot begin a new medication within 3 months of baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anxiety and Behavioral Health Clinic

Tallahassee, Florida, 32304, United States

Location

Related Publications (1)

  • Schmidt NB, Norr AM, Allan NP, Raines AM, Capron DW. A randomized clinical trial targeting anxiety sensitivity for patients with suicidal ideation. J Consult Clin Psychol. 2017 Jun;85(6):596-610. doi: 10.1037/ccp0000195. Epub 2017 Mar 13.

    PMID: 28287798DERIVED

MeSH Terms

Conditions

Anxiety DisordersSuicide

Condition Hierarchy (Ancestors)

Mental DisordersSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

US(1)