Mobile Interpretation Bias Modification Clinical Trial

Not Applicable

• Conditions: Anxiety Sensitivity; Suicidal Ideation
• Interventions: Behavioral: Control-IBM; Behavioral: M-IBM

• Registration Number: NCT04129866
• Lead Sponsor: University of Southern Mississippi

Brief Summary

The Mobile-Interpretation Bias Modification clinical trial aims to examine the efficacy of a brief mobile phone delivered interpretation bias modification to reduce anxiety sensitivity cognitive concerns and suicidal ideation in National Guard Personnel. The investigators propose a randomized controlled trial testing the efficacy, acceptability, and usability of M-IBM with a sample of 114 National Guardsmen with current suicidal ideation and elevated anxiety sensitivity cognitive concerns. Participants will complete assessments, receive assistance on installing M- IBM on their phone, complete an M-IBM intervention session, and complete post-intervention assessments. Baseline measures of psychopathology, and usability/acceptability of M-IBM will be obtained during the initial session. In addition, 1-month, and 3-month follow-ups would be scheduled to examine changes in psychopathology. The investigators hypothesize that those randomized to M-IBM will experience reductions in anxiety sensitivity cognitive concerns, suicidal ideation. In addition participants will find M-IBM acceptable and easy to use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Study Start: 2019-12-15
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Elevated ASCC (>2) and include only Guard members who also have current SI (> 0) .
• Ownership of a smartphone

Exclusion Criteria

• those determined by military or study personnel to be actively psychotic, manic, or imminently suicidal and in need of emergency services

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control IBM	Control-IBM	Control-IBM is identical to M-IBM except that the sentence that follows the cue word is not related to an anxious-threat interpretation of the cue word.
M-IBM	M-IBM	M-IBM is based on a slightly modified version of the word sentence association paradigm focused on words and sentences related to common concerns among those with elevated anxiety sensitivity cognitive concerns (i.e., losing control of mental processes).

Primary Outcome Measures

Name	Time	Method
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale	3 months post intervention	Range 0 - 24, Higher Scores mean more pathology
The Self-Injurious Thoughts and Behaviors Interview	3 months post intervention

Trial Locations

Locations (1)

University of Southern Mississippi; 🇺🇸 Hattiesburg, Mississippi, United States