Mobile Interpretation Bias Modification Clinical Trial (M-IBM)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Suicidal Ideation; Anxiety Sensitivity
• Intervention / Treatment: Behavioral: M-IBM; Behavioral: Control-IBM

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39406-0002
      • University of Southern Mississippi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Behavioral: M-IBM; In this paradigm, an ambiguous word or two-word phrase related to ASCC is followed by a sentence that resolves the word-sentence meaning as threatening or benign. For example, participants are presented with an ambiguous word or two-word phrase for 1 second. On half the trials the combination of the word/phrase and sentence creates a benign meaning (as in the previous example). On the other half of trials this combination creates an anxious-threat meaning Participants are required to judge the relatedness of the word/phrase and the sentence. Participants are given feedback during training such that judging the anxious-threat combinations to be "unrelated" and the benign combinations as being "related" would produce a "correct" response. In contrast, if participants produce an "incorrect" response they see "incorrect".
PLACEBO_COMPARATOR: 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.	Behavioral: Control-IBM; Placebo IBM where sentences are not related to anxious threat meaning of cue word.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale	Range 0 - 24, Higher Scores mean more pathology	30 minutes
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale	Range 0 - 24, Higher Scores mean more pathology	1 month post intervention
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale	Range 0 - 24, Higher Scores mean more pathology	3 months post intervention
The Self-Injurious Thoughts and Behaviors Interview		1 month post intervention
The Self-Injurious Thoughts and Behaviors Interview		3 months post intervention

Collaborators and Investigators

• Sponsor: University of Southern Mississippi
• Collaborators: Military Suicide Research Consortium

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2019
• Primary Completion (ANTICIPATED): March 29, 2023
• Study Completion (ANTICIPATED): March 29, 2023

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (ACTUAL): October 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: W81XWH-16-2-0004 (Other Grant/Funding Number: Military Suicide Research Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No