Mobile Interpretation Bias Modification Clinical Trial

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2020

Interventions

  • 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”.
  • Behavioral: Control-IBM
    • Placebo IBM where sentences are not related to anxious threat meaning of cue word.

Arms, Groups and Cohorts

  • 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).
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Southern Mississippi
  • Collaborator
    • Military Suicide Research Consortium
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.