Mobile Interpretation Bias Modification Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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Mobile Interpretation Bias Modification Clinical Trial

Conditions
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Anxiety Sensitivity, Suicidal Ideation

Intervention / Treatment
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* Behavioral: M-IBM
* Behavioral: Control-IBM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M-IBM<br>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<br>* 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.<br>|
| Placebo Comparator: Control IBM<br>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<br>* Placebo IBM where sentences are not related to anxious threat meaning of cue word.<br>|

What is the study measuring?
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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 |