Mobile Interpretation Bias Modification Clinical Trial

NCT04129866 | Unknown

• 1 other identifier: W81XWH-16-2-0004
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Sensitivity; Suicidal Ideation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

M-IBM

EXPERIMENTAL

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

Control IBM

PLACEBO COMPARATOR

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

Interventions

M-IBM BEHAVIORAL

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".

M-IBM

Control-IBM BEHAVIORAL

Placebo IBM where sentences are not related to anxious threat meaning of cue word.

Control IBM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern Mississippi: lead
• Military Suicide Research Consortium: collaborator

Study Sites (1)

University of Southern Mississippi

Hattiesburg, Mississippi, 39406-0002, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 17, 2019
• Study Start: December 15, 2019
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)