Mobile Interpretation Bias Modification Clinical Trial

Suicidal Ideation Clinical Trial

— M-IBM  

Official title:

Mobile Interpretation Bias Modification Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04129866
• Other study ID #: W81XWH-16-2-0004
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: March 29, 2023

Study information

• Verified date: May 2022
• Source: University of Southern Mississippi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 114
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Sensitivity
• Suicidal Ideation

Intervention

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

Locations

Country	Name	City	State
United States	University of Southern Mississippi	Hattiesburg	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Mississippi	Military Suicide Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

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