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Mobile Interpretation Bias Modification Clinical Trial (M-IBM)

Primary Purpose

Anxiety Sensitivity, Suicidal Ideation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
M-IBM
Control-IBM
Sponsored by
University of Southern Mississippi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Sensitivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern Mississippi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

M-IBM

Control IBM

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Range 0 - 24, Higher Scores mean more pathology
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Range 0 - 24, Higher Scores mean more pathology
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Range 0 - 24, Higher Scores mean more pathology
The Self-Injurious Thoughts and Behaviors Interview
The Self-Injurious Thoughts and Behaviors Interview

Secondary Outcome Measures

Full Information

First Posted
October 10, 2019
Last Updated
May 26, 2022
Sponsor
University of Southern Mississippi
Collaborators
Military Suicide Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT04129866
Brief Title
Mobile Interpretation Bias Modification Clinical Trial
Acronym
M-IBM
Official Title
Mobile Interpretation Bias Modification Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
March 29, 2023 (Anticipated)
Study Completion Date
March 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Mississippi
Collaborators
Military Suicide Research Consortium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Sensitivity, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M-IBM
Arm Type
Experimental
Arm Description
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).
Arm Title
Control IBM
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
M-IBM
Intervention Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Control-IBM
Intervention Description
Placebo IBM where sentences are not related to anxious threat meaning of cue word.
Primary Outcome Measure Information:
Title
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Description
Range 0 - 24, Higher Scores mean more pathology
Time Frame
30 minutes
Title
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Description
Range 0 - 24, Higher Scores mean more pathology
Time Frame
1 month post intervention
Title
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Description
Range 0 - 24, Higher Scores mean more pathology
Time Frame
3 months post intervention
Title
The Self-Injurious Thoughts and Behaviors Interview
Time Frame
1 month post intervention
Title
The Self-Injurious Thoughts and Behaviors Interview
Time Frame
3 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Southern Mississippi
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39406-0002
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mobile Interpretation Bias Modification Clinical Trial

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