Anxiety SensitivityM-IBMNCT04129866
Mobile Interpretation Bias Modification Clinical Trial
A study testing M-IBM in people with Anxiety Sensitivity and Suicidal Ideation, run by University of Southern Mississippi at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Sensitivity, Suicidal Ideation
- What is being tested?
- M-IBM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2019to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated ASCC (>2) and include only Guard members who also have current SI (> 0) .
- Ownership of a smartphone
Who cannot join
- those determined by military or study personnel to be actively psychotic, manic, or imminently suicidal and in need of emergency services
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern Mississippi
Hattiesburg, Mississippi, 39406-0002
About this study
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
- Being tested
- M-IBM, Control-IBM
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-IBMBehavioural
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-IBMBehavioural
Placebo IBM where sentences are not related to anxious threat meaning of cue word.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Control-IBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Range 0 - 24, Higher Scores mean more pathology
Measured: 30 minutes
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Range 0 - 24, Higher Scores mean more pathology
Measured: 1 month post intervention
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale
Range 0 - 24, Higher Scores mean more pathology
Measured: 3 months post intervention
The Self-Injurious Thoughts and Behaviors Interview
Measured: 1 month post intervention
The Self-Injurious Thoughts and Behaviors Interview
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start15 Dec 2019
- Primary completion29 Mar 2023 (estimated)
- Study completion29 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Collaborators
- Military Suicide Research Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129866
- Sponsor's protocol ID
- W81XWH-16-2-0004
- Acronym
- M-IBM
- Status last verified
- May 2022
- First submitted
- 10 Oct 2019
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Interpretation Bias Modification Clinical Trial
- ClinicalTrials.gov ID
- NCT04129866
- Acronym / sponsor ID
- M-IBM / W81XWH-16-2-0004
- Conditions
- Anxiety Sensitivity, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Collaborators
- Military Suicide Research Consortium
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 29 Mar 2023 (estimated)
- Study completion
- 29 Mar 2023 (estimated)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-IBM | Experimental | Behavioral: M-IBMM-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 | Placebo comparator | Behavioral: Control-IBMControl-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elevated ASCC (>2) and include only Guard members who also have current SI (> 0) .
- Ownership of a smartphone
Key exclusion criteria (1 listed)
- those determined by military or study personnel to be actively psychotic, manic, or imminently suicidal and in need of emergency services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-IBMIn 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". | Behavioural | M-IBM |
| Control-IBMPlacebo IBM where sentences are not related to anxious threat meaning of cue word. | Behavioural | Control IBM |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-IBM in people with Anxiety Sensitivity and Suicidal Ideation, run by University of Southern Mississippi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Sensitivity Index-3 Cognitive Concerns Subscale (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.