AnxietyDARTSNCT01941862
Depression and Anxiety Reduction Treatment for Suicide
A study testing Psychoeducation and Cognitive Bias Modification in people with Anxiety and Depression, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depression, Suicide
- What is being tested?
- Psychoeducation and Cognitive Bias Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2017
- 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
- At or above community sample mean on ASI-3
- At or above community sample mean on INQ-R
- English speakers
- 18 years of age or older
Who cannot join
- Significant medical illness
- Current substance dependence
- Current or past psychotic-spectrum disorders
- Uncontrolled bipolar disorder
- Serious suicidal intent that warranted immediate treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: Development and Evaluation of a Brief, Suicide Prevention Intervention Targeting Anxiety and Mood Vulnerabilities
The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.
Read the detailed description
DARTS is a newly developed computerized treatment targeting specific risk factors associated with suicide, mood, and anxiety symptoms. Eligible individuals will be randomized to one of several conditions. In all conditions, participants will complete various self-report questionnaires and a neurophysiology assessment that involves an EEG. Some participants will also be asked to complete four additional EEG assessments. In addition, all participants will be asked to complete a 1, 3, and 6-month follow-up appointment.
- Conditions
- Anxiety, Depression, Suicide
- Being tested
- Psychoeducation and Cognitive Bias Modification
- Keywords
- computerized intervention, cognitive bias modification, anxiety, mood, perceived burdensomeness, thwarted belongingness, suicide, post-traumatic stress disorder
- Medical subject headings
- Anxiety Disorders, Depression, Suicide, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation and Cognitive Bias ModificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Anxiety Risk Reduction | Experimental | The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced. Receives: Behavioral: Psychoeducation and Cognitive Bias Modification |
| Mood Risk Reduction | Experimental | The mood risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for perceived burdensomeness and thwarted belongingness. The psychoeducational component will focus on dispelling myths related to burdensomeness and belongingness and describe their role in the development of mood symptoms. Receives: Behavioral: Psychoeducation and Cognitive Bias Modification |
| Combined Risk Reduction | Experimental | The combined intervention will involve all of the interventions in the anxiety and mood risk reduction conditions and thus will not be matched for length. Receives: Behavioral: Psychoeducation and Cognitive Bias Modification |
| Repeated Contact Control | No intervention | Participants assigned to the repeated contact group will be assigned a "personal" study coordinator. The coordinator will contact them at specific intervals during the study. The rationale for these contacts will be provided (e.g., checking in on their status and helping to administer some brief measures). During the three weeks (corresponding to treatment session intervals for those in one of the active treatment conditions), the study coordinator will contact the participant once per week for a brief phone check in where suicide risk will be evaluated. Participants in the control group will also meet with their study coordinator during each of the scheduled follow-up visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal Needs Questionnaire (INQ)
The INQ is a 15-item self-report measure of the constructs of thwarted belongingness and perceived burdensomeness as defined by the Interpersonal Theory of Suicide. Van Orden et al. report high internal consistency coefficients for the thwarted belongingness (α=.85) and perceived burdensomeness subscales (α=.89). In support of construct validity, both subscales were found to prospectively predict suicidal ideation.
Measured: Month 6 follow-up
Secondary outcomes (1)
Anxiety Sensitivity Index-3 (ASI-3)
The ASI-3 is an 18-item self-report measure of anxiety sensitivity (AS). This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. Each subfactor is represented by six items. The measure has shown good psychometric properties.
Measured: Month 6 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
- Investigators
- Norman B Schmidt, Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941862
- Sponsor's protocol ID
- W81XWH-10-2-0181
- Acronym
- DARTS
- Status last verified
- Jun 2018
- First submitted
- 20 Jul 2013
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Santopetro NJ, Thompson B, Albanese B, Brush CJ, Schmidt NB. Depression Remission Over Six Months Characterized by Elevated Target-Locked P300 ERP Component: Prospective Evidence Employing an Affective Visual Oddball Task. Psychophysiology. 2025 May;62(5):e70067. doi: 10.1111/psyp.70067.
PubMed 40345151Capron DW, Allan NP, Schmidt NB. The Depression Sensitivity Index: Initial Development and Tests of Convergent and Construct Validity. J Affect Disord. 2021 May 15;287:417-426. doi: 10.1016/j.jad.2021.03.051. Epub 2021 Mar 31.
PubMed 33839487Short NA, Stentz L, Raines AM, Boffa JW, Schmidt NB. Intervening on Thwarted Belongingness and Perceived Burdensomeness to Reduce Suicidality Among Veterans: Subanalyses From a Randomized Controlled Trial. Behav Ther. 2019 Sep;50(5):886-897. doi: 10.1016/j.beth.2019.01.004. Epub 2019 Jan 24.
PubMed 31422845Macatee RJ, Albanese BJ, Clancy K, Allan NP, Bernat EM, Cougle JR, Schmidt NB. Distress intolerance modulation of neurophysiological markers of cognitive control during a complex go/no-go task. J Abnorm Psychol. 2018 Jan;127(1):12-29. doi: 10.1037/abn0000323.
PubMed 29369665Short NA, Boffa JW, Norr AM, Albanese BJ, Allan NP, Schmidt NB. Randomized Clinical Trial Investigating the Effects of an Anxiety Sensitivity Intervention on Posttraumatic Stress Symptoms: A Replication and Extension. J Trauma Stress. 2017 Jun;30(3):296-303. doi: 10.1002/jts.22194. Epub 2017 Jun 6.
PubMed 28585746
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Brief, Suicide Prevention Intervention Targeting Anxiety and Mood Vulnerabilities
- ClinicalTrials.gov ID
- NCT01941862
- Acronym / sponsor ID
- DARTS / W81XWH-10-2-0181
- Conditions
- Anxiety, Depression, Suicide
- Keywords
- computerized intervention, cognitive bias modification, anxiety, mood, perceived burdensomeness, thwarted belongingness, suicide, post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Nov 2013
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Sep 2013 (estimated)
- 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 purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.
Detailed description
DARTS is a newly developed computerized treatment targeting specific risk factors associated with suicide, mood, and anxiety symptoms. Eligible individuals will be randomized to one of several conditions. In all conditions, participants will complete various self-report questionnaires and a neurophysiology assessment that involves an EEG. Some participants will also be asked to complete four additional EEG assessments. In addition, all participants will be asked to complete a 1, 3, and 6-month follow-up appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anxiety Risk Reduction | Experimental | Behavioral: Psychoeducation and Cognitive Bias ModificationThe anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced. |
| Mood Risk Reduction | Experimental | Behavioral: Psychoeducation and Cognitive Bias ModificationThe mood risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for perceived burdensomeness and thwarted belongingness. The psychoeducational component will focus on dispelling myths related to burdensomeness and belongingness and describe their role in the development of mood symptoms. |
| Combined Risk Reduction | Experimental | Behavioral: Psychoeducation and Cognitive Bias ModificationThe combined intervention will involve all of the interventions in the anxiety and mood risk reduction conditions and thus will not be matched for length. |
| Repeated Contact Control | No intervention | –Participants assigned to the repeated contact group will be assigned a "personal" study coordinator. The coordinator will contact them at specific intervals during the study. The rationale for these contacts will be provided (e.g., checking in on their status and helping to administer some brief measures). During the three weeks (corresponding to treatment session intervals for those in one of the active treatment conditions), the study coordinator will contact the participant once per week for a brief phone check in where suicide risk will be evaluated. Participants in the control group will also meet with their study coordinator during each of the scheduled follow-up visits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At or above community sample mean on ASI-3
- At or above community sample mean on INQ-R
- English speakers
- 18 years of age or older
Key exclusion criteria (5 listed)
- Significant medical illness
- Current substance dependence
- Current or past psychotic-spectrum disorders
- Uncontrolled bipolar disorder
- Serious suicidal intent that warranted immediate treatment
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 |
|---|---|---|
| Psychoeducation and Cognitive Bias Modification | Behavioural | Anxiety Risk Reduction, Combined Risk Reduction, Mood Risk Reduction |
Primary outcome
Interpersonal Needs Questionnaire (INQ)
Time frame: Month 6 follow-up
The INQ is a 15-item self-report measure of the constructs of thwarted belongingness and perceived burdensomeness as defined by the Interpersonal Theory of Suicide. Van Orden et al. report high internal consistency coefficients for the thwarted belongingness (α=.85) and perceived burdensomeness subscales (α=.89). In support of construct validity, both subscales were found to prospectively predict suicidal ideation.
1 secondary outcome
Anxiety Sensitivity Index-3 (ASI-3)
Time frame: Month 6 follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Derived from this study: PubMed 40345151Santopetro NJ, Thompson B, Albanese B, Brush CJ, Schmidt NB. Depression Remission Over Six Months Characterized by Elevated Target-Locked P300 ERP Component: Prospective Evidence Employing an Affective Visual Oddball Task. Psychophysiology. 2025 May;62(5):e70067. doi: 10.1111/psyp.70067.
- Derived from this study: PubMed 33839487Capron DW, Allan NP, Schmidt NB. The Depression Sensitivity Index: Initial Development and Tests of Convergent and Construct Validity. J Affect Disord. 2021 May 15;287:417-426. doi: 10.1016/j.jad.2021.03.051. Epub 2021 Mar 31.
- Derived from this study: PubMed 31422845Short NA, Stentz L, Raines AM, Boffa JW, Schmidt NB. Intervening on Thwarted Belongingness and Perceived Burdensomeness to Reduce Suicidality Among Veterans: Subanalyses From a Randomized Controlled Trial. Behav Ther. 2019 Sep;50(5):886-897. doi: 10.1016/j.beth.2019.01.004. Epub 2019 Jan 24.
- Derived from this study: PubMed 29369665Macatee RJ, Albanese BJ, Clancy K, Allan NP, Bernat EM, Cougle JR, Schmidt NB. Distress intolerance modulation of neurophysiological markers of cognitive control during a complex go/no-go task. J Abnorm Psychol. 2018 Jan;127(1):12-29. doi: 10.1037/abn0000323.
- Derived from this study: PubMed 28585746Short NA, Boffa JW, Norr AM, Albanese BJ, Allan NP, Schmidt NB. Randomized Clinical Trial Investigating the Effects of an Anxiety Sensitivity Intervention on Posttraumatic Stress Symptoms: A Replication and Extension. J Trauma Stress. 2017 Jun;30(3):296-303. doi: 10.1002/jts.22194. Epub 2017 Jun 6.
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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.
Norman B Schmidt, Ph.D. principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and Cognitive Bias Modification in people with Anxiety and Depression, run by Florida State University 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Jun 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interpersonal Needs Questionnaire (INQ) (time frame: Month 6 follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01941862, which also lists 5 linked publications.
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 19 Jun 2018.