ExperimentalNCT03579706
Evaluation of a Brief, Online Intervention for Military Personnel
A study testing Cognitive Anxiety Sensitivity Treatment and Physical Health Education Training in people with Experimental and Placebo Contol, run by Florida State University at 1 site in United States.
Trial summary
This randomized controlled trial will compare the effectiveness and acceptability of a computerized treatment targeting anxiety sensitivity compared to an active control: Physical Health Education Treatment (PHET) to determine efficacy among military personnel when delivered over the Internet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Experimental, Placebo Contol
- What is being tested?
- Cognitive Anxiety Sensitivity Treatment and Physical Health Education Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2018to 1 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- current or past member of the U.S. military
- elevated anxiety sensitivity as indexed by ASI-3 cognitive concerns subscale
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
This randomized controlled trial will compare the effectiveness and acceptability of a computerized treatment targeting anxiety sensitivity compared to an active control: Physical Health Education Treatment (PHET) to determine efficacy among military personnel when delivered over the Internet.
Purpose: To investigate the efficacy and acceptability of a computerized stress sensitivity treatment delivered online among a population of U.S. military personnel.
Read the detailed description
The objective of the current proposal is to evaluate the efficacy of the Cognitive Anxiety Sensitivity Treatment (CAST) program in an online RCT through Amazon's Mechanical Turk with Veterans and military personnel. The primary outcome variables will be traumatic stress, anxiety, and depressive symptoms. The study is being conducted at Florida State University.
Specific Aims: (1) Evaluate the efficacy of the CAST program delivered over the Internet among Veterans and military personnel; (2) Assess acceptability and usability of the CAST program delivered over the Internet without in person appointments; (3) Determine the feasibility of using Amazon's Mechanical Turk to recruit and conduct a fully online randomized controlled trial of a computerized treatment.
Veterans or active duty personnel (N = 100) who are at increased risk for mental health problems, as indicated by elevated anxiety sensitivity, will be recruited through Amazon's Mechanical Turk. Mechanical Turk is an online marketplace for individuals interested in completing computerized tasks, such as research surveys, for compensation. Participants will complete self-report symptom measures before and after the intervention as well as at a 4-month follow-up appointment. The intervention is a single session and lasts approximately 45 minutes. The intervention contains educational material to dispel commonly held false beliefs about the dangerousness of experiencing anxiety symptoms, for example elevated heart rate or a difficulty concentrating. Then participants are guided through an exercise designed to bring on these uncomfortable bodily sensations to help participants reduce the amount of distress these symptoms cause. Participants will also be asked to provide feedback related to acceptability and usability of the intervention.
- Conditions
- Experimental, Placebo Contol
- Being tested
- Cognitive Anxiety Sensitivity Treatment, Physical Health Education Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Anxiety Sensitivity TreatmentBehavioural
The Cognitive Anxiety Sensitivity Treatment is a computerized treatment that is a combination of psychoeducation plus interoceptive exposure 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.
Physical Health Education TrainingBehavioural
The Physical Health Education Training is a computerized active placebo matched in time and structure to CAST that includes information about general health and wellness (e.g. diet, exercise etc.).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention condition will involve participants completing baseline measures, the Cognitive Anxiety Sensitivity Treatment, post measures, and a 4 month follow up assessment. Receives: Behavioral: Cognitive Anxiety Sensitivity Treatment |
| Control | Placebo comparator | The control condition will involve participants completing baseline measures, the Physical Health Education Training, post measures, and a 4 month follow up assessment. Receives: Behavioral: Physical Health Education Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Sensitivity
The Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007) is an 18-item self-report measure of 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. The measure has shown good psychometric properties (Taylor et al., 2007).
Measured: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Secondary outcomes (5)
Change in Anxiety Symptoms
The Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer et al., 2006) is a 7- item self-report measure of generalized anxiety. Participants rate the frequency with which they experience anxiety-related symptoms on a scale of 0 (Not at all) to 3 (Nearly every day). The GAD-7 exhibited excellent internal consistency and good test-retest reliability (Spitzer et al., 2006). Total scores range from 0-21 with higher scores indicating greater anxiety symptoms.
Measured: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Change in Depressive Symptoms Module (PHQ-9).
The Patient Health Questionnaire - Depression (PHQ-9) is the 9-item depression module of the larger Patient Health Questionnaire (PHQ;Spitzer et al., 1999) which was designed to assess eight DSM-IV diagnoses, including major depressive disorder. The PHQ-9 exhibited excellent internal reliability and excellent test-retest reliability (Kroenke et al., 2001). Total scores range from 0-27 with higher scores indicating greater depressive symptoms.
Measured: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Change in Post-Traumatic Stress Disorder Symptoms
The Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a brief, 20-item self-report instrument that assesses the 20 DSM-5 symptoms of posttraumatic stress disorder. We will use the PCL-5 to obtain total symptom severity scores and DSM-5 symptom cluster severity scores for each participant.
Measured: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Usability of the computerized intervention
The System Usability Scale (SUS) is a 10 item self-report questionnaire assessing general usability of a given program (Brooke, 1996). The SUS total score ranges from 5 to 50 with higher scores indicating better usability.
Measured: Immediately post intervention
Client Satisfaction
The Client Satisfaction Questionnaire (CSQ) is an 8 item self-report questionnaire assessing general satisfaction with services of treatment received by the individual (Attkisson and Zwick, 1982). The CSQ has shown high reliability and internal consistency (Attkisson and Zwick, 1982). Total score ranges from 8 to 32 with higher scores indicating greater satisfaction.
Measured: Immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start25 Jun 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExperimentalStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
- Investigators
- Norman B Schmidt, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579706
- Sponsor's protocol ID
- Norr02
- Status last verified
- Feb 2020
- First submitted
- 1 Jun 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Brief, Online Intervention for Military Personnel
- ClinicalTrials.gov ID
- NCT03579706
- Acronym / sponsor ID
- Norr02
- Conditions
- Experimental, Placebo Contol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 6 Jul 2018 (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.
This randomized controlled trial will compare the effectiveness and acceptability of a computerized treatment targeting anxiety sensitivity compared to an active control: Physical Health Education Treatment (PHET) to determine efficacy among military personnel when delivered over the Internet.
Purpose: To investigate the efficacy and acceptability of a computerized stress sensitivity treatment delivered online among a population of U.S. military personnel.
Detailed description
The objective of the current proposal is to evaluate the efficacy of the Cognitive Anxiety Sensitivity Treatment (CAST) program in an online RCT through Amazon's Mechanical Turk with Veterans and military personnel. The primary outcome variables will be traumatic stress, anxiety, and depressive symptoms. The study is being conducted at Florida State University.
Specific Aims: (1) Evaluate the efficacy of the CAST program delivered over the Internet among Veterans and military personnel; (2) Assess acceptability and usability of the CAST program delivered over the Internet without in person appointments; (3) Determine the feasibility of using Amazon's Mechanical Turk to recruit and conduct a fully online randomized controlled trial of a computerized treatment.
Veterans or active duty personnel (N = 100) who are at increased risk for mental health problems, as indicated by elevated anxiety sensitivity, will be recruited through Amazon's Mechanical Turk. Mechanical Turk is an online marketplace for individuals interested in completing computerized tasks, such as research surveys, for compensation. Participants will complete self-report symptom measures before and after the intervention as well as at a 4-month follow-up appointment. The intervention is a single session and lasts approximately 45 minutes. The intervention contains educational material to dispel commonly held false beliefs about the dangerousness of experiencing anxiety symptoms, for example elevated heart rate or a difficulty concentrating. Then participants are guided through an exercise designed to bring on these uncomfortable bodily sensations to help participants reduce the amount of distress these symptoms cause. Participants will also be asked to provide feedback related to acceptability and usability of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cognitive Anxiety Sensitivity TreatmentThe intervention condition will involve participants completing baseline measures, the Cognitive Anxiety Sensitivity Treatment, post measures, and a 4 month follow up assessment. |
| Control | Placebo comparator | Behavioral: Physical Health Education TrainingThe control condition will involve participants completing baseline measures, the Physical Health Education Training, post measures, and a 4 month follow up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- current or past member of the U.S. military
- elevated anxiety sensitivity as indexed by ASI-3 cognitive concerns subscale
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Cognitive Anxiety Sensitivity TreatmentThe Cognitive Anxiety Sensitivity Treatment is a computerized treatment that is a combination of psychoeducation plus interoceptive exposure 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. | Behavioural | Intervention |
| Physical Health Education TrainingThe Physical Health Education Training is a computerized active placebo matched in time and structure to CAST that includes information about general health and wellness (e.g. diet, exercise etc.). | Behavioural | Control |
Primary outcome
Change in Anxiety Sensitivity
Time frame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
The Anxiety Sensitivity Index - 3 (ASI-3; Taylor et al., 2007) is an 18-item self-report measure of 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. The measure has shown good psychometric properties (Taylor et al., 2007).
5 secondary outcomes
Change in Anxiety Symptoms
Time frame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Change in Depressive Symptoms Module (PHQ-9).
Time frame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Change in Post-Traumatic Stress Disorder Symptoms
Time frame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU
Usability of the computerized intervention
Time frame: Immediately post intervention
Client Satisfaction
Time frame: Immediately post intervention
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 17 Feb 2020.
- 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.
Norman B Schmidt, PhD 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 Cognitive Anxiety Sensitivity Treatment and Physical Health Education Training in people with Experimental and Placebo Contol, 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 3 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: finished, as of the sponsor's last update on 17 Feb 2020. 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?
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?
Change in Anxiety Sensitivity (time frame: Baseline; change from baseline to immediately post intervention, change from baseline to 4 month FU). 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 17 Feb 2020.