Posttraumatic Stress DisorderNCT02954146
Mobile Health Application for Family and Behavioral Health Provider Communication
A study testing Connectd mobile application in people with Posttraumatic Stress Disorder and Anger, run by InferLink Corporation at 1 site in United States.
Trial summary
The purpose of this study is to examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder, Anger
- What is being tested?
- Connectd mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 5 Mar 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
- For Veteran:
- Age 18 or older
- Served in a branch of the US military since October, 2001
- Meets DSM-5 criteria for current PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5);
- Reports at least one episode of anger or irritability in the past week;
- Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
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- Has a family member or friend who also has and uses a smartphone with a data plan and agrees to participate in the study.
- Is able and willing to attend 12 weekly sessions at Duke Psychiatry offices within normal business hours (M-F 8:00-5:00)
- For Collateral:
- 18 years old or older
- Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
- Has a family member or friend who meets the veteran inclusion criteria and agrees to participate in the study.
Who cannot join
- Is currently participating in, or is scheduled to participate in a manualized psychosocial treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University, Department of Psychiatry
Durham, North Carolina, 27705
About this study
The purpose of this study is to examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.
Read the detailed description
Purpose: we will examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.
Participants: (N=100) 50 veterans who have served in the military since October 2001 and have PTSD with anger problems; and 50 collateral family members/close friends above the age of 18.
Procedures (methods): All Veterans with PTSD will receive a 12 session standard CBT for anger. Veterans in the intervention group will additionally receive instructions for using SupportTeam with a family member or friend that will provide data for the CBT clinician. Veterans in the control group will receive the CBT sessions, but will not receive the SupportTeam mobile application.
- Conditions
- Posttraumatic Stress Disorder, Anger
- Being tested
- Connectd mobile application
- Keywords
- Veterans, Posttraumatic Stress Disorder, Anger, Behavioral Health, Mobile Health Technology
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connectd mobile applicationBehavioural
Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review. The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes. In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.
| Study group | Role | What they receive |
|---|---|---|
| CBT only | Active comparator | Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management. Receives: Behavioral: Connectd mobile application |
| CBT + Connectd mobile health app | Experimental | Veterans will receive 12 weekly individual cognitive behavioral therapy (CBT) sessions for anger management. In addition, veterans in this group will also receive instructions for using Connectd mobile health app with a family member or friend that will provide data for the CBT clinician. Receives: Behavioral: Connectd mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Alliance Inventory (Short Form, Therapist)
Documents perspectives of therapist-client relationship
Measured: 12 weeks
Participant Treatment Participation
Number of weekly sessions attended by participants
Measured: 12 weeks
Working Alliance Inventory (Client)
Documents perspectives of therapist-client relationship
Measured: 12 weeks
PTSD Knowledge Scale
Measures general knowledge about PTSD
Measured: 12 weeks
Zarit Burden Interview
Measures stress felt by caregivers
Measured: 12 weeks
Secondary outcomes (2)
Dimensions of Anger Reactions
Measure of anger disposition towards others
Measured: 12 weeks
Clinician-Administered PTSD Scale for DSM5 (CAPS 5)
Assessment of PTSD symptoms
Measured: Past month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InferLink Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Eric Elbogen, PhD, Principal investigator, DukeGreg Barish, PhD, Study chair, InferLink CorporationPatricia E Lester, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954146
- Sponsor's protocol ID
- Pro00069014
- Status last verified
- Mar 2018
- First submitted
- 24 Oct 2016
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Application for Family and Behavioral Health Provider Communication
- ClinicalTrials.gov ID
- NCT02954146
- Acronym / sponsor ID
- Pro00069014
- Conditions
- Posttraumatic Stress Disorder, Anger
- Keywords
- Veterans, Posttraumatic Stress Disorder, Anger, Behavioral Health, Mobile Health Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- InferLink CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Duke University, University of California, Los Angeles
- Study start
- Nov 2016
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 3 Nov 2016 (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 examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.
Detailed description
Purpose: we will examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.
Participants: (N=100) 50 veterans who have served in the military since October 2001 and have PTSD with anger problems; and 50 collateral family members/close friends above the age of 18.
Procedures (methods): All Veterans with PTSD will receive a 12 session standard CBT for anger. Veterans in the intervention group will additionally receive instructions for using SupportTeam with a family member or friend that will provide data for the CBT clinician. Veterans in the control group will receive the CBT sessions, but will not receive the SupportTeam mobile application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT only | Active comparator | Behavioral: Connectd mobile applicationVeterans will receive 12 weekly individual cognitive behavioral therapy (CBT only) sessions for anger management. |
| CBT + Connectd mobile health app | Experimental | Behavioral: Connectd mobile applicationVeterans will receive 12 weekly individual cognitive behavioral therapy (CBT) sessions for anger management. In addition, veterans in this group will also receive instructions for using Connectd mobile health app with a family member or friend that will provide data for the CBT clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 or older
- Served in a branch of the US military since October, 2001
- Meets DSM-5 criteria for current PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5);
- Reports at least one episode of anger or irritability in the past week;
- Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
Key exclusion criteria (1 listed)
- Is currently participating in, or is scheduled to participate in a manualized psychosocial 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 |
|---|---|---|
| Connectd mobile applicationConnectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review. The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes. In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports. | Behavioural | CBT + Connectd mobile health app, CBT only |
Primary outcome
Working Alliance Inventory (Short Form, Therapist)
Time frame: 12 weeks
Documents perspectives of therapist-client relationship
Participant Treatment Participation
Time frame: 12 weeks
Number of weekly sessions attended by participants
Working Alliance Inventory (Client)
Time frame: 12 weeks
Documents perspectives of therapist-client relationship
PTSD Knowledge Scale
Time frame: 12 weeks
Measures general knowledge about PTSD
Zarit Burden Interview
Time frame: 12 weeks
Measures stress felt by caregivers
2 secondary outcomes
Dimensions of Anger Reactions
Time frame: 12 weeks
Clinician-Administered PTSD Scale for DSM5 (CAPS 5)
Time frame: Past month
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 8 Mar 2018.
- 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.
Eric Elbogen, PhD principal investigator
Duke
Greg Barish, PhD study chair
InferLink Corporation
Patricia E Lester, MD study chair
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connectd mobile application in people with Posttraumatic Stress Disorder and Anger, run by InferLink Corporation 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 12 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 8 Mar 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?
Working Alliance Inventory (Short Form, Therapist) (time frame: 12 weeks). 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 8 Mar 2018.