Depressive SymptomsNCT05147506
Digital Therapeutic for Depression After Head Injury in Current and Former US Military Personnel
A study testing CNRM DTx and Psychoeducation Comparison in people with Depressive Symptoms and Mild Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
The Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Symptoms, Mild Traumatic Brain Injury
- What is being tested?
- CNRM DTx and Psychoeducation Comparison
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2022to 1 Jan 2025
- 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
- Be aged ≥ 18 to ≤ 65 years
- Be able to provide informed consent
- Diagnosed with mild TBI as defined by the Department of Veteran's Affairs and Department of Defense Clinical Practice
- Have a PHQ-9 score of ≥ 5 to 27, indicative of mild or greater depressive symptoms
- Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
- While participating in this study, be able to ensure that you have access to regular care for mental health and to speak with your provider as necessary
Who cannot join
- Report of starting pharmacological or non-pharmacological treatment for depression within the 3 months prior to trial enrollment
- Report a recent change in type or dose of antidepressant medications within 12 weeks prior to trial enrollment
- Report active psychotic or bipolar symptoms
- Active plan and/or intent of suicide or homicide
- In the opinion of the investigator, they have other considerations that may adversely affect patient safety, participation, or scientific validity of the data being collected
Trial locations and contacts
1 site in 1 country.
United States1 site
Remote Recruitment: Center for Neuroscience and Regenerative Medicine
Bethesda, Maryland, 20851
About this study
Official title: A Single-Blind, Randomized, Controlled Trial of a Cognitive-Behavioral Therapy Digital Therapeutic to Combat Symptoms of Depression in Service Members and Adults With a History of MildTraumatic Brain Injury
The Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx.
Read the detailed description
This trial is a single-blind, randomized, controlled interventional trial of current and former military personnel with symptoms of depression and a history of mTBI. The study will be conducted remotely.
- Conditions
- Depressive Symptoms, Mild Traumatic Brain Injury
- Being tested
- CNRM DTx, Psychoeducation Comparison
- Medical subject headings
- Depression, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNRM DTxDevice
A mobile application intervention adapted from the CBT for Depression and CBT for TBI manuals.
Psychoeducation ComparisonOther
A mobile application that consists of psychoeducational material regarding depression and brain injury.
| Study group | Role | What they receive |
|---|---|---|
| CBT DTx | Experimental | Participants randomized to active intervention will access a structured, cognitive behavioral therapy (CBT) intervention. Receives: Device: CNRM DTx |
| Psychoeducations DTx | Active comparator | Participants randomized to the comparison group will access an unstructured educational DTx. Receives: Other: Psychoeducation Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Measured: Week 12 and Week 16 compared to Baseline
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who complete all treatment modules compared to those who do not
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Measured: Week 12 compared to Baseline
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report history of depression prior to mTBI compared to those who do not
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Measured: Week 12 compared to Baseline
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report family history of depression compared to those who do no
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Measured: Week 12 compared to Baseline
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores, comparison between depression severity group
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Measured: Week 12 compared to Baseline
Secondary outcomes (5)
Change of the mean difference in Traumatic Brain Injury-Quality of Life (TBI-QOL) total score
Computerized adaptive test that measures post-concussive symptoms and quality of life across multiple domains
Measured: Week 12 and Week 16, compared to Baseline
Change of the mean difference in Posttraumatic Stress Disorder Checklist (PCL-5) total score
Self-report measure of PTSD severity; range 0-80; higher score indicates greater severity
Measured: Week 12 and Week 16, compared to Baseline
Change of the mean difference in Insomnia Severity Index (ISI) total score
Self-report measure of insomnia severity; range 0-28; higher score indicates greater severity
Measured: Week 12 and Week 16, compared to Baseline
Change in Credibility and Expectancy Questionnaire (CEQ)
Self-report measure of participation expectation of benefit
Measured: Week 12 and Week 16, compared to Baseline
Blinding Efficacy
Participant blinding questionnaire
Measured: Week 12 and Week 16, compared to Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start22 Jun 2022
- Primary completion30 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Brody, MD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147506
- Sponsor's protocol ID
- CNRM-92-10531
- Status last verified
- Jun 2024
- First submitted
- 20 Jul 2021
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized, Controlled Trial of a Cognitive-Behavioral Therapy Digital Therapeutic to Combat Symptoms of Depression in Service Members and Adults With a History of MildTraumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05147506
- Acronym / sponsor ID
- CNRM-92-10531
- Conditions
- Depressive Symptoms, Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Dec 2021 (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 Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx.
Detailed description
This trial is a single-blind, randomized, controlled interventional trial of current and former military personnel with symptoms of depression and a history of mTBI. The study will be conducted remotely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT DTx | Experimental | Device: CNRM DTxParticipants randomized to active intervention will access a structured, cognitive behavioral therapy (CBT) intervention. |
| Psychoeducations DTx | Active comparator | Other: Psychoeducation ComparisonParticipants randomized to the comparison group will access an unstructured educational DTx. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be aged ≥ 18 to ≤ 65 years
- Be able to provide informed consent
- Diagnosed with mild TBI as defined by the Department of Veteran's Affairs and Department of Defense Clinical Practice
- Have a PHQ-9 score of ≥ 5 to 27, indicative of mild or greater depressive symptoms
- Have ownership of or reliable access to a smartphone with a data plan or internet connecting capabilities
Key exclusion criteria (5 listed)
- Report of starting pharmacological or non-pharmacological treatment for depression within the 3 months prior to trial enrollment
- Report a recent change in type or dose of antidepressant medications within 12 weeks prior to trial enrollment
- Report active psychotic or bipolar symptoms
- Active plan and/or intent of suicide or homicide
- In the opinion of the investigator, they have other considerations that may adversely affect patient safety, participation, or scientific validity of the data being collected
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 |
|---|---|---|
| CNRM DTxA mobile application intervention adapted from the CBT for Depression and CBT for TBI manuals. | Device | CBT DTx |
| Psychoeducation ComparisonA mobile application that consists of psychoeducational material regarding depression and brain injury. | Other | Psychoeducations DTx |
Primary outcome
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score
Time frame: Week 12 and Week 16 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who complete all treatment modules compared to those who do not
Time frame: Week 12 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report history of depression prior to mTBI compared to those who do not
Time frame: Week 12 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores of participants who report family history of depression compared to those who do no
Time frame: Week 12 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total scores, comparison between depression severity group
Time frame: Week 12 compared to Baseline
Self-report measure of depression symptom severity; range 0-27; higher score indicates greater severity
5 secondary outcomes
Change of the mean difference in Traumatic Brain Injury-Quality of Life (TBI-QOL) total score
Time frame: Week 12 and Week 16, compared to Baseline
Change of the mean difference in Posttraumatic Stress Disorder Checklist (PCL-5) total score
Time frame: Week 12 and Week 16, compared to Baseline
Change of the mean difference in Insomnia Severity Index (ISI) total score
Time frame: Week 12 and Week 16, compared to Baseline
Change in Credibility and Expectancy Questionnaire (CEQ)
Time frame: Week 12 and Week 16, compared to Baseline
Blinding Efficacy
Time frame: Week 12 and Week 16, compared to Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Yes. Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository.
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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.
David Brody, MD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CNRM DTx and Psychoeducation Comparison in people with Depressive Symptoms and Mild Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine 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 6 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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?
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?
Change of the mean difference in Patient Health Questionnaire (PHQ-9) total score (time frame: Week 12 and Week 16 compared to Baseline). 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 13 Jun 2024.