DepressionCBTMobileVNCT04002063
Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Rates of Depression
A study testing CBT MobileWork-V plus CBT and CBT alone in people with Depression, run by VA Office of Research and Development at 9 sites in United States.
Trial summary
Depression is a common psychological disorder seen in 18.5% of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Improving the rate of depression recovery and remission is vital to enhance OEF/OIF/OND Veteran's ability to improve work and home adjustment and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- CBT MobileWork-V plus CBT and CBT alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Oct 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran of OEF/OIF/OND deployments
- Depressive severity of at least 10 on the PHQ-9 at screening (Patient may also have a DSM-5 56 diagnosis of unipolar Major Depression; PTSD; any anxiety disorder; substance/alcohol abuse; or adjustment disorder)
- Ability to read at the eighth grade level and to provide informed consent
- Patients may be taking antidepressants or antianxiety medications where dose has been stable for at least 4 weeks prior to screening evaluation
- Must have an Android smartphone
- Must be willing to be audio-taped for fidelity ratings
Who cannot join
- Diagnoses of schizophrenia, schizo-affective, bipolar, or other psychotic disorder
- Serious suicidal risk (Patient responds positively to PHQ-9 question #9) See B.3.4.1.
- Severe PTSD (Score greater than 51 on PTSD Checklist for DSM-5)
- Severe substance or alcohol dependence (meets DSM-5 criteria of severe)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, 21202
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Coatesville VA Medical Center, Coatesville, PA
Coatesville, Pennsylvania, 19320-2040
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-0001
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422-0001
About this study
Official title: Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Higher Rates of Depression Recovery, Adjustment, and Quality of Life in OEF/OIF Veterans Compared to Standard CBT?
Depression is a common psychological disorder seen in 18.5% of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Improving the rate of depression recovery and remission is vital to enhance OEF/OIF/OND Veteran's ability to improve work and home adjustment and overall quality of life. OEF/OIF/OND Veterans have reported many barriers to following through with Cognitive therapy skills practice assignments, a key component of CBT therapy, the leading therapy for depression in the VA. Smartphone apps have been identified as a useful widely-used tool to improve the effectiveness of psychological treatments. The investigators propose a full-scale multi-site randomized clinical trial (RCT) to measure the efficacy of CBT-D enhanced with CBT MobileWork-V, a comprehensive CBT skill training smartphone app (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D.
Read the detailed description
Cognitive Behavioral Therapy (CBT) is the leading evidence-based psychotherapy for depression, which affects 18.5% of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans (hereafter referred to as OEF/OIF). Yet, OEF/OIF Veterans had only a 30% average reduction in mean depression scores from the initial to later phase of treatment. This was true despite the rigorous training and certification procedures for VA CBT-D. Improving the rate of depression recovery and remission is vital to enhance OEF/OIF Veteran's ability to improve work and home adjustment and overall quality of life.
Broad access to all key ingredients of CBT, including skills practice (homework), is associated with improved and faster recovery from depression. OEF/OIF Veterans and patients with depression have reported many barriers (i.e., time, chaotic lifestyles, and low energy) to following through with their skills practice assignments. In the absence of targeted strategies/interventions to address the barriers that prevent CBT skills practice, OEF/OIF Veterans will remain unable to reap the full benefits/effects of CBT. With specific tailored interventions to address this gap in treatment, OEF/OIF Veterans will improve rates of recovery from depression, diminished home and work adjustment, and poor quality of life.
Leveraging the technological savvy of this generation of Veterans to improve access to CBT skills practice is a logical tactic to address this gap in treatment. Smartphone apps have been identified as a useful widely-used tool to improve the effectiveness of psychological treatments. There is, however, a paucity of empirical studies on the use of mobile apps in the treatment of depressed OEF/OIF Veterans and in psychological treatment overall. The promising pilot results of a comprehensive tailored smartphone app for CBT skills practice for OEF/OIF Veterans ("CBT MobileWork-V"), provides initial evidence for a larger-scale randomized clinical trial (RCT) to measure the efficacy of CBT enhanced with CBTMobileWork-V (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D. Specifically, over a 27-month period the study will randomize 268 eligible OEF/OIF Veterans with depressive symptoms, to either CBT augmented with the comprehensive CBT skill training smartphone app CBT MobileWork-V or standard CBT-D with traditional skills practice methods (i.e., paper and pencil). The Specific Aims of this study are:
Primary Aim 1) To assess whether CBT-D augmented with CBT MobileWork-V (hereafter referred to as CBT-D+) promotes greater CBT understanding and skill acquisition compared to traditional CBT-D.
Primary Aim 2a) To examine the short-term effect in depressive symptoms after 12 weeks of CBT-D+ versus standard CBT-D.
Primary Aim 2b) To examine the long-term effect in depressive symptoms at 6 months post treatment of the CBT-D+ intervention versus traditional CBT-D.
- Conditions
- Depression
- Being tested
- CBT MobileWork-V plus CBT, CBT alone
- Keywords
- Depression, OEF/OIF, Mobile Apps, Cognitive Behavioral Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT MobileWork-V plus CBTBehavioural
a smartphone app to assist with CBT homework skills practice plus CBT
CBT aloneBehavioural
Also called CBT-D
CBT therapy individual
| Study group | Role | What they receive |
|---|---|---|
| CBT-D augmented with CBT MobileWork-V | Experimental | Patients randomized to this condition will receive CBT-D as usual plus access to CBT MobileWork-V, a comprehensive tailored smartphone app for CBT skills practice for OEF/OIF Veterans. Receives: Behavioral: CBT MobileWork-V plus CBT |
| CBT-D | Active comparator | Patients randomized to CBT-D will receive CBT-D as usual only. Receives: Behavioral: CBT MobileWork-V plus CBT; Behavioral: CBT alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skills of Cognitive Therapy (Patient Version)
The Skills of Cognitive Therapy Scale (SoCT) is 8-item self-report (patient version) of a 5-point Likert-type scale ranging from 1 (never) to 5 (always or when needed) assesses patients understanding and use of basic CBT skills in depressed adults. The eight-item SoCT assesses patients' understanding and use of basic cognitive therapy (CT) skills rated from the perspectives of patients (SoCT-P). Ratings of patients' skill usage are made on 5-point Likert-type scales ranging from 1 ("never") to 5 ("always or when needed"). Total scores range 8 - 40. Higher scores reflect greater patient skill in applying cognitive therapy principles and coping strategies.
Measured: week 12
Secondary outcomes (1)
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a screening tool for assessing depression. It is a self-reported questionnaire that helps gauge the severity of depressive symptoms. Components of PHQ-9. Each question asks the patient to rate how often they have been bothered by specific problems over the past two weeks. The total score on the PHQ-9 ranges from 0 to 27.
Interpreting PHQ-9 Scores:
0-4: Minimal or no depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start10 Oct 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- a full-scale multi-site randomized clinical trial (RCT) to measure the efficacy of CBT-D enhanced with CBT MobileWork-V, a comprehensive CBT skill training smartphone app (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Corporal Michael J. Crescenz VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Judith Ann Callan, PhD RN, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002063
- Sponsor's protocol ID
- D2908-R
- Acronym
- CBTMobileV
- Status last verified
- Oct 2025
- First submitted
- 20 Jun 2019
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Higher Rates of Depression Recovery, Adjustment, and Quality of Life in OEF/OIF Veterans Compared to Standard CBT?
- ClinicalTrials.gov ID
- NCT04002063
- Acronym / sponsor ID
- CBTMobileV / D2908-R
- Conditions
- Depression
- Keywords
- Depression, OEF/OIF, Mobile Apps, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Corporal Michael J. Crescenz VA Medical Center
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depression is a common psychological disorder seen in 18.5% of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Improving the rate of depression recovery and remission is vital to enhance OEF/OIF/OND Veteran's ability to improve work and home adjustment and overall quality of life. OEF/OIF/OND Veterans have reported many barriers to following through with Cognitive therapy skills practice assignments, a key component of CBT therapy, the leading therapy for depression in the VA. Smartphone apps have been identified as a useful widely-used tool to improve the effectiveness of psychological treatments. The investigators propose a full-scale multi-site randomized clinical trial (RCT) to measure the efficacy of CBT-D enhanced with CBT MobileWork-V, a comprehensive CBT skill training smartphone app (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D.
Detailed description
Cognitive Behavioral Therapy (CBT) is the leading evidence-based psychotherapy for depression, which affects 18.5% of Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans (hereafter referred to as OEF/OIF). Yet, OEF/OIF Veterans had only a 30% average reduction in mean depression scores from the initial to later phase of treatment. This was true despite the rigorous training and certification procedures for VA CBT-D. Improving the rate of depression recovery and remission is vital to enhance OEF/OIF Veteran's ability to improve work and home adjustment and overall quality of life.
Broad access to all key ingredients of CBT, including skills practice (homework), is associated with improved and faster recovery from depression. OEF/OIF Veterans and patients with depression have reported many barriers (i.e., time, chaotic lifestyles, and low energy) to following through with their skills practice assignments. In the absence of targeted strategies/interventions to address the barriers that prevent CBT skills practice, OEF/OIF Veterans will remain unable to reap the full benefits/effects of CBT. With specific tailored interventions to address this gap in treatment, OEF/OIF Veterans will improve rates of recovery from depression, diminished home and work adjustment, and poor quality of life.
Leveraging the technological savvy of this generation of Veterans to improve access to CBT skills practice is a logical tactic to address this gap in treatment. Smartphone apps have been identified as a useful widely-used tool to improve the effectiveness of psychological treatments. There is, however, a paucity of empirical studies on the use of mobile apps in the treatment of depressed OEF/OIF Veterans and in psychological treatment overall. The promising pilot results of a comprehensive tailored smartphone app for CBT skills practice for OEF/OIF Veterans ("CBT MobileWork-V"), provides initial evidence for a larger-scale randomized clinical trial (RCT) to measure the efficacy of CBT enhanced with CBTMobileWork-V (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D. Specifically, over a 27-month period the study will randomize 268 eligible OEF/OIF Veterans with depressive symptoms, to either CBT augmented with the comprehensive CBT skill training smartphone app CBT MobileWork-V or standard CBT-D with traditional skills practice methods (i.e., paper and pencil). The Specific Aims of this study are:
Primary Aim 1) To assess whether CBT-D augmented with CBT MobileWork-V (hereafter referred to as CBT-D+) promotes greater CBT understanding and skill acquisition compared to traditional CBT-D.
Primary Aim 2a) To examine the short-term effect in depressive symptoms after 12 weeks of CBT-D+ versus standard CBT-D.
Primary Aim 2b) To examine the long-term effect in depressive symptoms at 6 months post treatment of the CBT-D+ intervention versus traditional CBT-D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a full-scale multi-site randomized clinical trial (RCT) to measure the efficacy of CBT-D enhanced with CBT MobileWork-V, a comprehensive CBT skill training smartphone app (the experimental arm) for improving CBT understanding and skill acquisition and depressive symptoms, in OEF/OIF Veterans with depression compared to standard CBT-D.
| Arm | Type | Receives |
|---|---|---|
| CBT-D augmented with CBT MobileWork-V | Experimental | Behavioral: CBT MobileWork-V plus CBTPatients randomized to this condition will receive CBT-D as usual plus access to CBT MobileWork-V, a comprehensive tailored smartphone app for CBT skills practice for OEF/OIF Veterans. |
| CBT-D | Active comparator | Behavioral: CBT MobileWork-V plus CBT, Behavioral: CBT alonePatients randomized to CBT-D will receive CBT-D as usual only. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veteran of OEF/OIF/OND deployments
- Depressive severity of at least 10 on the PHQ-9 at screening (Patient may also have a DSM-5 56 diagnosis of unipolar Major Depression; PTSD; any anxiety disorder; substance/alcohol abuse; or adjustment disorder)
- Ability to read at the eighth grade level and to provide informed consent
- Patients may be taking antidepressants or antianxiety medications where dose has been stable for at least 4 weeks prior to screening evaluation
- Must have an Android smartphone
Key exclusion criteria (4 listed)
- Diagnoses of schizophrenia, schizo-affective, bipolar, or other psychotic disorder
- Serious suicidal risk (Patient responds positively to PHQ-9 question #9) See B.3.4.1.
- Severe PTSD (Score greater than 51 on PTSD Checklist for DSM-5)
- Severe substance or alcohol dependence (meets DSM-5 criteria of severe)
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 |
|---|---|---|
| CBT MobileWork-V plus CBTa smartphone app to assist with CBT homework skills practice plus CBT | Behavioural | CBT-D, CBT-D augmented with CBT MobileWork-V |
| CBT aloneAlso: CBT-DCBT therapy individual | Behavioural | CBT-D |
Primary outcome
Skills of Cognitive Therapy (Patient Version)
Time frame: week 12
The Skills of Cognitive Therapy Scale (SoCT) is 8-item self-report (patient version) of a 5-point Likert-type scale ranging from 1 (never) to 5 (always or when needed) assesses patients understanding and use of basic CBT skills in depressed adults. The eight-item SoCT assesses patients' understanding and use of basic cognitive therapy (CT) skills rated from the perspectives of patients (SoCT-P). Ratings of patients' skill usage are made on 5-point Likert-type scales ranging from 1 ("never") to 5 ("always or when needed"). Total scores range 8 - 40. Higher scores reflect greater patient skill in applying cognitive therapy principles and coping strategies.
1 secondary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Judith Ann Callan, PhD RN principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT MobileWork-V plus CBT and CBT alone in people with Depression, run by VA Office of Research and Development at 9 sites 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 4 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 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Skills of Cognitive Therapy (Patient Version) (time frame: week 12). 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 Oct 2025.