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| Name | Class |
|---|---|
| Corporal Michael J. Crescenz VA Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| CBT-D | Active Comparator | Patients randomized to CBT-D will receive CBT-D as usual only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT MobileWork-V plus CBT | Behavioral | a smartphone app to assist with CBT homework skills practice plus CBT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Ann Callan, PhD RN | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington DC VA Medical Center, Washington, DC | Washington D.C. | District of Columbia | 20422-0001 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT-D Augmented With CBT MobileWork-V | 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. CBT MobileWork-V plus CBT: a smartphone app to assist with CBT homework skills practice plus CBT |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2018 |
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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.
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| CBT alone | Behavioral | CBT therapy individual |
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| week 12 |
| Jesse Brown VA Medical Center, Chicago, IL |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Rehabilitation R&D Service, Baltimore, MD | Baltimore | Maryland | 21202 | United States |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | United States |
| Coatesville VA Medical Center, Coatesville, PA | Coatesville | Pennsylvania | 19320-2040 | United States |
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104-4551 | United States |
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216-7167 | United States |
| Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin | 53295-0001 | United States |
| CBT-D |
Patients randomized to CBT-D will receive CBT-D as usual only. CBT MobileWork-V plus CBT: a smartphone app to assist with CBT homework skills practice plus CBT CBT alone: CBT therapy individual |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT-D Augmented With CBT MobileWork-V | 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. CBT MobileWork-V plus CBT: a smartphone app to assist with CBT homework skills practice plus CBT |
| BG001 | CBT-D | Patients randomized to CBT-D will receive CBT-D as usual only. CBT MobileWork-V plus CBT: a smartphone app to assist with CBT homework skills practice plus CBT CBT alone: CBT therapy individual |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| 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. Interpreting PHQ-9 Scores The total score on the PHQ-9 ranges from 0 to 27.
| Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Dimensions of Anger Reactions | The Dimensions of Anger Reactions Scale (DAR-5) looks at anger over the previous 4 weeks including the frequency, intensity, duration, level of aggression and impact on functioning. It has been validated in Australian populations and is a useful and quick way to assess problematic anger. You will get a total severity score (range 5-25). Higher scores indicate more symptoms and a score above 12 indicates that you are experiencing psychological distress and functional impairment as a result of anger. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| GAD | The Generlized Anxiety Scale (GAD-7) is a widely used self-administered screening tool for Generalized Anxiety Disorder (GAD), designed to assess the severity of anxiety symptoms over the past two weeks. days The total score can range from 0 to 21. Higher scores indicate greater severity of anxiety symptoms. Interpretation of Scores 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety A score of 10 or greater is often used as a threshold for further evaluation, indicating a higher likelihood of GAD. | Mean | Standard Deviation | units on a scale |
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| PTSD Checklist | The Posttraumatic Stress Disorder (PTSD) Checklist is known as the PCL, it is a self-screening tool to help in the diagnosis of PTSD. The score is worked out by adding up the number of points for each answer. The minimum score is 0, the maximum is 80. In addition, a score of 38 or higher indicates probable PTSD in veterans; the score may be set higher or lower for civilians; no agreement has been reached yet since it was only developed after the DSM-5 was published in 2013. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Military to Civilian Questionnaire | Military to Civilian Questionnaire (M2C-Q) is a brief 16-item self-report measure of postemployment reintegration difficulty among veterans. Items are rated on a 5-point likert scale ranging from 0 = no difficulty to 4 = extreme difficulty. Higher scores indicate greater postemployment difficulty. Scores range from 0 to 64, with higher scores indicating greater difficulty with post deployment integration. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Quality of Life Questionnaire | WHOQOL stands for the World Health Organization Quality of Life assessment which measures quality of life across different cultures. It assesses individuals' perceptions of their health and well-being, taking into account various domains of life: physical health, psychological state, social relationships, and environment. WHOQOL (total score 0-100) uses a 5-point Likert scale, where participants rate their responses from 1 to 5, with higher scores indicating better quality of life. The data are scored to yield an overall quality of life score, as well as sub-scores for each of the six domains. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | week 12 |
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | week 12 |
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up to 24 weeks
No adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT-D Augmented With CBT MobileWork-V | 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. CBT MobileWork-V plus CBT: a smartphone app to assist with CBT homework skills practice plus CBT | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | CBT-D | Patients randomized to CBT-D will receive CBT-D as usual only. CBT MobileWork-V plus CBT: a smartphone app to assist with CBT homework skills practice plus CBT CBT alone: CBT therapy individual | 0 | 7 | 0 | 7 | 0 | 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith A. Callan PhD, RN | VHAPTH | 412-628-1534 | judith.callan@va.gov |
| Aug 27, 2025 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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