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Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Rates of Depression

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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04002063
Acronym
CBTMobileV
Enrollment
15
Registered
2019-06-28
Start date
2022-10-10
Completion date
2024-03-31
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depression, OEF/OIF, Mobile Apps, Cognitive Behavioral Therapy

Brief 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 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.

Interventions

BEHAVIORALCBT MobileWork-V plus CBT

a smartphone app to assist with CBT homework skills practice plus CBT

BEHAVIORALCBT alone

CBT therapy individual

Sponsors

Corporal Michael J. Crescenz VA Medical Center
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Skills of Cognitive Therapy (Patient Version)week 12The 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.

Secondary

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)week 12The 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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
8
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
7
Total15

Baseline characteristics

CharacteristicCBT-D Augmented With CBT MobileWork-VCBT-DTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
8 Participants7 Participants15 Participants
Dimensions of Anger Reactions11.595 units on a scale
STANDARD_DEVIATION 0.843
12.298 units on a scale
STANDARD_DEVIATION 0.97
11.946 units on a scale
STANDARD_DEVIATION 0.643
GAD21.064 units on a scale
STANDARD_DEVIATION 1.415
17.913 units on a scale
STANDARD_DEVIATION 1.671
19.489 units on a scale
STANDARD_DEVIATION 1.095
Military to Civilian Questionnaire55.230 units on a scale
STANDARD_DEVIATION 3.093
52.608 units on a scale
STANDARD_DEVIATION 1.83
53.919 units on a scale
STANDARD_DEVIATION 1.797
PHQ-915.629 units on a scale
STANDARD_DEVIATION 2.004
20.915 units on a scale
STANDARD_DEVIATION 1.814
17.352 units on a scale
STANDARD_DEVIATION 1.603
PTSD Checklist55.488 units on a scale
STANDARD_DEVIATION 4.282
48.022 units on a scale
STANDARD_DEVIATION 5.203
51.755 units on a scale
STANDARD_DEVIATION 3.369
Quality of Life Questionnaire77.205 units on a scale
STANDARD_DEVIATION 4.016
79.182 units on a scale
STANDARD_DEVIATION 2.875
78.194 units on a scale
STANDARD_DEVIATION 2.47
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
2 Participants4 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
4 Participants2 Participants6 Participants
Sex: Female, Male
Female
2 Participants2 Participants4 Participants
Sex: Female, Male
Male
6 Participants5 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 7
other
Total, other adverse events
0 / 80 / 7
serious
Total, serious adverse events
0 / 80 / 7

Outcome results

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.

Time frame: week 12

ArmMeasureValue (MEAN)Dispersion
CBT-D Augmented With CBT MobileWork-VSkills of Cognitive Therapy (Patient Version)24.231 units on a scaleStandard Deviation 1.495
CBT-DSkills of Cognitive Therapy (Patient Version)24.231 units on a scaleStandard Deviation 1.495
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

Time frame: week 12

ArmMeasureValue (LEAST_SQUARES_MEAN)
CBT-D Augmented With CBT MobileWork-VPatient Health Questionnaire (PHQ-9)23.798 units on a scale
CBT-DPatient Health Questionnaire (PHQ-9)18.004 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026