Trial Outcomes & Findings for Does Adding a Tailored Cognitive Behavioral Therapy (CBT) Mobile Skills App Mediate Rates of Depression (NCT NCT04002063)

NCT ID: NCT04002063

Last Updated: 2025-10-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

week 12

Results posted on

2025-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	8	7
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBT-D Augmented With CBT MobileWork-V n=8 Participants 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	CBT-D n=7 Participants 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	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
PHQ-9	15.629 units on a scale STANDARD_DEVIATION 2.004 • n=5 Participants	20.915 units on a scale STANDARD_DEVIATION 1.814 • n=7 Participants	17.352 units on a scale STANDARD_DEVIATION 1.603 • n=5 Participants
Dimensions of Anger Reactions	11.595 units on a scale STANDARD_DEVIATION .843 • n=5 Participants	12.298 units on a scale STANDARD_DEVIATION .970 • n=7 Participants	11.946 units on a scale STANDARD_DEVIATION .643 • n=5 Participants
GAD	21.064 units on a scale STANDARD_DEVIATION 1.415 • n=5 Participants	17.913 units on a scale STANDARD_DEVIATION 1.671 • n=7 Participants	19.489 units on a scale STANDARD_DEVIATION 1.095 • n=5 Participants
PTSD Checklist	55.488 units on a scale STANDARD_DEVIATION 4.282 • n=5 Participants	48.022 units on a scale STANDARD_DEVIATION 5.203 • n=7 Participants	51.755 units on a scale STANDARD_DEVIATION 3.369 • n=5 Participants
Military to Civilian Questionnaire	55.230 units on a scale STANDARD_DEVIATION 3.093 • n=5 Participants	52.608 units on a scale STANDARD_DEVIATION 1.830 • n=7 Participants	53.919 units on a scale STANDARD_DEVIATION 1.797 • n=5 Participants
Quality of Life Questionnaire	77.205 units on a scale STANDARD_DEVIATION 4.016 • n=5 Participants	79.182 units on a scale STANDARD_DEVIATION 2.875 • n=7 Participants	78.194 units on a scale STANDARD_DEVIATION 2.470 • n=5 Participants

PRIMARY outcome

Timeframe: week 12

Outcome measures

Outcome measures
Measure	CBT-D Augmented With CBT MobileWork-V n=8 Participants 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	CBT-D n=7 Participants 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
Skills of Cognitive Therapy (Patient Version)	24.231 units on a scale Standard Deviation 1.495	24.231 units on a scale Standard Deviation 1.495

SECONDARY outcome

Timeframe: week 12

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

Outcome measures

Outcome measures
Measure	CBT-D Augmented With CBT MobileWork-V n=8 Participants 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	CBT-D n=7 Participants 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
Patient Health Questionnaire (PHQ-9)	23.798 units on a scale Interval 19.68 to 27.916	18.004 units on a scale Interval 13.082 to 22.926

Adverse Events

CBT-D Augmented With CBT MobileWork-V

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CBT-D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Judith A. Callan PhD, RN

VHAPTH

Phone: 412-628-1534

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place