Trial Outcomes & Findings for mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study (NCT NCT02081586)
NCT ID: NCT02081586
Last Updated: 2017-06-14
Results Overview
The CSUQ measures feasibility and acceptability of the phone application. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean value, range is from 1 to 7. In this adaptation lower scores are better usability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
16 weeks
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
6 Weeks Phone CBT Plus Smartphone App
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
2
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
6 Weeks Phone CBT Plus Smartphone App
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Head injury not related to study
|
0
|
0
|
1
|
0
|
Baseline Characteristics
mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study
Baseline characteristics by cohort
| Measure |
6 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
n=4 Participants
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
n=3 Participants
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
50.67 years
STANDARD_DEVIATION 12.34 • n=7 Participants
|
59.50 years
STANDARD_DEVIATION 3.42 • n=5 Participants
|
60.67 years
STANDARD_DEVIATION .58 • n=4 Participants
|
57.38 years
STANDARD_DEVIATION 6.64 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
13 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline to 16 weeksPopulation: per protocol
Change from baseline HbA1c level to post intervention
Outcome measures
| Measure |
6 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
n=2 Participants
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
n=2 Participants
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Participants Administered Phone CBT
This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
|
|---|---|---|---|---|---|
|
HbA1c Level Change Scores From Baseline to 16 Weeks
|
-0.60 percent
Standard Deviation .26
|
-2.30 percent
Standard Deviation .00
|
-2.33 percent
Standard Deviation .50
|
-2.15 percent
Standard Deviation 1.63
|
—
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: As per protocol, usability was analyzed for participants administered phone CBT, regardless of duration. Six subjects completed the CSUQ. Of ten initially assigned treatment, one was withdrawn prior to treatment, one missed the CSUQ, and two dropped out. Treatment as usual Arm did not use the phone.
The CSUQ measures feasibility and acceptability of the phone application. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean value, range is from 1 to 7. In this adaptation lower scores are better usability.
Outcome measures
| Measure |
6 Weeks Phone CBT Plus Smartphone App
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Participants Administered Phone CBT
n=6 Participants
This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
|
|---|---|---|---|---|---|
|
Computer System Usability Questionnaire (CSUQ)
|
—
|
—
|
—
|
—
|
3.0 units on a scale (1-7)
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 16 weeksElectronically measured medication adherence, percent adherence over entire study phase. Change score was not evaluated, this measure is to determine feasability of use over time. Percent adherence is measured by the number of correct doses per day divided by the number of prescribed doses per day X 100. Percent adherence was calculated as the percentage of the prescribed doses of the medication actually taken by the patient over 16 weeks
Outcome measures
| Measure |
6 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
n=2 Participants
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
n=2 Participants
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Participants Administered Phone CBT
This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
|
|---|---|---|---|---|---|
|
MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence
|
37.7 percent adherent
Interval 20.2 to 56.2
|
35.7 percent adherent
Interval 15.8 to 55.7
|
88.69 percent adherent
Interval 79.0 to 96.1
|
84.06 percent adherent
Interval 77.9 to 90.2
|
—
|
SECONDARY outcome
Timeframe: baseline to 16 weeksPopulation: Of thirteen initially randomized, one was withdrawn prior to treatment, one is missing data, and two dropped out. Therefore we do not have change scores for these pariticipants.
Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Percent change of mean score between baseline and 16 weeks is reported. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.
Outcome measures
| Measure |
6 Weeks Phone CBT Plus Smartphone App
n=2 Participants
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
n=2 Participants
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
n=2 Participants
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Participants Administered Phone CBT
This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
|
|---|---|---|---|---|---|
|
Diabetes Distress Scale- Change Score
|
-17.98 percent change
Interval -20.4 to -15.58
|
-8.33 percent change
Interval -37.7 to 21.1
|
-40.92 percent change
Interval -65.3 to -1.3
|
-36.22 percent change
Interval -39.6 to -32.8
|
—
|
SECONDARY outcome
Timeframe: baseline to 16 weeksPopulation: Of 13 initially randomized, there were 2 dropouts and one was withdrawn from the study.
Change in Body Mass Index from baseline to post intervention
Outcome measures
| Measure |
6 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
n=2 Participants
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
n=3 Participants
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
n=2 Participants
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Participants Administered Phone CBT
This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
|
|---|---|---|---|---|---|
|
Body Mass Index Change
|
.23 kg/m^2
Interval 0.1 to 0.3
|
-1.2 kg/m^2
Interval -1.3 to -1.1
|
.53 kg/m^2
Interval -2.2 to 2.1
|
.35 kg/m^2
Interval 0.1 to 0.6
|
—
|
Adverse Events
6 Weeks Phone CBT Plus Smartphone App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
8 Weeks Phone CBT Plus Smartphone App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 Weeks Phone CBT Plus Smartphone App
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
6 Weeks Phone CBT Plus Smartphone App
n=3 participants at risk
Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
8 Weeks Phone CBT Plus Smartphone App
n=3 participants at risk
Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
12 Weeks Phone CBT Plus Smartphone App
n=4 participants at risk
Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.
CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
Treatment as Usual
n=3 participants at risk
Patients will remain in usual care and not receive study intervention.
Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office
|
|---|---|---|---|---|
|
Nervous system disorders
concussion
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
Additional Information
Dr. Judith A. Callan PhD, RN
University of Pittsburgh School of Nursing
Phone: 412-383-5321
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place