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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR000146 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institutes of Health (NIH) | NIH |
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This is a pilot study examining the clinical effects of a brief Cognitive Therapy phone approach augmented with a CBT smartphone app geared towards patients with type 2 diabetes patients in poor control.
A significant problem in primary care healthcare delivery is the lack of interventions to improve medication and overall regimen adherence in persons with Type 2 diabetes (T2DM). Diabetes distress, a negative response to the diagnosis of T2DM, danger of complications, and self-management burdens is present in up to 70% of persons with T2DM. Distress is a significant factor in medication nonadherence and poor glycemic control. Treatment adherence is vital to maintain glucose control and reduce complications.
The literature has identified dysfunctional thinking patterns such as beliefs (e.g., I can't handle taking these medications), assumptions (e.g., I know I will have side effects to these medications) and interpretations (e.g., I'm too overwhelmed to do all of this stuff) as critical variables that impact both distress and T2DM treatment adherence. Current treatment strategies within primary care do not address the dysfunctional thinking patterns that affect the patient's distress level, T2DM medication adherence, and complex daily self-care activities.
Cognitive behavior therapy (CBT), a well-established evidenced-based treatment, helps patients to identify, and restructure dysfunctional thinking patterns. The investigators propose to test a brief phone CBT approach that is supported by a comprehensive mobile phone CBT skills practice application (app) within primary care. The promising results of the investigators preliminary studies using a mobile phone app to stimulate real-time CBT skills practice prompt us to propose a pilot of its use with patients with T2DM with the following aims:
Primary aim: examine feasibility and acceptability of the assessment protocol, and the recruitment, and retention of study participants.
Secondary aim: 1) collect preliminary data on the effect of the intervention on clinical outcomes, e.g., self-reported adherence to medication and self-management adherence, e.g., diet, exercise; levels of diabetes distress, diabetes medication beliefs, and distal T2DM outcomes (HbA1c level and body mass index).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 Weeks Phone CBT plus smartphone app | Experimental | 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. |
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| 8 Weeks Phone CBT plus smartphone app | Experimental | 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. |
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| 12 weeks phone CBT plus smartphone app | Experimental | 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. |
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| Standard Diabetes Care at PCP | Active Comparator | Patients will remain in usual care and not receive study intervention. This will include usual diabetes care at PCP. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes. |
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| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Level Change Scores From Baseline to 16 Weeks | Change from baseline HbA1c level to post intervention | baseline to 16 weeks |
| Computer System Usability Questionnaire (CSUQ) | 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence | Electronically 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A Callan, PhD | University of Pittsburgh School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh School of Nursing | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36350066 | Derived | Callan JA, Sereika SM, Cui R, Tamres LK, Tarneja M, Greene B, Van Slyke A, Wu M, Lukac GR, Dunbar-Jacob J. Cognitive Behavioral Therapy (CBT) Telehealth Augmented With a CBT Smartphone Application to Address Type 2 Diabetes Self-Management: A Randomized Pilot Trial. Sci Diabetes Self Manag Care. 2022 Dec;48(6):492-504. doi: 10.1177/26350106221133027. Epub 2022 Nov 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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, Continuous | Mean |
| 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 | HbA1c Level Change Scores From Baseline to 16 Weeks | Change from baseline HbA1c level to post intervention | per protocol | Posted | Mean | Standard Deviation | percent | baseline to 16 weeks |
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| concussion | Nervous system disorders | Non-systematic Assessment | participant fell on ice when going to car and had concussion. He was removed from study due to persistent headache. |
Pilot study with limited sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Judith A. Callan PhD, RN | University of Pittsburgh School of Nursing | 412-383-5321 | callanja@pitt.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Smartphone app | Device | Smartphone app developed to assist patients practice CBT skills throughout the week |
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| Standard Diabetes Care at PCP | Other | Patients receive ADA standard of Care with physician at PCP office |
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| 16 weeks |
| Diabetes Distress Scale- Change Score | 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. | baseline to 16 weeks |
| Body Mass Index Change | Change in Body Mass Index from baseline to post intervention | baseline to 16 weeks |
| Head injury not related to study |
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| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
|
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| Primary | Computer System Usability Questionnaire (CSUQ) | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale (1-7) | 16 weeks |
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| Secondary | MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence | Electronically 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 | Posted | Mean | Full Range | percent adherent | 16 weeks |
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| Secondary | Diabetes Distress Scale- Change Score | 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. | 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. | Posted | Mean | Full Range | percent change | baseline to 16 weeks |
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| Secondary | Body Mass Index Change | Change in Body Mass Index from baseline to post intervention | Of 13 initially randomized, there were 2 dropouts and one was withdrawn from the study. | Posted | Mean | Full Range | kg/m^2 | baseline to 16 weeks |
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| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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 | 0 | 3 | 0 | 3 |
| EG002 | 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 | 0 | 4 | 1 | 4 |
| EG003 | 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 | 0 | 3 | 0 | 3 |
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| D004700 | Endocrine System Diseases |