Diabetes Mellitus, Type 2NCT02081586

mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study

A study testing CBT, Smartphone app and Standard Diabetes Care at PCP in people with Diabetes Mellitus, Type 2, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: CBT, Smartphone app and Standard Diabetes Care at PCP
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: May 2013to Jul 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

have a diagnosis of T2DM;
have a score of >3 on the Diabetes Distress Scale;
be taking at least one oral antihyperglycemic agent (the patient may also be using injectable antihyperglycemic medications, including insulin);
have an HbA1c level of greater than 8 at baseline;
be receiving treatment for T2DM in the primary care setting;
be aged 30 - 65 years and
be able to read at the 8th-grade level and to provide informed consent. -

Who cannot join

diagnosis of bipolar disorder or schizophrenia; primary diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, substance abuse, or dependence in the last 6 months; or any psychotic disorder;
diabetes treated without oral medications;
inability to read or comprehend English at the 8th-grade level;
refusal to provide informed consent;
dementia or disorders with substantial cognitive impairment; and
serious suicidal risk -

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

Read the detailed description

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).

Conditions: Diabetes Mellitus, Type 2
Being tested: CBT, Smartphone app, Standard Diabetes Care at PCP
Keywords: CBT, Type 2 Diabetes, Diabetes Distress, Adherence, Smartphone App, Self-management
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBTBehavioural
Also called Cognitive Behavioral Therapy
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 appDevice
Also called CBT Mobile Work
Smartphone app developed to assist patients practice CBT skills throughout the week
Standard Diabetes Care at PCPOther
Patients receive ADA standard of Care with physician at PCP office

Study groups in NCT02081586
Study group	Role	What they receive
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. Receives: Behavioral: CBT; Device: Smartphone app; Other: Standard Diabetes Care at PCP
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. Receives: Behavioral: CBT; Device: Smartphone app; Other: Standard Diabetes Care at PCP
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. Receives: Behavioral: CBT; Device: Smartphone app; Other: Standard Diabetes Care at PCP
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. Receives: Other: Standard Diabetes Care at PCP

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c Level Change Scores From Baseline to 16 Weeks
Change from baseline HbA1c level to post intervention
Measured: 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.
Measured: 16 weeks

Secondary outcomes (3)

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
Measured: 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.
Measured: baseline to 16 weeks
Body Mass Index Change
Change in Body Mass Index from baseline to post intervention
Measured: baseline to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Jul 2014

First posted7 Mar 2014 (estimated)
Study startMay 2013
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02081586
Sponsor's protocol ID: PRO13040441
Other IDs: KL2TR000146
Status last verified: May 2017
First submitted: 3 Mar 2014
Last updated: 14 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 36350066

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: mHealth Skill Enhancement Plus Phone CBT for Type 2 Diabetes Distress Medication Nonadherence: Pilot Study
ClinicalTrials.gov ID: NCT02081586
Acronym / sponsor ID: PRO13040441
Conditions: Diabetes Mellitus, Type 2
Keywords: CBT, Type 2 Diabetes, Diabetes Distress, Adherence, Smartphone App, Self-management
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: May 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 7 Mar 2014 (estimated)
Results: Posted 14 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary aim: examine feasibility and acceptability of the assessment protocol, and the recruitment, and retention of study participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
6 Weeks Phone CBT plus smartphone app	Experimental	Behavioral: CBT, Device: Smartphone app, Other: Standard Diabetes Care at PCPFollowing 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.
8 Weeks Phone CBT plus smartphone app	Experimental	Behavioral: CBT, Device: Smartphone app, Other: Standard Diabetes Care at PCPFollowing 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.
12 weeks phone CBT plus smartphone app	Experimental	Behavioral: CBT, Device: Smartphone app, Other: Standard Diabetes Care at PCPFollowing 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.
Standard Diabetes Care at PCP	Active comparator	Other: Standard Diabetes Care at PCPPatients will remain in usual care and not receive study intervention. This will include usual diabetes care at PCP.

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

have a diagnosis of T2DM;
have a score of >3 on the Diabetes Distress Scale;
be taking at least one oral antihyperglycemic agent (the patient may also be using injectable antihyperglycemic medications, including insulin);
have an HbA1c level of greater than 8 at baseline;
be receiving treatment for T2DM in the primary care setting;

Key exclusion criteria (6 listed)

diagnosis of bipolar disorder or schizophrenia; primary diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, substance abuse, or dependence in the last 6 months; or any psychotic disorder;
diabetes treated without oral medications;
inability to read or comprehend English at the 8th-grade level;
refusal to provide informed consent;
dementia or disorders with substantial cognitive impairment; and

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBTAlso: Cognitive Behavioral TherapyTherapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.	Behavioural	12 weeks phone CBT plus smartphone app, 6 Weeks Phone CBT plus smartphone app, 8 Weeks Phone CBT plus smartphone app
Smartphone appAlso: CBT Mobile WorkSmartphone app developed to assist patients practice CBT skills throughout the week	Device	12 weeks phone CBT plus smartphone app, 6 Weeks Phone CBT plus smartphone app, 8 Weeks Phone CBT plus smartphone app
Standard Diabetes Care at PCPPatients receive ADA standard of Care with physician at PCP office	Other	12 weeks phone CBT plus smartphone app, 6 Weeks Phone CBT plus smartphone app, 8 Weeks Phone CBT plus smartphone app, Standard Diabetes Care at PCP

Primary outcome

HbA1c Level Change Scores From Baseline to 16 Weeks
Time frame: baseline to 16 weeks
Change from baseline HbA1c level to post intervention
Computer System Usability Questionnaire (CSUQ)
Time frame: 16 weeks
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.

3 secondary outcomes

MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence
Time frame: 16 weeks
Diabetes Distress Scale- Change Score
Time frame: baseline to 16 weeks
Body Mass Index Change
Time frame: baseline to 16 weeks

Results and safety

Results posted to the registry on 14 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
6 Weeks Phone CBT Plus Smartphone App	3	3
8 Weeks Phone CBT Plus Smartphone App	3	2
12 Weeks Phone CBT Plus Smartphone App	4	3
Treatment as Usual	3	2

Primary outcome: HbA1c Level Change Scores From Baseline to 16 Weeks

Time frame: baseline to 16 weeks. Mean (Standard Deviation). Unit: percent

Measure	6 Weeks Phone CBT Plus Smartphone App n = 3	8 Weeks Phone CBT Plus Smartphone App n = 2	12 Weeks Phone CBT Plus Smartphone App n = 3	Treatment as Usual n = 2
Value	-0.60 (.26)	-2.30 (.00)	-2.33 (.50)	-2.15 (1.63)

Population analysed: per protocol

Primary outcome: Computer System Usability Questionnaire (CSUQ)

Time frame: 16 weeks. Mean (Standard Deviation). Unit: units on a scale (1-7)

Measure	6 Weeks Phone CBT Plus Smartphone App n = 0	8 Weeks Phone CBT Plus Smartphone App n = 0	12 Weeks Phone CBT Plus Smartphone App n = 0	Treatment as Usual n = 0	Participants Administered Phone CBT n = 6
Value	–	–	–	–	3.0 (2.1)

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6 Weeks Phone CBT Plus Smartphone App	0 of 3 (0%)	0 of 3 (0%)	Not reported
8 Weeks Phone CBT Plus Smartphone App	0 of 3 (0%)	0 of 3 (0%)	Not reported
12 Weeks Phone CBT Plus Smartphone App	0 of 4 (0%)	1 of 4 (25%)	Not reported
Treatment as Usual	0 of 3 (0%)	0 of 3 (0%)	Not reported

Limitations and caveats (from the sponsor): Pilot study with limited sample size

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36350066Callan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judith A Callan, PhD principal investigator

University of Pittsburgh School of Nursing

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CBT, Smartphone app and Standard Diabetes Care at PCP in people with Diabetes Mellitus, Type 2, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c Level Change Scores From Baseline to 16 Weeks (time frame: baseline to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02081586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.