NCT02081586

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

June 14, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

March 3, 2014

Results QC Date

April 22, 2016

Last Update Submit

May 12, 2017

Conditions

Diabetes Mellitus, Type 2

Keywords

CBTType 2 DiabetesDiabetes DistressAdherenceSmartphone AppSelf-management

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence

    16 weeks

  • Diabetes Distress Scale- Change Score

    baseline to 16 weeks

  • Body Mass Index Change

    baseline to 16 weeks

Study Arms (4)

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.

Behavioral: CBTDevice: Smartphone appOther: 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.

Behavioral: CBTDevice: Smartphone appOther: 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.

Behavioral: CBTDevice: Smartphone appOther: 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.

Other: Standard Diabetes Care at PCP

Interventions

CBTBEHAVIORAL

Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.

Also known as: Cognitive Behavioral Therapy
12 weeks phone CBT plus smartphone app6 Weeks Phone CBT plus smartphone app8 Weeks Phone CBT plus smartphone app
Smartphone appDEVICE

Smartphone app developed to assist patients practice CBT skills throughout the week

Also known as: CBT Mobile Work
12 weeks phone CBT plus smartphone app6 Weeks Phone CBT plus smartphone app8 Weeks Phone CBT plus smartphone app
Standard Diabetes Care at PCPOTHER

Patients receive ADA standard of Care with physician at PCP office

12 weeks phone CBT plus smartphone app6 Weeks Phone CBT plus smartphone app8 Weeks Phone CBT plus smartphone appStandard Diabetes Care at PCP

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • 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.

    PMID: 36350066DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Pilot study with limited sample size

Results Point of Contact

Title
Dr. Judith A. Callan PhD, RN
Organization
University of Pittsburgh School of Nursing
callanja@pitt.edu
412-383-5321

Study Officials

  • Judith A Callan, PhD

    University of Pittsburgh School of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 7, 2014

Study Start

May 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 14, 2017

Results First Posted

June 14, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)