Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Developing a Positive Psychology Intervention to Improve Health Behaviors in Type 2 Diabetes: Qualitative Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099928
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date March 29, 2017
First Posted Date April 4, 2017
Last Update Posted Date May 16, 2017
Actual Study Start Date March 1, 2015
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2017)
Qualitative data [ Time Frame: Baseline ]
Themes related to: Positive psychological states, barriers to health behaviors, relationships between positive states and barriers to health behaviors, and feedback about potential PP exercises
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 29, 2017)
  • Change in anxiety [ Time Frame: Baseline, 3 months ]
    Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
  • Change in depression [ Time Frame: Baseline, 3 months ]
    Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)
  • Change in positive affective [ Time Frame: Baseline, 3 months ]
    Measured by the Positive and Negative Affect Schedule (PANAS)
  • Change in optimism [ Time Frame: Baseline, 3 months ]
    Measured by the Life Orientation Test-Revised (LOT-R)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Developing a Positive Psychology Intervention to Improve Health Behaviors in Type 2 Diabetes: Qualitative Research
Official Title Developing a Positive Psychology Intervention to Improve Health Behaviors in Type 2 Diabetes: Qualitative Research
Brief Summary

Specific Aim #1 (Qualitative Research): To identify, through qualitative research, deficits in positive affect and associated barriers to completing health behaviors in type 2 DM patients.

Hypothesis: Patients will be able to complete the structured interview, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers to completing such behaviors.

Specific Aim #2 (Creation of intervention): To use the data gathered from qualitative and quantitative measures to create a positive psychology-based intervention

Hypothesis: Using the information provided in this trial, the investigators will be able to create an intervention, composed of several positive psychology exercises, that is well-matched with a diabetic population and is targeted to the enhancement adherence to health-related behaviors in this population. This intervention will then be ready for next stage testing.

Detailed Description

The investigators are proposing to enroll 31 patients with type 2 DM following an outpatient visit to the MGH Diabetes Center or during admission to Ellison 9-11 inpatient units (or sometime in the following 14 days if the participant is not available to complete the interview after consenting for the study).

For these interviews, the investigators will discuss positive emotional states that patients have experienced and talk about ways they might increase these states. The investigators will also touch on health behaviors in which the patient has engaged and whether positive emotions played a role in completing these behaviors. To enhance the accessibility of this project, the investigators chose to allow patients to complete interviews over the phone. Interactions by phone (rather than in-person visits) can allow for patients who are being discharged from the hospital or have no time to complete the interview during a clinic visit.

The investigators will also conduct a follow up phone call 3 months post-hospitalization during which the investigators will collect mood and anxiety data from participants. The purpose of this data will be to better characterize the population, allowing the investigators to better customize the intervention for this population.

There are two study visits (the first of which can be broken into two parts if the participant cannot complete the interview in the hospital after consenting to the study). The first visit will consist of three brief scales of mood and anxiety (Hospital Anxiety and Depression Scale, Positive and Negative Affect Schedule, and Life Orientation Test-Revised) that will take 10 minutes, followed by a 45 minute interview. Participants also will report their race and ethnicity. The second visit will take place 3 months after the initial visit and will be conducted over the phone. This second visit will consist of the same three brief scales of mood and anxiety.

Baseline Data: Baseline information about enrolled subjects will also be obtained from the patients, care providers, the structured assessments of mood and anxiety symptoms as above, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of cardiac illness, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (admission diagnosis if applicable, HbA1c), medications, length of hospital stay if applicable, and sociodemographic data (age, gender, race/ethnicity, living alone). This information will help the investigators to ensure that the population the investigators recruit is a representative population of patients with type 2 DM.

Qualitative Data: Subjects will undergo an open-ended, one-hour structured interview. The interview will be performed by study staff trained in qualitative research methods by the study PI, Dr. Huffman, using frameworks from Dr. Huffman's prior work. First, subjects will be asked open-ended questions about positive emotional/cognitive experiences. Interviewers will ask about subjects' experience with positive thoughts and feelings recently, and will attempt to elicit both the frequency/intensity of such experiences and the range of such states (e.g., elation vs. optimism). Next, subjects will be asked in an open-ended manner about ideas that they may have to increase the frequency and breadth of their own positive experiences, and then will be asked their opinion about the potential utility of several different existing positive psychology exercises. The interviewers will then inquire about the impact that positive thoughts/feelings may have on our specific diabetes-related health behaviors of interest.

Follow-up 3 Month Phone Call: Three months after discharge from the hospital, a study RA will call subjects to repeat the measures of mood and anxiety completed at baseline (HADS, PANAS, and LOT-R). The investigators will record specific times at enrollment that subjects would prefer to be called (and not to be called) to reduce intrusion on subjects' lives. The investigators will also remind subjects of their upcoming call, in case they need to reschedule. If subjects would rather complete the questions in written form rather than over the phone, the investigators will send them a written packet at the time of each follow-up.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Type 2 diabetes patients admitted to three inpatient units or seen at the MGH Diabetes Center.
Condition Diabetes Mellitus, Type 2
Intervention Not Provided
Study Groups/Cohorts Qualitative Interviews
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2017)
31
Original Actual Enrollment Same as current
Actual Study Completion Date November 30, 2016
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients (21 years and older) admitted to one of the inpatient cardiac units (Ellison 9, 10, or11) at MGH or a current outpatient in the MGH Diabetes Center. Patients must have Type 2 Diabetes (confirmed via medical record and diabetologist/attending physician).
  • Suboptimal adherence to health behaviors (diabetic diet, physical activity, medication), as measured by the Medical Outcomes Study Specific Adherence Scale (MOS SAS), as denoted by a score of <15 out of 18.

Exclusion Criteria:

  • Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.24-26
  • Medical conditions precluding interviews, determined in consultation with attending physician or diabetologist.
  • Inability to communicate in English.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03099928
Other Study ID Numbers 2014P002578
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jeff C. Huffman, MD, Massachusetts General Hospital
Study Sponsor Massachusetts General Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Massachusetts General Hospital
Verification Date May 2017