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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

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.


Condition or disease
Diabetes Mellitus, Type 2

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Other
Time Perspective: Other
Official Title: Developing a Positive Psychology Intervention to Improve Health Behaviors in Type 2 Diabetes: Qualitative Research
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Qualitative Interviews



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in anxiety [ Time Frame: Baseline, 3 months ]
    Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)

  2. Change in depression [ Time Frame: Baseline, 3 months ]
    Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)

  3. Change in positive affective [ Time Frame: Baseline, 3 months ]
    Measured by the Positive and Negative Affect Schedule (PANAS)

  4. Change in optimism [ Time Frame: Baseline, 3 months ]
    Measured by the Life Orientation Test-Revised (LOT-R)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetes patients admitted to three inpatient units or seen at the MGH Diabetes Center.
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.
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Responsible Party: Jeff C. Huffman, MD, Medical Director, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03099928    
Other Study ID Numbers: 2014P002578
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases