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Boosting Emotions & Happiness in Outpatients Living With Diabetes (BEHOLD)

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ClinicalTrials.gov Identifier: NCT02736084
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital

Brief Summary:

The investigators developed a novel, telephone-based, 12-week positive psychology intervention and will assess its feasibility and short-term impact in adults with type 2 diabetes (T2D) and suboptimal health behavior adherence. Participants will receive a positive psychology (PP) manual, complete exercises (e.g., writing a gratitude letter, performing acts of kindness), and review these activities by phone with a study trainer over the 12-week study period.

Specific Aim #1 (Feasibility and acceptability (immediate impact); primary aim): To assess whether PP exercises administered over the phone are feasible and linked with immediate benefit in patients with T2D, as measured by ratings provided pre- and post- each exercise.

Hypothesis: The PP exercises will be feasible (i.e., 4 of the 7 PP exercises will be completed by a majority of participants, and participants will have a mean score of at least 7 out of 10 on ratings of ease of completion for the exercises. The PP exercises will also have adequate immediate impact (i.e., mean ratings of 7/10 of exercise utility post-exercise and ratings of optimism post-exercise that are significantly higher than pre-exercise).

Specific Aim #2 (Changes in clinical outcome measures): To determine whether the PP intervention is linked to improvements in psychological well-being, during and after the intervention period (6 & 12 weeks), via measures of optimism, gratitude, depression, and anxiety. To examine whether the brief PP intervention is associated with improvements in self-reported outcomes related to health (diabetes self-care, diabetes distress, health related quality of life), during and after the intervention.

Hypothesis: Participants will have higher mean scores on all psychological outcome measures at 6 and 12 weeks compared to baseline. Participants will also have higher mean scores on all health-related outcome measures at 6 and 12 weeks compared to baseline.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Positive Psychology Not Applicable

Detailed Description:

This is a pilot and feasibility study in adult inpatients and outpatients at MGH. Participants will have Type 2 Diabetes (T2D) and are required to report suboptimal adherence to health behaviors, measured by the Medical Outcomes Study Specific Adherence Scale (MOS SAS). All participants will receive a 12-week PP intervention and pre- and post-intervention assessments of mood and physical symptoms.

Participants will be enrolled from the outpatient Diabetes Center and inpatient medical units of MGH; research staff will introduce the study, assess for inclusion and exclusion criteria, and obtain written informed consent. Post-enrollment, and prior to initiation of the intervention, participants will complete baseline self-report measures of clinical outcomes.

During the initial enrollment visit, participants will receive a treatment manual. In person or by telephone, the study interventionist will review the introductory portion of the manual and discuss the first exercise (Gratitude for Positive Events) with the participant. In subsequent weeks, exercises will be completed independently by participants, recorded in their treatment manual, and then discussed over the phone with their trainer. In the final week, after the final exercise is reviewed, the interventionist and participant will discuss future implementation and ways to incorporate the principles into daily life.

The 12-week intervention will consist of 7 distinct PP exercises, to be completed weekly for the first 4 weeks and then biweekly over the next 8 weeks.

For feasibility, interventionists will record rates of exercise completion at each participant phone session. For acceptability, participants will rate their optimism and positive affect on a 0-10 scale prior to completing the exercise and then immediately following the exercise. Additionally, participants will also rate the ease and overall utility of the exercise on a 0-10 scale after each exercise.

At baseline, 6 weeks, and 12 weeks, non-interventionist study staff obtained the following validated measures of study outcomes:

  • Optimism = Life Orientation Test-Revised (LOT-R)
  • Gratitude = Gratitude Questionnaire-6 (GQ-6)
  • Anxiety and depression = Hospital Anxiety and Depression Scale (HADS)
  • Diabetes-related distress = Diabetes Distress Scale (DDS)
  • Health-related quality of life and function = Patient-Reported Outcomes Measurement Information System physical function scale (PROMIS-PF-10)
  • Diabetes self-care behaviors = Summary of Diabetes Self-Care Activities Measure (SDSCA)
  • Health behavior adherence = Medical Outcomes Study Specific Adherence Scale (MOS SAS)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Positive Psychology Program for Patients With Type 2 Diabetes: A Pilot Study
Study Start Date : August 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Positive Psychology

The Positive Psychology intervention consists of 7 exercises that will be completed by the participant with the guidance of a trainer.

Exercises:

Gratitude for positive events Using personal strengths Gratitude letter Enjoyable and meaningful activities Recalling past success Performing acts of kindness Repeating one of the previous exercises.

Behavioral: Positive Psychology
The Positive Psychology intervention consists of 7 exercises that will be completed by the participant with the guidance of a trainer.




Primary Outcome Measures :
  1. Intervention Feasibility [ Time Frame: 10 Weeks ]
    Rate of intervention feasibility will be measured by the number of exercises completed by each participant. After the exercise, participants will rate the ease of the exercise on a 0-10 Likert scale. Feasibility will be defined as: 4 of the 7 PP exercises will be completed by a majority of patients and subjects will have a mean score of at least 3.5 out of 5 on ratings of ease of completion for the exercises.

  2. Intervention Acceptability [ Time Frame: 10 weeks ]
    To assess acceptability (and immediate impact), participants will rate their optimism and positive affect on a 0-10 Likert scale prior to completing the exercise and then immediately following the exercise. Adequate immediate impact will be defined as: mean ratings of 3.5/5 of exercise utility post-exercise and ratings of optimism post-exercise that are significantly higher than pre-exercise.


Secondary Outcome Measures :
  1. Change in LOT-R Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The Life Orientation Test-Revised (LOT-R) is a validated, six item, self-report measure of optimism.

  2. Change in GQ-6 Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The Gratitude Questionnaire 6 is a brief, validated six-item measure of dispositional gratitude.

  3. Change in HADS Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The Hospital Anxiety and Depression Scale is a validated 14-item measure designed for medically ill patients and has few somatic symptom items.

  4. Change in DDS Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The 17-item Diabetes Distress Scale is a validated scale for use specifically in patients with diabetes

  5. Changes in PROMIS-PF-10 Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    The Patient-Reported Outcomes Measurement Information System physical function scale is an NIH-supported 10-item scale used to asses health-related quality of life and function

  6. Changes in SDSCA Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    11 items from Summary of Diabetes Self-Care Activities Measure Diabetes are used to measure self-care behaviors. Behaviors measured will be diet, physical activity, blood sugar monitoring, and foot care.

  7. Changes in MOS SAS Scores [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    Three Medical Outcomes Study Specific Adherence Scale items assessing medication, diet, and exercise, will be measured individually and as a composite score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current patient of the MGH Diabetes Center or inpatient on Ellison 9-11, White 8-11, Ellison 16, or Bigelow 11
  • Diagnosis of type 2 Diabetes (confirmed via medical record and patient's treatment provider)
  • Age 18 and older
  • Able to read/write in English
  • Suboptimal adherence, defined as a score of 15 or less on three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items related to adherence to medications, diet, and exercise.

Exclusion Criteria:

  • Cognitive disorder precluding informed consent or meaningful participation in the PP exercises, assessed using a six-item cognitive screen developed for research.
  • Lack of telephone access

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736084


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Jeff C Huffman, MD Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeff C. Huffman, MD, Attending Psychiatrist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02736084     History of Changes
Other Study ID Numbers: 2013P001602
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jeff C. Huffman, MD, Massachusetts General Hospital:
optimism
positive affect
adherence
health behavior
diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases