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

April 7, 2016 updated by: Jeff C. Huffman, MD, Massachusetts General Hospital

A Positive Psychology Program for Patients With Type 2 Diabetes: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 Weeks
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.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, and 12 weeks
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.
Baseline, 6 weeks, and 12 weeks
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.
Baseline, 6 weeks, and 12 weeks
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
Baseline, 6 weeks, and 12 weeks
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
Baseline, 6 weeks, and 12 weeks
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.
Baseline, 6 weeks, and 12 weeks
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.
Baseline, 6 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 7, 2016

First Posted (ESTIMATE)

April 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P001602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Positive Psychology

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe