Boosting Emotions & Happiness in Outpatients Living With Diabetes

NCT02736084 | Completed

• 1 other identifier: 2013P001602
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

optimism; positive affect; adherence; health behavior; diabetes

Outcome Measures

Primary Outcomes (2)

• Intervention Feasibility

  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

  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 Outcomes (7)

• Change in LOT-R Scores

  Baseline, 6 weeks, and 12 weeks

• Change in GQ-6 Scores

  Baseline, 6 weeks, and 12 weeks

• Change in HADS Scores

  Baseline, 6 weeks, and 12 weeks

• Change in DDS Scores

  Baseline, 6 weeks, and 12 weeks

• Changes in PROMIS-PF-10 Scores

  Baseline, 6 weeks, and 12 weeks

Study Arms (1)

Positive Psychology

EXPERIMENTAL

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

Interventions

Positive Psychology BEHAVIORAL

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

Positive Psychology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• DuBois CM, Millstein RA, Celano CM, Wexler DJ, Huffman JC. Feasibility and Acceptability of a Positive Psychological Intervention for Patients With Type 2 Diabetes. Prim Care Companion CNS Disord. 2016 May 5;18(3):10.4088/PCC.15m01902. doi: 10.4088/PCC.15m01902. eCollection 2016.

  PMID: 27733954 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Health Behavior; Diabetes Mellitus

Interventions

Psychology, Positive

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 13, 2016
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 13, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)