Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)

Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires before, during, and after the 8-week program, as well as at 3 months, 6 months, and 12 months after the end of the program.

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Happify

Detailed Description

Participants will be randomly assigned to either the Diabetes positive affect skills intervention or a psychoeducation control group. Both programs last 8 weeks and take place on a simplified research version of the Happify platform. Participants assigned to the diabetes positive affect program will have full access to Happify, with a track that focuses on building skills for greater happiness, reducing stress, and coping better with diabetes displayed as the feature track. Participants assigned to the psychoeducation (control) condition will be asked to complete a series of polls on various wellbeing topics, and then provided with some social comparison data about how their responses compared with the responses of other users, as well as information about why the well being topic is important. Participants will be asked to complete questionnaires before, during, and after the 8-week program as well as 3 months, 6 months and 12 months follow-up questionnaires after the program is complete, at which point study participation will end.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10012
      • Happify (an online platform -- study is entirely online)

Participation Criteria

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:

• Adults with Type 2 Diabetes
• Elevated HbA1c levels (7 or greater)
• No prior experience on the Happify platform (new user registration)
• PHQ-8 score of 13 or higher
• US resident
• Under the care of a medical professional for the treatment of their diabetes
• Be willing and able to obtain HbA1c every 3 months

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Positive affect condition; Participants use Happify and have the option to use a diabetes-specific track that focuses on building skills for greater happiness, reducing stress, and coping better with diabetes. Users may access a wide variety of 4-week programs and use them in any way they desire for the entire study period.	Behavioral: Happify; An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
Sham Comparator: Psychoeducation condition; Participants complete a series of quizzes and polls on Happify designed to engage them in thinking about well-being topics, but without giving any specific instructions for how to promote well-being. Participants gain access to 8 weeks worth of content, but may repeat the content as often as they like in the follow-up period.	Behavioral: Happify; An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported HbA1C level	1-item self-reported measure of Hemoglobin A1C (HbA1C) level, "What was your most recent HbA1c level?"	Baseline, 3 weeks post-intervention (day 83), 3 weeks after 3-month post intervention (day 173), 3 weeks after 6 month post intervention (day 263), and 12 months post intervention (day 416)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression symptoms [PHQ-9 questionnaire]	9-item measure of depressive symptoms scoring how often the participant has been bothered by each statement over the past 2 weeks from not at all (0) to nearly every day (3).	Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Change in Diabetes Regimen Adherence	1-item measure on keeping up with diabetes regimen in the past 24 hours, asking "Which of the following activities in your diabetes regimen did you complete over the past 24 hours?"	From baseline up to 63 days, 7 days at 3 months post intervention (146-153), 7 days at 6 months post intervention (236-243), and 12 months post intervention (day 416-423)
Change in Perceived Stress [Perceived Stress Scale (PSS)]	10-item measure of perceived stress scoring how often the participant felt stressed by each statement in the following month from never (0) to very often (4).	Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Change in diabetes self-care activities [Summary of Diabetes Self-Care Activities (SDSCA)]	11-item measure of self-reported adherence to diabetes self-care activities, ex. "On how many of the last seven days did you participate in at least 30 minutes of physical activity?" with possible answers of 0 to 7 days for each question.	Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Change in positive affect [Patient-Reported Outcomes Measurement Information Systems - Positive Affect Subscale(PROMIS)]	15-item measure of positive affect scoring participants on how often then felt each statement was true over the past 7 days from not at all (1) to very much (5)	Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention

Collaborators and Investigators

• Sponsor: Happify Inc.
• Collaborators: Northwestern University

Publications and helpful links

General Publications

• Boucher E, Moskowitz JT, Kackloudis GM, Stafford JL, Kwok I, Parks AC. Immediate and Long-Term Effects of an 8-Week Digital Mental Health Intervention on Adults With Poorly Managed Type 2 Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 4;9(8):e18578. doi: 10.2196/18578.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): July 12, 2022

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No