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

NCT04068805 | Terminated

• 1 other identifier: 7
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Depression symptoms [PHQ-9 questionnaire]

  Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention

• Change in Diabetes Regimen Adherence

  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)]

  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)]

  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)]

  Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention

Study Arms (2)

Positive affect condition

ACTIVE COMPARATOR

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

Psychoeducation condition

SHAM COMPARATOR

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

Interventions

Happify BEHAVIORAL

An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

Positive affect condition; Psychoeducation condition

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Happify Inc.: lead
• Northwestern University: collaborator

Study Sites (1)

Happify (an online platform -- study is entirely online)

New York, New York, 10012, United States

Location

Related Publications (1)

• 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.

  PMID: 32749998 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eliane Boucher, PhD

  Happify Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: August 31, 2020
• Primary Completion: April 1, 2021
• Study Completion: July 12, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

US (1)