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

NCT ID: NCT04068805

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2022-07-12

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.

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Happify

Intervention Type: BEHAVIORAL

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

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.

Group Type: SHAM_COMPARATOR

Happify

Intervention Type: BEHAVIORAL

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

Interventions

Happify

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

Happify Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eliane Boucher, PhD

Role: PRINCIPAL_INVESTIGATOR

Happify Inc.

Locations

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

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32749998 (View on PubMed)

Other Identifiers

7

Identifier Type: -

Identifier Source: org_study_id