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

Happify

Status: Terminated

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Happify

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04068805

7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Positive affect condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: Happify

Psychoeducation condition

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Happify