Clinical trial NCT04068805: Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)
Official title: Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Happify Inc.
Sponsor class: INDUSTRY
Collaborators: name: Northwestern University
First posted: 2019-08-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in self-reported HbA1C level
timeFrame: 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:
measure: Change in Depression symptoms [PHQ-9 questionnaire]
timeFrame: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
measure: Change in Diabetes Regimen Adherence
timeFrame: 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)
measure: Change in Perceived Stress [Perceived Stress Scale (PSS)]
timeFrame: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
measure: Change in diabetes self-care activities [Summary of Diabetes Self-Care Activities (SDSCA)]
timeFrame: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
measure: Change in positive affect [Patient-Reported Outcomes Measurement Information Systems - Positive Affect Subscale(PROMIS)]
timeFrame: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Happify (an online platform -- study is entirely online)
state: New York
Study officials:
affiliation: Happify Inc.
name: Eliane Boucher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.