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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04068805
• Other study ID #: 7
• Status: Terminated
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: July 12, 2022

Study information

• Verified date: July 2022
• Source: Happify Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 12, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Happify (an online platform -- study is entirely online)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Happify Inc.	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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