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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04068805
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
Happify Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Happify Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Happify
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.

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




Primary Outcome Measures :
  1. Change in Positive Affect [Quality of Life in Neurological Disorders, Positive Affect and Well-being (Neuro-QOL)] [ Time Frame: From start of 8-week intervention (baseline), immediate post-intervention (week 8), 3 month follow up, 6 month follow up, and 12 months post-intervention ]
    9-item measure of positive affect and well-being

  2. Change in Positive Affect [Patient-Reported Outcomes Measurement Information System (PROMIS) positive affect subscale] [ Time Frame: From start of 8-week intervention (baseline), immediate post-intervention (week 8), 3 month follow up, 6 month follow up, and 12 months post-intervention ]
    15-item measure of positive affect


Secondary Outcome Measures :
  1. Self-reported HbA1C levels [ Time Frame: From baseline to 3 months and 6 months post-intervention ]
  2. Change in Depression symptoms (PHQ-9 questionnaire) [ Time Frame: From baseline of 8-week intervention to immediate post-intervention, and at 3, 6, and 12 months post-intervention ]
    9-item measure of depressive symptoms

  3. Change in Depression symptoms (CES-D questionnaire) [ Time Frame: From baseline of 8-week intervention to immediate post-intervention, and at 3, 6, and 12 months post-intervention ]
    20-item measure of depressive symptoms

  4. Change in Diabetes distress [Diabetes distress scale (DDS)] [ Time Frame: From baseline of 8-week intervention to immediate post-intervention, and at 3, 6, and 12 months post-intervention ]
    17-item measure of Diabetes-related disress

  5. Diabetes self-care adherence [Summary of Diabetes Self-Care Adherence (SDSCA)] [ Time Frame: From baseline of 8-week intervention to immediate post-intervention, and at 3, 6, and 12 months post-intervention ]
    11-item measure of Diabetes-related self-care activities

  6. Perceived Stress (Perceived Stress Scale) [ Time Frame: From baseline of 8-week intervention to immediate post-intervention, and at 3, 6, and 12 months post-intervention ]
    10-item measure of perceived stress



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with Type 2 Diabetes
  • No prior experience on the Happify platform (new user registration)

Exclusion Criteria:

  • none
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Responsible Party: Happify Inc.
ClinicalTrials.gov Identifier: NCT04068805    
Other Study ID Numbers: 7
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases