Diabetes Mellitus, Type 2NCT04068805
Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)
A study testing Happify in people with Diabetes Mellitus, Type 2, run by Happify Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Happify
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Happify (an online platform -- study is entirely online)
New York, New York, 10012
About this study
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.
Read the 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
- Being tested
- Happify
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HappifyBehavioural
An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Positive affect condition | Active comparator | 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. Receives: Behavioral: Happify |
| Psychoeducation condition | Sham comparator | 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. Receives: Behavioral: Happify |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported HbA1C level
1-item self-reported measure of Hemoglobin A1C (HbA1C) level, "What was your most recent HbA1c level?"
Measured: 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 (5)
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).
Measured: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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?"
Measured: 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)
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).
Measured: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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.
Measured: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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)
Measured: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start31 Aug 2020
- Primary completion1 Apr 2021
- Study completion12 Jul 2022
Why it stopped: The Sponsor chose to terminate this study for commercial reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happify Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Eliane Boucher, PhD, Principal investigator, Happify Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068805
- Sponsor's protocol ID
- 7
- Status last verified
- Jul 2022
- First submitted
- 23 Aug 2019
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32749998
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)
- ClinicalTrials.gov ID
- NCT04068805
- Acronym / sponsor ID
- 7
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor chose to terminate this study for commercial reasons.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Happify Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Positive affect condition | Active comparator | Behavioral: HappifyParticipants 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. |
| Psychoeducation condition | Sham comparator | Behavioral: HappifyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HappifyAn online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction. | Behavioural | Positive affect condition, Psychoeducation condition |
Primary outcome
Change in self-reported HbA1C level
Time frame: 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)
1-item self-reported measure of Hemoglobin A1C (HbA1C) level, "What was your most recent HbA1c level?"
5 secondary outcomes
Change in Depression symptoms [PHQ-9 questionnaire]
Time frame: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Change in Diabetes Regimen Adherence
Time frame: 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)
Change in Perceived Stress [Perceived Stress Scale (PSS)]
Time frame: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Change in diabetes self-care activities [Summary of Diabetes Self-Care Activities (SDSCA)]
Time frame: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Change in positive affect [Patient-Reported Outcomes Measurement Information Systems - Positive Affect Subscale(PROMIS)]
Time frame: Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
Results and safety
The study was stopped early (reason given: The Sponsor chose to terminate this study for commercial reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 32749998Boucher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliane Boucher, PhD principal investigator
Happify Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happify in people with Diabetes Mellitus, Type 2, run by Happify Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Sponsor chose to terminate this study for commercial reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported HbA1C level (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.