DepressionMARIGOLDNCT02861755
Online Positive Emotion Skills Intervention for Symptoms of Depression
A study testing Positive Affect Skills Training and 5-week Emotion Reporting in people with Depression and Psychological Stress, run by Northwestern University at 1 site in United States.
Trial summary
Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans with depression receive adequate treatment, and one-third of those receiving treatment do not benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Psychological Stress, Affect
- What is being tested?
- Positive Affect Skills Training and 5-week Emotion Reporting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 677 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2018
- 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
- Daily internet access
- Cell phone ownership
- Score of 5 or higher on PHQ-8 scale
- Lives in US or Canada
- Speaks and reads English, able to provide informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, Feinberg School of Medicine, MSS Dept
Chicago, Illinois, 60611
About this study
Official title: Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)
Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans with depression receive adequate treatment, and one-third of those receiving treatment do not benefit. In this pilot project investigators will bring together two approaches that have the promise to reach large numbers of depression sufferers: a skills-based intervention for increasing positive affect and experiences in depressed individuals, delivered in an inexpensive self-paced mobile format. The study will make use of smartphone technology to improve conventional outcome measurement via in-the-moment emotion sampling and mobile assessment of heart rate variability, a predictor of cardiac health that may mediate some of the health effects of depression. The aims are: 1) Retool the existing web-based positive emotion intervention for use on smartphones, with innovative exercises that help participants bring the skills they are learning into real-life situations; 2) Perform a small feasibility trial of the mobile intervention on individuals with clinical depression recruited online 3) Eventually incorporate feedback from the small feasibility trial to improve the online intervention and conduct a full randomized trial on a larger scale
- Conditions
- Depression, Psychological Stress, Affect
- Being tested
- Positive Affect Skills Training, 5-week Emotion Reporting
- Keywords
- Depression, Depressive Disorder, Psychological Stress, Behavioral Symptoms, Mental Disorders, Mood Disorders
- Medical subject headings
- Depression, Stress, Psychological, Depressive Disorder, Behavioral Symptoms, Mental Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Affect Skills TrainingBehavioural
Blend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges.
5-week Emotion ReportingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | The MARIGOLD positive emotions course plus a blend of enhancements to include: 5-minutes of weekly facilitator contact, online discussion board, or gamification through virtual flower badges. Receives: Behavioral: Positive Affect Skills Training |
| Arm 2 | Experimental | Emotion reporting control condition. Reporting daily emotions for the same duration of the online emotions course. Receives: Behavioral: 5-week Emotion Reporting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Retention Over Time (average of 4.5 months through study completion)
Determine the percentage of participants providing data at each stage of the study from baseline to study completion (average of 4.5 months). This includes capturing dropout rates and reasons for dropping out, where possible; Retention will also include analyzing any qualitative comments/feedback on the lessons and home practice exercises in order to gauge what participants like and don't like, and what is feasible for future iterations of this study to maximize retention.
Measured: From the start of the 5-week online intervention (Weeks 1-5), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). Data collected for the duration of the entire study.
Change in Depression symptoms (PHQ-8 questionnaire) Over Time (4.5 months through study completion)
8-items; responses range from 0 "not at all" to 3 "almost every day"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Depression symptoms (CES-D questionnaire) Over Time
20-items; responses range from 1 "rarely or none of the time (less than 1 day)" to 3 "occasionally or a moderate amount of the time (3-4 days)"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Secondary outcomes (15)
Change in Stress: Perceived Stress Scale (PSS questionnaire) Over Time
10-items; responses range from 1 "never" to 5 "very often"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Positive and Negative Affect (DES questionnaire) Over Time ("past week")
26-items; responses range from 1 "not at all" to 9 "all the time"; framed as "Over the PAST week, how much have you felt each of these emotions?"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Mindfulness Over Time: Five Facet Mindfulness Questionnaire (FFMQ)
7-items; responses range from 1 "never or rarely true" to 5 "very often or always true"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Prioritizing Positivity Over Time (Prioritizing Positivity Scale)
6-items; responses range from 1 "disagree strongly" to 9 "agree strongly"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Skills Use Questionnaire (measuring change in application/use of positive affect skills over 4.5 months)
10-items; responses range from 1 "definitely false" to 5 "definitely true"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Brief Resilience Scale (BRS) over time (4.5 months of participation in the study)
6-items of self-reported resilience; responses range from 1 "strongly disagree" to 5 "strongly agree"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Depression Self Stigma Scale (DSSS) over time (4.5 months of participation in the study)
32-item scale to measure self stigma of depression; responses range from 1 "completely disagree" to 7 "completely agree"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Meaning and Purpose Scale over time (4.5 months of participation in the study)
8-item scale with 5 response options ranging from "strongly disagree" to "strongly agree"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Positive Affect and Well-Being Short Form from the Neuro-QOL Item Bank
9-item scale measuring positive affect and well-being with 5 response options: "never" "rarely" "sometimes" "often" "always"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in General Behavior Inventory (GBI) Scale
7-item instrument assessing for symptoms of mania with 7 response options: 0 "Never or hardly ever," 1 "Sometimes," 2 "Often," 3 "Very Often," 7 "Don't Know," 8 "Refuse to Answer," 9 "Not applicable." The 7 items include questions such as: "Have there been times lasting several days or more when you felt you must have lots of excitement, and you actually did a lot of new or different things?"
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Behavioral Activation for Depression Scale (BADS)
9-item instrument that measures the impact of behavioral activation on depressive symptoms. Response items range from 0 to 6, from "Not at all" to "Completely." Statements include: "I was an active person and accomplished the goals I set out to do" and "I did things that were enjoyable."
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Stress Management Self-Efficacy (SMSE)
4-item instrument that measures the impact of stress on depressive symptoms. Response scale ranges from 1 "strongly agree" to 4 "strongly disagree." Items include: 1) I believe I have the ability to cope with the demands of my life 2) I know when I'm starting to experience too much stress 3) I know how to cope with stress when it comes and 4) I am usually able to successfully deal with my stress levels.
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Expectancy Credibility Scale
6-item instrument that measures how expectancy and credibility might influence participants' responses. Responses range from 1 "Not at all" to 9 "Very." Statements include: "At this point, how logical does this course seem to you?" or "At this point, how much do you really feel that the course will help you to improve your functioning?"
Measured: Administered once at the initial questionnaire prior to Week 1 of the intervention.
Change in Self Compassion Scale (SCS) Short-Form
12-item instrument assesses levels of self-compassion. Response items range from 1 "Almost never" to 5 "Almost always." Statements include: "I try to see my failings as part of the human condition" and "When something painful happens I try to take a balanced view of the situation."
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Self-Stigma Depression Scale (SSDS)
16-item instrument that assesses levels of self-stigma surrounding depressive symptoms. This measure will be used to replace the DSSS from the pilot phase of the study.
Measured: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Moskowitz, Northwestern University
- Investigators
- Judith T Moskowitz, PhD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861755
- Sponsor's protocol ID
- STU00092507
- Other IDs
- R34MH101265-02
- Acronym
- MARIGOLD
- Status last verified
- Oct 2023
- First submitted
- 13 Jun 2016
- Last updated
- 27 Oct 2023
- Results posted
- No
Publications
Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676-92. doi: 10.1177/1359105311425275. Epub 2011 Oct 21.
PubMed 22021272Moskowitz JT, Jackson K, Freedman ME, Grote VE, Kwok I, Schuette SA, Cheung EO, Addington EL. Positive Psychological Intervention Effects on Depression: Positive Emotion Does Not Mediate Intervention Impact in a Sample with Elevated Depressive Symptoms. Affect Sci. 2022 Oct 6;4(1):163-173. doi: 10.1007/s42761-022-00140-7. eCollection 2023 Mar.
PubMed 37070017Moskowitz JT, Addington EL, Shiu E, Bassett SM, Schuette S, Kwok I, Freedman ME, Leykin Y, Saslow LR, Cohn MA, Cheung EO. Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Sep 22;23(9):e25922. doi: 10.2196/25922.
PubMed 34550076Cheung EO, Addington EL, Bassett SM, Schuette SA, Shiu EW, Cohn MA, Leykin Y, Saslow LR, Moskowitz JT. A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD. JMIR Res Protoc. 2018 Jun 5;7(6):e10494. doi: 10.2196/10494.
PubMed 29871853
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Positive Emotion Skills Intervention for Symptoms of Depression (MARIGOLD)
- ClinicalTrials.gov ID
- NCT02861755
- Acronym / sponsor ID
- MARIGOLD / STU00092507
- Conditions
- Depression, Psychological Stress, Affect
- Keywords
- Depression, Depressive Disorder, Psychological Stress, Behavioral Symptoms, Mental Disorders, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Mental Health (NIMH)
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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.
Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans with depression receive adequate treatment, and one-third of those receiving treatment do not benefit. In this pilot project investigators will bring together two approaches that have the promise to reach large numbers of depression sufferers: a skills-based intervention for increasing positive affect and experiences in depressed individuals, delivered in an inexpensive self-paced mobile format. The study will make use of smartphone technology to improve conventional outcome measurement via in-the-moment emotion sampling and mobile assessment of heart rate variability, a predictor of cardiac health that may mediate some of the health effects of depression. The aims are: 1) Retool the existing web-based positive emotion intervention for use on smartphones, with innovative exercises that help participants bring the skills they are learning into real-life situations; 2) Perform a small feasibility trial of the mobile intervention on individuals with clinical depression recruited online 3) Eventually incorporate feedback from the small feasibility trial to improve the online intervention and conduct a full randomized trial on a larger scale
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Positive Affect Skills TrainingThe MARIGOLD positive emotions course plus a blend of enhancements to include: 5-minutes of weekly facilitator contact, online discussion board, or gamification through virtual flower badges. |
| Arm 2 | Experimental | Behavioral: 5-week Emotion ReportingEmotion reporting control condition. Reporting daily emotions for the same duration of the online emotions course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Daily internet access
- Cell phone ownership
- Score of 5 or higher on PHQ-8 scale
- Lives in US or Canada
- Speaks and reads English, able to provide informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Positive Affect Skills TrainingBlend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges. | Behavioural | Arm 1 |
| 5-week Emotion Reporting | Behavioural | Arm 2 |
Primary outcome
Change in Retention Over Time (average of 4.5 months through study completion)
Time frame: From the start of the 5-week online intervention (Weeks 1-5), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). Data collected for the duration of the entire study.
Determine the percentage of participants providing data at each stage of the study from baseline to study completion (average of 4.5 months). This includes capturing dropout rates and reasons for dropping out, where possible; Retention will also include analyzing any qualitative comments/feedback on the lessons and home practice exercises in order to gauge what participants like and don't like, and what is feasible for future iterations of this study to maximize retention.
Change in Depression symptoms (PHQ-8 questionnaire) Over Time (4.5 months through study completion)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
8-items; responses range from 0 "not at all" to 3 "almost every day"
Change in Depression symptoms (CES-D questionnaire) Over Time
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
20-items; responses range from 1 "rarely or none of the time (less than 1 day)" to 3 "occasionally or a moderate amount of the time (3-4 days)"
15 secondary outcomes
Change in Stress: Perceived Stress Scale (PSS questionnaire) Over Time
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Positive and Negative Affect (DES questionnaire) Over Time ("past week")
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Mindfulness Over Time: Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Prioritizing Positivity Over Time (Prioritizing Positivity Scale)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Skills Use Questionnaire (measuring change in application/use of positive affect skills over 4.5 months)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Brief Resilience Scale (BRS) over time (4.5 months of participation in the study)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Depression Self Stigma Scale (DSSS) over time (4.5 months of participation in the study)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Meaning and Purpose Scale over time (4.5 months of participation in the study)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Positive Affect and Well-Being Short Form from the Neuro-QOL Item Bank
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in General Behavior Inventory (GBI) Scale
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Behavioral Activation for Depression Scale (BADS)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Stress Management Self-Efficacy (SMSE)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Expectancy Credibility Scale
Time frame: Administered once at the initial questionnaire prior to Week 1 of the intervention.
Change in Self Compassion Scale (SCS) Short-Form
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Change in Self-Stigma Depression Scale (SSDS)
Time frame: From the start of the 5-week online intervention (Week 1), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Background: PubMed 22021272Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676-92. doi: 10.1177/1359105311425275. Epub 2011 Oct 21.
- Derived from this study: PubMed 37070017Moskowitz JT, Jackson K, Freedman ME, Grote VE, Kwok I, Schuette SA, Cheung EO, Addington EL. Positive Psychological Intervention Effects on Depression: Positive Emotion Does Not Mediate Intervention Impact in a Sample with Elevated Depressive Symptoms. Affect Sci. 2022 Oct 6;4(1):163-173. doi: 10.1007/s42761-022-00140-7. eCollection 2023 Mar.
- Derived from this study: PubMed 34550076Moskowitz JT, Addington EL, Shiu E, Bassett SM, Schuette S, Kwok I, Freedman ME, Leykin Y, Saslow LR, Cohn MA, Cheung EO. Facilitator Contact, Discussion Boards, and Virtual Badges as Adherence Enhancements to a Web-Based, Self-guided, Positive Psychological Intervention for Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Sep 22;23(9):e25922. doi: 10.2196/25922.
- Derived from this study: PubMed 29871853Cheung EO, Addington EL, Bassett SM, Schuette SA, Shiu EW, Cohn MA, Leykin Y, Saslow LR, Moskowitz JT. A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD. JMIR Res Protoc. 2018 Jun 5;7(6):e10494. doi: 10.2196/10494.
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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.
Judith T Moskowitz, PhD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Affect Skills Training and 5-week Emotion Reporting in people with Depression and Psychological Stress, run by Northwestern University 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 27 Oct 2023. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Retention Over Time (average of 4.5 months through study completion) (time frame: From the start of the 5-week online intervention (Weeks 1-5), post-intervention (Week 6), 1 month followup (Week 10), 3 month followup (Week 18). Data collected for the duration of the entire study.). The study lists 3 primary outcomes in all. 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 NCT02861755, which also lists 4 linked publications.
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 27 Oct 2023.