Evaluating a Mobile Phone Intervention

Study Overview
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Brief Summary
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This clinical trial intends to study the efficacy of a mobile phone delivered intervention in reducing depression-related rumination.

Detailed Description
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Here we propose to test a novel intervention to help individuals manage their depressive rumination. The intervention is based on a just-in-time, adaptive-intervention (JITAI) design. A JITAI is an intervention designed to address the dynamically changing needs of individuals via the provision of the type/amount of support needed, at the right time, and only when needed . This study is also to address one major concern regarding designing JITAI interventions: the burden on participants in having to be engaged with the intervention through diaries, self-reports, and other forms of assessment procedures daily. To reduce this burden, we first pilot test an interactive narrative form. An interactive narrative is an essential form of storytelling that involves certain interactive features such that audiences or readers of the story can have the feeling that they are actively engaging in certain forms of interactions with the story characters. To test the efficacy of such an intervention, there will be a one-month three-arm clinical control trial to reduce depressive rumination. There are three conditions: a JITAI interactive narrative condition, a non-narrative JTIAI condition, and a wait-list control condition. This study could contribute to our knowledge in designing more effective interventions in curbing depression using mobile technology. It can also advance our theoretical knowledge of the role of interactive narratives in reducing user burden in mobile health.

Official Title
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Using Mobile Phones to Reduce Negative Rumination

Conditions
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Depression, Rumination - Thoughts

Intervention / Treatment
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* Behavioral: Mobile-phone delivered Treatment for Excessive Rumination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who have a current self-reported clinical diagnosis of being depressed ( mild to moderate depression and major depressive disorder) Participants should be 18 or older. Participants should have a working smartphone and daily access to the internet. Exclusion Criteria: -Participants who do not have regular access to the internet and a smart phones will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: There are three conditions: a JITAI interactive narrative condition, a JITAI non-narrative condition, and a wait-list control condition.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a JITAI interactive narrative condition (Narrative JITAI)<br>This arm is an exploratory condition, which tested whether story-based JITAI would be an effective way to deal with rumination. | Behavioral: Mobile-phone delivered Treatment for Excessive Rumination<br>* This is a one-month three-arm clinical control trial to reduce the rumination and interpersonal impairment link.<br>|
| Experimental: a JITIAI non-interactive condition<br>This arm uses the regular JITAI ( mobile phone delivered) intervention to provide treatment for ruminative thoughts. | Behavioral: Mobile-phone delivered Treatment for Excessive Rumination<br>* This is a one-month three-arm clinical control trial to reduce the rumination and interpersonal impairment link.<br>|
| No Intervention: a wait-list control condition<br>Participants in this arm will be put on a waitlist without receiving active treatment upon the end of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Rumination focus ( immediately after intervention) | Momentary Ruminative Self-Focus Inventory-Abbreviated (MRSI-A). The MRSI is a 6-item questionnaire measuring state-level fluctuations in ruminative self-focus. Each item ranges from 1 (Strongly disagree) to 7 (Strongly agree). | Change in Rumination focus at the baseline and immediate-post intervention (measured baseline, immediate-post intervention, and two-week follow-up). | 
| Change in Rumination focus ( two weeks after intervention) | Momentary Ruminative Self-Focus Inventory-Abbreviated (MRSI-A). The MRSI is a 6-item questionnaire measuring state-level fluctuations in ruminative self-focus. Each item ranges from 1 (Strongly disagree) to 7 (Strongly agree). | Change in Rumination focus at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up). | 
| Change in Heart-rate( baseline and immediately after intervention) | Participants self-report their heart-rate by using a moblie phone app by the name of Instant Heart rate (see example outcome report: https://www.azumio.com/heartrate/report.jsp?token=28928192047-28935807244-3eb659-334dc9f600fc7084f8cda95b135396673b2bd118-1588095873083#) | Change in heart rates at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up) | 
| Change in Heart-rate (baseline and two weeks after intervention.) | Participants self-report their heart-rate by using a moblie phone app by the name of Instant Heart rate (see example outcome report: https://www.azumio.com/heartrate/report.jsp?token=28928192047-28935807244-3eb659-334dc9f600fc7084f8cda95b135396673b2bd118-1588095873083#) | Change in heart rates at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up). | 
| Change in Depressive Symptoms ( baseline and immediately after intervention) | a 3-item scale in which participants rated their level of depressed mood, anhedonia, and irritability on 7-point Likert scales ranging from 1 (Not at all) to 7 (Very much) at the time of the alert. The SDS is in part modeled after a scale used in a previous EMA study of rumination and depression (Moberly & Watkins, 2008a). The scale was presented as a slider bar on participants' smartphones. | Change in depressive symptoms at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up) | 
| Change in Depressive Symptoms (baseline and two weeks after intervention.) | a 3-item scale in which participants rated their level of depressed mood, anhedonia, and irritability on 7-point Likert scales ranging from 1 (Not at all) to 7 (Very much) at the time of the alert. The SDS is in part modeled after a scale used in a previous EMA study of rumination and depression (Moberly & Watkins, 2008a). The scale was presented as a slider bar on participants' smartphones. | Change in depressive symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up). |