Evaluating a Mobile Phone Intervention

Not Applicable

Completed

• Conditions: Rumination - Thoughts; Depression
• Interventions: Behavioral: Mobile-phone delivered Treatment for Excessive Rumination

• Registration Number: NCT04554706
• Lead Sponsor: University of Southern California

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-09-13
• Study First Posted: 2020-09-18
• Study Start: 2021-05-06
• Status Verified: 2021-11
• Primary Completion: 2021-11-06
• Study Completion: 2021-11-06
• Last Update Submitted: 2021-11-07
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
a JITAI interactive narrative condition (Narrative JITAI)	Mobile-phone delivered Treatment for Excessive Rumination	This arm is an exploratory condition, which tested whether story-based JITAI would be an effective way to deal with rumination.
a JITIAI non-interactive condition	Mobile-phone delivered Treatment for Excessive Rumination	This arm uses the regular JITAI ( mobile phone delivered) intervention to provide treatment for ruminative thoughts.

Primary Outcome Measures

Name	Time	Method
Change in Rumination focus ( immediately after intervention)	Change in Rumination focus at the baseline and immediate-post intervention (measured baseline, immediate-post intervention, and two-week follow-up).	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 Depressive Symptoms (baseline and two weeks after intervention.)	Change in depressive symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).	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 Heart-rate( baseline and immediately after intervention)	Change in heart rates at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up)	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 Rumination focus ( two weeks after intervention)	Change in Rumination focus at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).	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 Heart-rate (baseline and two weeks after intervention.)	Change in heart rates at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).	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 Depressive Symptoms ( baseline and immediately after intervention)	Change in depressive symptoms at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up)	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."

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States