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Completed

NCT Number: NCT04554706

Evaluating a Mobile Phone Intervention

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Rumination - Thoughts

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile-phone delivered Treatment for Excessive Rumination

Behavioral

This is a one-month three-arm clinical control trial to reduce the rumination and interpersonal impairment link.

Primary outcomes

  1. Change in Rumination focus ( immediately after intervention)

    Time frame: 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).

  2. Change in Rumination focus ( two weeks after intervention)

    Time frame: 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).

  3. Change in Heart-rate( baseline and immediately after intervention)

    Time frame: 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#)

  4. Change in Heart-rate (baseline and two weeks after intervention.)

    Time frame: 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#)

  5. Change in Depressive Symptoms ( baseline and immediately after intervention)

    Time frame: 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."

  6. Change in Depressive Symptoms (baseline and two weeks after intervention.)

    Time frame: 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."

Other outcomes

  1. Change in Ruminative symptom ( baseline and immediately after intervention)

    Time frame: Change in ruminative symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).

    To measure this, we will use the ruminative response scale (RRS), a self-report measure of describing one's responses to depressed mood. It has 22 items, ranging from 1 (not like me at all) to 7 (A lot like me).

  2. Change in Ruminative symptom (baseline and two weeks after intervention.)

    Time frame: Change in ruminative symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).

    To measure this, we will use the ruminative response scale (RRS), a self-report measure of describing one's responses to depressed mood. It has 22 items, ranging from 1 (not like me at all) to 7 (A lot like me).

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Using Mobile Phones to Reduce Negative Rumination

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2020
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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