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Evaluating a Mobile Phone Intervention

Primary Purpose

Depression, Rumination - Thoughts

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile-phone delivered Treatment for Excessive Rumination
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

a JITAI interactive narrative condition (Narrative JITAI)

a JITIAI non-interactive condition

a wait-list control condition

Arm Description

This arm is an exploratory condition, which tested whether story-based JITAI would be an effective way to deal with rumination.

This arm uses the regular JITAI ( mobile phone delivered) intervention to provide treatment for ruminative thoughts.

Participants in this arm will be put on a waitlist without receiving active treatment upon the end of the study.

Outcomes

Primary Outcome Measures

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 ( 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 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-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 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 (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."

Secondary Outcome Measures

Full Information

First Posted
June 26, 2020
Last Updated
November 7, 2021
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04554706
Brief Title
Evaluating a Mobile Phone Intervention
Official Title
Using Mobile Phones to Reduce Negative Rumination
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
November 6, 2021 (Actual)
Study Completion Date
November 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Rumination - Thoughts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
There are three conditions: a JITAI interactive narrative condition, a JITAI non-narrative condition, and a wait-list control condition.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participant blind to condition assigned to (compared to alternatives), assignment is automatic/random via computer so investigator blind to participant assignment; analyst is blind to meaning of condition codes.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
a JITAI interactive narrative condition (Narrative JITAI)
Arm Type
Experimental
Arm Description
This arm is an exploratory condition, which tested whether story-based JITAI would be an effective way to deal with rumination.
Arm Title
a JITIAI non-interactive condition
Arm Type
Experimental
Arm Description
This arm uses the regular JITAI ( mobile phone delivered) intervention to provide treatment for ruminative thoughts.
Arm Title
a wait-list control condition
Arm Type
No Intervention
Arm Description
Participants in this arm will be put on a waitlist without receiving active treatment upon the end of the study.
Intervention Type
Behavioral
Intervention Name(s)
Mobile-phone delivered Treatment for Excessive Rumination
Intervention Description
This is a one-month three-arm clinical control trial to reduce the rumination and interpersonal impairment link.
Primary Outcome Measure Information:
Title
Change in Rumination focus ( immediately after intervention)
Description
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).
Time Frame
Change in Rumination focus at the baseline and immediate-post intervention (measured baseline, immediate-post intervention, and two-week follow-up).
Title
Change in Rumination focus ( two weeks after intervention)
Description
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).
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).
Title
Change in Heart-rate( baseline and immediately after intervention)
Description
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#)
Time Frame
Change in heart rates at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up)
Title
Change in Heart-rate (baseline and two weeks after intervention.)
Description
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#)
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).
Title
Change in Depressive Symptoms ( baseline and immediately after intervention)
Description
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."
Time Frame
Change in depressive symptoms at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up)
Title
Change in Depressive Symptoms (baseline and two weeks after intervention.)
Description
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."
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).
Other Pre-specified Outcome Measures:
Title
Change in Ruminative symptom ( baseline and immediately after intervention)
Description
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).
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).
Title
Change in Ruminative symptom (baseline and two weeks after intervention.)
Description
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).
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Miller, Ph.D
Organizational Affiliation
UscCalifornia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because this study is a pilot study, we decided not to share the data.
Citations:
PubMed Identifier
26651462
Citation
Nahum-Shani I, Hekler EB, Spruijt-Metz D. Building health behavior models to guide the development of just-in-time adaptive interventions: A pragmatic framework. Health Psychol. 2015 Dec;34S(0):1209-19. doi: 10.1037/hea0000306.
Results Reference
background
PubMed Identifier
26539566
Citation
Sharmin M, Raij A, Epstien D, Nahum-Shani I, Beck JG, Vhaduri S, Preston K, Kumar S. Visualization of Time-Series Sensor Data to Inform the Design of Just-In-Time Adaptive Stress Interventions. Proc ACM Int Conf Ubiquitous Comput. 2015 Sep;2015:505-516. doi: 10.1145/2750858.2807537.
Results Reference
background
PubMed Identifier
30739986
Citation
Walter N, Murphy ST, Frank LB, Baezconde-Garbanati L. Each Medium Tells a Different Story: The Effect of Message Channel on Narrative Persuasion. Commun Res Rep. 2017;34(2):161-170. doi: 10.1080/08824096.2017.1286471. Epub 2017 Mar 2.
Results Reference
background

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Evaluating a Mobile Phone Intervention

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