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Evaluating a Mobile Phone Intervention

NCT ID: NCT04554706

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2021-11-06

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.

Conditions

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Depression Rumination - Thoughts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

There are three conditions: a JITAI interactive narrative condition, a JITAI non-narrative condition, and a wait-list control condition.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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a JITAI interactive narrative condition (Narrative JITAI)

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

Group Type EXPERIMENTAL

Mobile-phone delivered Treatment for Excessive Rumination

Intervention Type BEHAVIORAL

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

a JITIAI non-interactive condition

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

Group Type EXPERIMENTAL

Mobile-phone delivered Treatment for Excessive Rumination

Intervention Type BEHAVIORAL

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

a wait-list control condition

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile-phone delivered Treatment for Excessive Rumination

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

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Lynn Miller

Professor of Communication

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lynn Miller, Ph.D

Role: PRINCIPAL_INVESTIGATOR

UscCalifornia

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26651462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26539566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30739986 (View on PubMed)

Wang L, Miller L. Assessment and Disruption of Ruminative Episodes to Enhance Mobile Cognitive Behavioral Therapy Just-in-Time Adaptive Interventions in Clinical Depression: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Jan 5;7:e37270. doi: 10.2196/37270.

Reference Type DERIVED
PMID: 36602841 (View on PubMed)

Other Identifiers

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UscCalifornia

Identifier Type: -

Identifier Source: org_study_id