Evaluating a Mobile Phone Intervention

NCT04554706 | Completed

• 1 other identifier: UscCalifornia
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Rumination - Thoughts

Outcome Measures

Primary Outcomes (6)

• 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).

Other Outcomes (2)

• Change in Ruminative symptom ( baseline and immediately after intervention)

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

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

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

Study Arms (3)

a JITAI interactive narrative condition (Narrative JITAI)

EXPERIMENTAL

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

a JITIAI non-interactive condition

EXPERIMENTAL

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

Behavioral: Mobile-phone delivered Treatment for Excessive Rumination

a wait-list control condition

NO INTERVENTION

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

Interventions

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.

a JITAI interactive narrative condition (Narrative JITAI); a JITIAI non-interactive condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who do not have regular access to the internet and a smart phones will be excluded.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90007, United States

Location

Related Publications (4)

• 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.

  PMID: 26651462 BACKGROUND

• 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.

  PMID: 26539566 BACKGROUND

• 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.

  PMID: 30739986 BACKGROUND

• 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.

  PMID: 36602841 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Lynn Miller, Ph.D

  UscCalifornia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Communication

Model Details: There are three conditions: a JITAI interactive narrative condition, a JITAI non-narrative condition, and a wait-list control condition.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: September 18, 2020
• Study Start: May 6, 2021
• Primary Completion: November 6, 2021
• Study Completion: November 6, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)