Evaluating a Mobile Phone Intervention

Depression Clinical Trial

Official title:

Using Mobile Phones to Reduce Negative Rumination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554706
• Other study ID #: UscCalifornia
• Status: Completed
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: November 6, 2021

Study information

• Verified date: November 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 6, 2021
• Est. primary completion date: November 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Rumination - Thoughts

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (3)

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:1209-19. doi: 10.1037/hea0000306. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Ruminative symptom ( baseline and immediately after intervention)	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).	Change in ruminative symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
Other	Change in Ruminative symptom (baseline and two weeks after intervention.)	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).	Change in ruminative symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
Primary	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).
Primary	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).
Primary	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)
Primary	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).
Primary	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)
Primary	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).