Clinical trial NCT04554706: Evaluating a Mobile Phone Intervention
Official title: Using Mobile Phones to Reduce Negative Rumination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Rumination - Thoughts
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: There are three conditions: a JITAI interactive narrative condition, a JITAI non-narrative condition, and a wait-list control condition.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Rumination focus ( immediately after intervention)
timeFrame: Change in Rumination focus at the baseline and immediate-post intervention (measured baseline, immediate-post intervention, and two-week follow-up).
measure: Change in Rumination focus ( two weeks after intervention)
timeFrame: Change in Rumination focus at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
measure: Change in Heart-rate( baseline and immediately after intervention)
timeFrame: Change in heart rates at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up)
measure: Change in Heart-rate (baseline and two weeks after intervention.)
timeFrame: Change in heart rates at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
measure: Change in Depressive Symptoms ( baseline and immediately after intervention)
timeFrame: Change in depressive symptoms at the baseline and immediate-post intervention .(measured baseline, immediate-post intervention, and two-week follow-up)
measure: Change in Depressive Symptoms (baseline and two weeks after intervention.)
timeFrame: Change in depressive symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
Secondary outcomes:
Other outcomes:
measure: Change in Ruminative symptom ( baseline and immediately after intervention)
timeFrame: Change in ruminative symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
measure: Change in Ruminative symptom (baseline and two weeks after intervention.)
timeFrame: Change in ruminative symptoms at the baseline and two weeks after the intervention (measured baseline, immediate-post intervention, and two-week follow-up).
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: UscCalifornia
name: Lynn Miller, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.