Study Protocol for a Smartphone Application-based Intervention for Subthreshold Depression

NCT04136041 | Completed

• 1 other identifier: 19-33
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to conduct a randomized controlled trial to examine whether a Smartphone-based Intervention improves subthreshold depression symptoms compared to no intervention. The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.

Conditions

Subthreshold Depression

Outcome Measures

Primary Outcomes (1)

• Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.

  The CES-D is a 20-item self-report questionnaire used to measure depressive symptoms. The CES-D is a four-point Likert scale, with each item scored from 0 to 3. The total score ranges from 0 to 60 points. The higher the score, the stronger the depressive symptoms.

  Change from Baseline CES-D at 5 weeks

Secondary Outcomes (2)

• Psychological distress as measured by the Kessler Screening Scale for Psychological Distress (K6) score.

  Change from Baseline K6 at 5 weeks

• Anxiety as measured by the 7-item Generalized Anxiety Disorder Scale (GAD-7).

  Change from Baseline GAD-7 at 5 weeks

Study Arms (2)

Smartphone Application

EXPERIMENTAL

Participants watch a video using the Smartphone Application displaying positive word stimuli.

Device: Smartphone Application

No Intervention

NO INTERVENTION

No Intervention.

Interventions

Smartphone Application DEVICE

The experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks.

Smartphone Application

Eligibility Criteria

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

You may qualify if:

• Years and older
• Males and females
• Center for Epidemiologic Studies Depression Scale score ≥16
• Written informed consent prior to participation
• Owns a smartphone with the iOS® operating system

You may not qualify if:

• Lifetime history of psychiatric disorders
• Currently receiving treatment for a mental health problem from a mental health professional
• Experience of a major depressive episode in the 2 weeks prior to the study, as ascertained using the Mini-International Neuropsychiatric Interview
• Vision or hearing deficits that negatively impact everyday life

Sponsors & Collaborators

• Kibi International University: lead

Study Sites (1)

Kibi International University

Takahashi, Okayama-ken, 716-8508, Japan

Location

Related Publications (1)

• Kato Y, Kageyama K, Mesaki T, Uchida H, Sejima Y, Marume R, Takahashi K, Hirao K. Study protocol for a pilot randomized controlled trial on a smartphone application-based intervention for subthreshold depression: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Jan;99(4):e18934. doi: 10.1097/MD.0000000000018934.

  PMID: 31977910 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 23, 2019
• Study Start: October 29, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)