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Completed

NCT Number: NCT04136041

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

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.

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Key information

Conditions

Subthreshold Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kibi International University

Takahashi, Okayama-ken, 716-8508, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

Smartphone application

Device

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

Primary outcomes

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

    Time frame: Change from Baseline CES-D at 5 weeks

    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.

Secondary outcomes

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

    Time frame: Change from Baseline K6 at 5 weeks

    The K6 is a 6-item self-report questionnaire used to measure psychological distress. The K6 is a five-point Likert scale, with each item scored from 0 to 4. The total score ranges from 0 to 24 points. The higher the score, the stronger the psychological distress.

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

    Time frame: Change from Baseline GAD-7 at 5 weeks

    The GAD-7 is a 7-item self-report questionnaire used to measure anxiety. The GAD-7 is a four-point Likert scale, with each item scored from 0 to 3. The total score ranges from 0 to 21 points. The higher the score, the stronger the anxiety.

Sponsors and collaborators

Lead sponsor

Kibi International University

Other

Registry information

Official study title

Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2019
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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