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Completed

NCT Number: NCT03110016

Smartphone Intervention for Subthreshold Depression

The study aimed to examine the feasibility, usability, user satisfaction, safety, and preliminary efficacy of a smartphone application intervention for young adults with subthreshold depression.

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Key information

Conditions

Subthreshold Depression

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kibi International University

Takahashi, Okayama-ken, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-24 years
  • Has a Center for Epidemiologic Studies Depression Scale score of ≥16
  • Owns a smartphone with the iOS® operating system

Exclusion criteria

  • Lifetime history of major depressive disorder
  • Lifetime history of bipolar disorder
  • 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

Treatment and study plan

Smartphone application

Device

The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.

Primary outcomes

  1. Feasibility, as measured by adherence to the smartphone application intervention.

    Time frame: 5 weeks after initiating the intervention

    Adherence is calculated as the number of minutes in a week for which the participant uses the SPSRS application divided by the recommended weekly duration (70 min).

Secondary outcomes

  1. Usability and user satisfaction

    Time frame: 5 weeks after initiating the intervention

    USE Questionnaire

  2. Number of participants with treatment-related adverse events as assessed by Mini-International Neuropsychiatric Interview.

    Time frame: baseline and 1, 2, 3, 4, and 5 weeks after initiating the intervention

    Mini-International Neuropsychiatric Interview

  3. Depressive symptoms

    Time frame: baseline and 5 weeks after initiating the intervention

    Center for Epidemiologic Studies Depression Scale score

  4. Inflammatory biomarker

    Time frame: baseline and 5 weeks after initiating the intervention

    Level of salivary interleukin-6

  5. General self-efficacy

    Time frame: baseline and 5 weeks after initiating the intervention

    General Self-Efficacy Scale score

  6. Social anxiety

    Time frame: baseline and 5 weeks after initiating the intervention

    Liebowitz Social Anxiety Scale score

  7. Mental health

    Time frame: baseline and 5 weeks after initiating the intervention

    12-item General Health Questionnaire score

Sponsors and collaborators

Lead sponsor

Kibi International University

Other

Registry information

Official study title

Feasibility, Usability, User Satisfaction, and Preliminary Efficacy of a Smartphone Intervention for Subthreshold Depression

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2017
Registry last updated
Jul 28, 2017

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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