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Completed

NCT Number: NCT03599141

Testing TRUST Depression Management Intervention

This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression Quality of Life

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

About this study

Half of participants will receive a traditional depression self-management intervention, while the other half will receive the novel depression self-management intervention. In an exploratory, pilot 2-group randomized controlled trial (RCT), 16 adolescents were followed over 6 months. Data were collected at baseline, 3 months, and 6 months.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Lives in the Cleveland metro area
  • Ages 14-17 years old
  • Reports moderate depressive symptoms
  • Able to read, speak, and understand the English language

Exclusion criteria

  • Current suicide risk
  • Diagnosis with bipolar disorder, schizophrenia, or a personality disorder
  • Severe behavioral problems that preclude group participation (as reported by parent)
  • Family plans to move from the region within 6 months

Treatment and study plan

Trust-building Self-management Together

Behavioral

Trust building plus depression self-management

Depression Management

Behavioral

Traditional depression self-management

Primary outcomes

  1. Patient Health Questionnaire-8 Adolescent

    Time frame: 3 months and 6 months post baseline

    The Patient Health Questionnaire-8 (PHQ-8) Adolescent has 8 items scored on a 4 point Likert scale summed for a total score ranging from 0-24. Higher scores indicate greater levels of depressive symptoms with a score of 10 indicating a moderate level of depressive symptoms. The population mean = 5.6 (SD = 1.0).

Secondary outcomes

  1. Youth Quality of Life Scale

    Time frame: 3 and 6 months post baseline

    The Youth Quality of Life Instrument-Short Form has 15 items measured on a 10 point Likert scale that are summed and t-scored, with higher scores indicating greater QoL. This is a continuously distributed scale without clinical cutoff scores. The quality of life mean t-score in the youth without depression (M= 81.0, SD= 11.7) is greater than the mean t-score in youth diagnosed with depression (M= 58.6, SD= 14.2).

  2. Adolescent Sleep Hygiene Scale

    Time frame: 3 and 6 months post baseline

    The Adolescent Sleep Hygiene Scale-revised has 8 subscales with 24 items scored on a 6 point Likert scale. Each subscale total is the mean of the items contained within. The mean of the subscale scores indicates the overall sleep score, with higher scores indicating greater sleep hygiene. The range is 1-6, with poor sleep hygiene indicated by the lowest quintile scores, which is ≤ 3.8 and good sleep hygiene is indicated by the highest quintile score, which is ≥ 4.9.

  3. Stress Management

    Time frame: 3 and 6 months post baseline

    The Adolescent Lifestyle Questionnaire Stress Management Subscale has four items on a 5 point Likert scale that are summed for a total score. The range is 5-20. Higher scores indicate greater stress management behavior. This is a continuously distributed scale without clinical cutoff scores. The population mean = 13.0 (SD = 3.6).

  4. Medication Adherence

    Time frame: 3 and 6 months post baseline

    The Extent of Non-Adherence Scale has 3 items measured on a 5-point Likert scale. A total score reflecting non-adherence is calculated by the mean of item responses, with a range of 1-5. Higher scores indicate greater levels of non-adherence and lower scores indicate greater adherence. The population mean = 1.8 (SD = 1.0).

  5. Appointment Keeping

    Time frame: 3 and 6 months post baseline

    The Hill-Bone Compliance Appointment Keeping Scale has 3 items measured on a four-point Likert scale. One item is reverse scored and then the three items are summed, resulting in a score ranging from 3-12. This is a continuously distributed scale without clinical cutoff scores. Lower scores indicate greater appointment keeping (M = 5.27 ± 0.93).

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents

Acronym: TRUST

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 26, 2018
Registry last updated
Jan 9, 2024

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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