Testing TRUST Depression Management Intervention

Quality of Life Clinical Trial

— TRUST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599141
• Other study ID #: 20180519
• Secondary ID: U54MD002265-11
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2023
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Quality of Life

Intervention

Behavioral:
• Trust-building Self-management Together
Trust building plus depression self-management
• Depression Management
Traditional depression self-management

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-8 Adolescent	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).	3 months and 6 months post baseline
Secondary	Youth Quality of Life Scale	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).	3 and 6 months post baseline
Secondary	Adolescent Sleep Hygiene Scale	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 and 6 months post baseline
Secondary	Stress Management	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).	3 and 6 months post baseline
Secondary	Medication Adherence	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).	3 and 6 months post baseline
Secondary	Appointment Keeping	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).	3 and 6 months post baseline