Testing TRUST Depression Management Intervention (TRUST)

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Depressive Symptoms
• Intervention / Treatment: Behavioral: Depression Management; Behavioral: Trust-building Self-management Together

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather K Hardin, PhD; Phone Number: 216.368.5129; Email: hkh10@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Depression Management; 8 weekly group sessions	Behavioral: Depression Management; Traditional depression self-management; Other Names: DM
Experimental: Trust-building Self-management Together; 8 weekly group sessions	Behavioral: Trust-building Self-management Together; Trust building plus depression self-management; Other Names: TRUST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: adolescent; parent
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 20180519; U54MD002265-11 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared for further analysis after main results are published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No