Testing TRUST Depression Management Intervention

Not Applicable

Completed

• Conditions: Depressive Symptoms; Quality of Life
• Interventions: Behavioral: Trust-building Self-management Together; Behavioral: Depression Management

• Registration Number: NCT03599141
• Lead Sponsor: Case Western Reserve University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Study Start: 2018-10-01
• Primary Completion: 2021-09-30
• Study Completion: 2022-11-30
• Results First Submitted: 2023-08-31
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Results First Posted: 2024-01-09
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trust-building Self-management Together	Trust-building Self-management Together	8 weekly group sessions
Depression Management	Depression Management	8 weekly group sessions

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-8 Adolescent	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 Outcome Measures

Name	Time	Method
Appointment Keeping	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).
Stress Management	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).
Medication Adherence	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).
Adolescent Sleep Hygiene Scale	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.
Youth Quality of Life Scale	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).

Trial Locations

Locations (1)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States