Testing TRUST Depression Management Intervention

NCT03599141 | Completed Results DMC

• 2 other identifiers: 20180519U54MD002265-11
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Symptoms; Quality of Life

Keywords

adolescent; parent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Youth Quality of Life Scale

  3 and 6 months post baseline

• Adolescent Sleep Hygiene Scale

  3 and 6 months post baseline

• Stress Management

  3 and 6 months post baseline

• Medication Adherence

  3 and 6 months post baseline

• Appointment Keeping

  3 and 6 months post baseline

Study Arms (2)

Depression Management

ACTIVE COMPARATOR

8 weekly group sessions

Behavioral: Depression Management

Trust-building Self-management Together

EXPERIMENTAL

8 weekly group sessions

Behavioral: Trust-building Self-management Together

Interventions

Trust-building Self-management Together BEHAVIORAL

Trust building plus depression self-management

Trust-building Self-management Together

Depression Management BEHAVIORAL

Traditional depression self-management

Depression Management

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

This is a small feasibility study; therefore, these results may not be generalizable.

Results Point of Contact

• Title: Heather K. Hardin
• Organization: Indiana University

hhardin@iu.edu

317.274.5966

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 26, 2018
• Study Start: October 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: November 30, 2022
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)