Testing TRUST Depression Management Intervention

NCT ID: NCT03599141

Last Updated: 2024-01-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Depressive Symptoms Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Depression Management

8 weekly group sessions

Group Type ACTIVE_COMPARATOR

Depression Management

Intervention Type BEHAVIORAL

Traditional depression self-management

Trust-building Self-management Together

8 weekly group sessions

Group Type EXPERIMENTAL

Trust-building Self-management Together

Intervention Type BEHAVIORAL

Trust building plus depression self-management

Interventions

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Trust-building Self-management Together

Trust building plus depression self-management

Intervention Type BEHAVIORAL

Depression Management

Traditional depression self-management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role lead

Responsible Party

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Heather K. Hardin, PhD, RN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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U54MD002265-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20180519

Identifier Type: -

Identifier Source: org_study_id

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