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Testing TRUST Depression Management Intervention

Sponsor
Case Western Reserve University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03599141
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
30
Enrollment
1
Location
2
Arms
54.9
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the effectiveness of a novel depression management intervention in adolescents with depression. Half of participants will receive a traditional depression management intervention, wile the other half will receive the novel depression management intervention.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Trust-building Self-management Together
  • Behavioral: Depression Management
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient Health Questionnaire-9 (PHQ-9) [Depressive symptoms] [From Baseline to 3 months and 6 months]

      Change in total summed score on PHQ-9. Higher scores indicate greater depressive symptoms. Range is 0-27.

    Secondary Outcome Measures

    1. Youth Quality of Life scale [From Baseline to 3 monhts and 6 months]

      Change in total summed and transformed score on the Youth Quality of Life scale. The response scale ranges from 0 = not at all to 10 = a great deal or completely. The scores are summed and then transformed to a 0 to 100 scale, with a higher score representing a higher quality of life.

    2. Adolescent Sleep Hygiene Scale [From Baseline to 3 months and 6 months]

      Change in mean score of all items in each subscale of the Adolescent Sleep Hygiene Scale. Higher scores indicate better sleep hygiene. Range is 1-6.

    3. Adolescent Lifestyle Questionnaire Stress management subscale [From Baseline to 3 months and 6 months]

      Change in total summed score on stress management sub-scale of the Adolescent Lifestyle Questionnaire. Higher scores indicate better stress management. Range is 4-20.

    4. Extent of Medication Non-Adherence scale (Medication adherence) [From Baseline to 3 months and 6 months]

      Change in total summed score on the Extent of Medication Non-Adherence scale. Higher scores indicate greater levels of nonadherence. Range is 3-15.

    5. Hill-Bone Compliance Scale (Appointment keeping) [From Baseline to 3 months and 6 months]

      Change in total summed score on Hill-Bone Compliance Scale. Range is 9-36, with lower scores indicating greater appointment keeping.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Case Western Reserve University Cleveland Ohio United States 44106

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heather K. Hardin, PhD, RN, Assistant Professor, Case Western Reserve University
    ClinicalTrials.gov Identifier:
    NCT03599141
    Other Study ID Numbers:
    • 20180519
    • U54MD002265-11
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Heather K. Hardin, PhD, RN, Assistant Professor, Case Western Reserve University
    adolescent
    parent
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Feb 10, 2022