Testing TRUST Depression Management Intervention (TRUST)
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|ClinicalTrials.gov Identifier: NCT03599141|
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression Quality of Life||Behavioral: Trust-building Self-management Together Behavioral: Depression Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||October 1, 2018|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Active Comparator: Depression Management
8 weekly group sessions
Behavioral: Depression Management
Traditional depression self-management
Other Name: DM
Experimental: Trust-building Self-management Together
8 weekly group sessions
Behavioral: Trust-building Self-management Together
Trust building plus depression self-management
Other Name: TRUST
- Patient Health Questionnaire-9 (PHQ-9) [Depressive symptoms] [ Time Frame: 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.
- Youth Quality of Life scale [ Time Frame: 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.
- Adolescent Sleep Hygiene Scale [ Time Frame: 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.
- Adolescent Lifestyle Questionnaire Stress management subscale [ Time Frame: 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.
- Extent of Medication Non-Adherence scale (Medication adherence) [ Time Frame: 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.
- Hill-Bone Compliance Scale (Appointment keeping) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599141
|Contact: Heather K Hardin, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Heather K Hardin 216-368-5129 email@example.com|
|Principal Investigator: Heather K Hardin, PhD|