NCT03599141: TRUST

Testing TRUST Depression Management Intervention

Completed NA Results posted Last updated 9 January 2024

What this trial tests

NA trial testing Trust-building Self-management Together in Depressive Symptoms in 16 participants. Completed in 30 November 2022.

Timeline

1 October 2018

Primary endpoint
30 September 2021

30 November 2022

Quick facts

Lead sponsor	Case Western Reserve University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	16
Start date	1 October 2018
Primary completion	30 September 2021
Estimated completion	30 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Trust-building Self-management Together
• Depression Management

Conditions studied

• Depressive Symptoms — all drugs for Depressive Symptoms →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Case Western Reserve University

Who can join

Adults 14 to 17, any sex, with Depressive Symptoms or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Health Questionnaire-8 Adolescent Primary · 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).

3 months post baseline

Group	Value	95% CI
Depression Management	6.17	± 1.33
Trust-building Self-management Together	9.43	± 6.32

6 months post baseline

Group	Value	95% CI
Depression Management	6.80	± 1.92
Trust-building Self-management Together	8.29	± 6.40

Youth Quality of Life Scale Secondary · 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).

3 months post baseline

Group	Value	95% CI
Depression Management	71.89	± 18.32
Trust-building Self-management Together	57.33	± 16.17

6 months post baseline

Group	Value	95% CI
Depression Management	64.93	± 17.10
Trust-building Self-management Together	61.71	± 13.47

Adolescent Sleep Hygiene Scale Secondary · 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.

3 months post baseline

Group	Value	95% CI
Depression Management	4.63	± 0.62
Trust-building Self-management Together	4.56	± 0.31

6 months post baseline

Group	Value	95% CI
Depression Management	4.73	± 0.47
Trust-building Self-management Together	4.17	± 0.34

Stress Management Secondary · 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).

3 months post baseline

Group	Value	95% CI
Depression Management	14.33	± 2.07
Trust-building Self-management Together	9.86	± 1.57

6 months post baseline

Group	Value	95% CI
Depression Management	13.40	± 2.41
Trust-building Self-management Together	12.43	± 2.15

Medication Adherence Secondary · 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).

3 months post baseline

Group	Value	95% CI
Depression Management	2.33	± 1.76
Trust-building Self-management Together	4.67	± 0.58

6 months post baseline

Group	Value	95% CI
Depression Management	2.08	± 1.26
Trust-building Self-management Together	4.00	± 1.41

Appointment Keeping Secondary · 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).

3 months post baseline

Group	Value	95% CI
Depression Management	7.40	± 1.95
Trust-building Self-management Together	8.67	± 1.53

6 months post baseline

Group	Value	95% CI
Depression Management	7.20	± 3.27
Trust-building Self-management Together	5.83	± 2.86

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.