Trial Outcomes & Findings for Testing TRUST Depression Management Intervention (NCT NCT03599141)

NCT ID: NCT03599141

Last Updated: 2024-01-09

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 3 months and 6 months post baseline
• Results posted on: 2024-01-09

Participant Flow

We recruited in the community using flyers in Cleveland, Ohio from 2018-2020.

All consented participants were assigned arms.

Participant milestones

Measure	Depression Management 8 weekly group sessions Depression Management: Traditional depression self-management	Trust-building Self-management Together 8 weekly group sessions Trust-building Self-management Together: Trust building plus depression self-management
Overall Study STARTED	8	8
Overall Study 3 Months Post Baseline	8	8
Overall Study 6 Months Post Baseline	5	7
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Depression Management 8 weekly group sessions Depression Management: Traditional depression self-management	Trust-building Self-management Together 8 weekly group sessions Trust-building Self-management Together: Trust building plus depression self-management
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

Testing TRUST Depression Management Intervention

Baseline characteristics by cohort

Measure	Depression Management n=8 Participants 8 weekly group sessions Depression Management: Traditional depression self-management	Trust-building Self-management Together n=8 Participants 8 weekly group sessions Trust-building Self-management Together: Trust building plus depression self-management	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.75 years STANDARD_DEVIATION 0.31 • n=5 Participants	15.13 years STANDARD_DEVIATION 0.35 • n=7 Participants	14.94 years STANDARD_DEVIATION 0.23 • n=5 Participants
Sex/Gender, Customized Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex/Gender, Customized Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex/Gender, Customized Transgender; Other, not specified	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Depressive Symptoms	13.75 units on a scale STANDARD_DEVIATION 4.03 • n=5 Participants	12.63 units on a scale STANDARD_DEVIATION 2.07 • n=7 Participants	13.19 units on a scale STANDARD_DEVIATION 3.15 • n=5 Participants
Quality of Life	54.75 T-score STANDARD_DEVIATION 11.70 • n=5 Participants	58.33 T-score STANDARD_DEVIATION 13.59 • n=7 Participants	56.54 T-score STANDARD_DEVIATION 12.39 • n=5 Participants
Sleep	4.22 units on a scale STANDARD_DEVIATION 0.85 • n=5 Participants	4.19 units on a scale STANDARD_DEVIATION 0.52 • n=7 Participants	4.20 units on a scale STANDARD_DEVIATION 0.67 • n=5 Participants
Stress management	11.00 units on a scale STANDARD_DEVIATION 4.28 • n=5 Participants	10.50 units on a scale STANDARD_DEVIATION 2.93 • n=7 Participants	10.73 units on a scale STANDARD_DEVIATION 3.49 • n=5 Participants
Medication adherence	2.08 units on a scale STANDARD_DEVIATION 1.20 • n=5 Participants	2.66 units on a scale STANDARD_DEVIATION 0.33 • n=7 Participants	2.33 units on a scale STANDARD_DEVIATION 0.92 • n=5 Participants
Appointment keeping	5.40 units on a scale STANDARD_DEVIATION 1.81 • n=5 Participants	6.20 units on a scale STANDARD_DEVIATION 2.95 • n=7 Participants	5.80 units on a scale STANDARD_DEVIATION 2.35 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months and 6 months post baseline

Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 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).

Outcome measures

Measure	Depression Management n=8 Participants 8 weekly group sessions with self-management content	Trust-building Self-management Together n=8 Participants 8 weekly group sessions with self-management content and parent relationship building content
Patient Health Questionnaire-8 Adolescent 3 months post baseline	6.17 units on a scale Standard Deviation 1.33	9.43 units on a scale Standard Deviation 6.32
Patient Health Questionnaire-8 Adolescent 6 months post baseline	6.80 units on a scale Standard Deviation 1.92	8.29 units on a scale Standard Deviation 6.40

SECONDARY outcome

Timeframe: 3 and 6 months post baseline

Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 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).

Outcome measures

Measure	Depression Management n=8 Participants 8 weekly group sessions with self-management content	Trust-building Self-management Together n=8 Participants 8 weekly group sessions with self-management content and parent relationship building content
Youth Quality of Life Scale 3 months post baseline	71.89 units on a scale Standard Deviation 18.32	57.33 units on a scale Standard Deviation 16.17
Youth Quality of Life Scale 6 months post baseline	64.93 units on a scale Standard Deviation 17.10	61.71 units on a scale Standard Deviation 13.47

SECONDARY outcome

Timeframe: 3 and 6 months post baseline

Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 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.

Outcome measures

Measure	Depression Management n=8 Participants 8 weekly group sessions with self-management content	Trust-building Self-management Together n=8 Participants 8 weekly group sessions with self-management content and parent relationship building content
Adolescent Sleep Hygiene Scale 3 months post baseline	4.63 units on a scale Standard Deviation 0.62	4.56 units on a scale Standard Deviation 0.31
Adolescent Sleep Hygiene Scale 6 months post baseline	4.73 units on a scale Standard Deviation 0.47	4.17 units on a scale Standard Deviation 0.34

SECONDARY outcome

Timeframe: 3 and 6 months post baseline

Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 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).

Outcome measures

Measure	Depression Management n=8 Participants 8 weekly group sessions with self-management content	Trust-building Self-management Together n=8 Participants 8 weekly group sessions with self-management content and parent relationship building content
Stress Management 3 months post baseline	14.33 units on a scale Standard Deviation 2.07	9.86 units on a scale Standard Deviation 1.57
Stress Management 6 months post baseline	13.40 units on a scale Standard Deviation 2.41	12.43 units on a scale Standard Deviation 2.15

SECONDARY outcome

Timeframe: 3 and 6 months post baseline

Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 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).

Outcome measures

Measure	Depression Management n=8 Participants 8 weekly group sessions with self-management content	Trust-building Self-management Together n=8 Participants 8 weekly group sessions with self-management content and parent relationship building content
Medication Adherence 3 months post baseline	2.33 units on a scale Standard Deviation 1.76	4.67 units on a scale Standard Deviation 0.58
Medication Adherence 6 months post baseline	2.08 units on a scale Standard Deviation 1.26	4.00 units on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: 3 and 6 months post baseline

Population: Using intent-to-treat principles, all participants were included in the analysis. However, four participants were lost to follow up at 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).

Outcome measures

Measure	Depression Management n=8 Participants 8 weekly group sessions with self-management content	Trust-building Self-management Together n=8 Participants 8 weekly group sessions with self-management content and parent relationship building content
Appointment Keeping 3 months post baseline	7.40 units on a scale Standard Deviation 1.95	8.67 units on a scale Standard Deviation 1.53
Appointment Keeping 6 months post baseline	7.20 units on a scale Standard Deviation 3.27	5.83 units on a scale Standard Deviation 2.86

Adverse Events

Depression Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Trust-building Self-management Together

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather K. Hardin

Indiana University

Phone: 317.274.5966

Email: hhardin@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place