Depressive SymptomsTRUSTNCT03599141
Testing TRUST Depression Management Intervention
A study testing Trust-building Self-management Together and Depression Management in people with Depressive Symptoms and Quality of Life, run by Case Western Reserve University at 1 site in United States.
Trial summary
This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Quality of Life
- What is being tested?
- Trust-building Self-management Together and Depression Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Lives in the Cleveland metro area
- Ages 14-17 years old
- Reports moderate depressive symptoms
- Able to read, speak, and understand the English language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents
This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression.
Read the detailed description
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
- Depressive Symptoms, Quality of Life
- Being tested
- Trust-building Self-management Together, Depression Management
- Keywords
- adolescent, parent
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trust-building Self-management TogetherBehavioural
Trust building plus depression self-management
Depression ManagementBehavioural
Traditional depression self-management
| Study group | Role | What they receive |
|---|---|---|
| Depression Management | Active comparator | 8 weekly group sessions Receives: Behavioral: Depression Management |
| Trust-building Self-management Together | Experimental | 8 weekly group sessions Receives: Behavioral: Trust-building Self-management Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-8 Adolescent
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).
Measured: 3 months and 6 months post baseline
Secondary outcomes (5)
Youth Quality of Life Scale
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).
Measured: 3 and 6 months post baseline
Adolescent Sleep Hygiene Scale
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.
Measured: 3 and 6 months post baseline
Stress Management
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).
Measured: 3 and 6 months post baseline
Medication Adherence
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).
Measured: 3 and 6 months post baseline
Appointment Keeping
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).
Measured: 3 and 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Heather K. Hardin, PhD, RN, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599141
- Sponsor's protocol ID
- 20180519
- Other IDs
- U54MD002265-11
- Acronym
- TRUST
- Status last verified
- Dec 2023
- First submitted
- 5 Jun 2018
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared for further analysis after main results are published.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT to Evaluate the Effects of a Trust-Building Depression Management Intervention on Moderate Depressive Symptoms in Low-Income Adolescents
- ClinicalTrials.gov ID
- NCT03599141
- Acronym / sponsor ID
- TRUST / 20180519
- Conditions
- Depressive Symptoms, Quality of Life
- Keywords
- adolescent, parent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 9 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness of a novel depression self-management intervention in adolescents with depression.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression Management | Active comparator | Behavioral: Depression Management8 weekly group sessions |
| Trust-building Self-management Together | Experimental | Behavioral: Trust-building Self-management Together8 weekly group sessions |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Lives in the Cleveland metro area
- Ages 14-17 years old
- Reports moderate depressive symptoms
- Able to read, speak, and understand the English language
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trust-building Self-management TogetherTrust building plus depression self-management | Behavioural | Trust-building Self-management Together |
| Depression ManagementTraditional depression self-management | Behavioural | Depression Management |
Primary outcome
Patient Health Questionnaire-8 Adolescent
Time frame: 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).
5 secondary outcomes
Youth Quality of Life Scale
Time frame: 3 and 6 months post baseline
Adolescent Sleep Hygiene Scale
Time frame: 3 and 6 months post baseline
Stress Management
Time frame: 3 and 6 months post baseline
Medication Adherence
Time frame: 3 and 6 months post baseline
Appointment Keeping
Time frame: 3 and 6 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be shared for further analysis after main results are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trust-building Self-management Together and Depression Management in people with Depressive Symptoms and Quality of Life, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-8 Adolescent (time frame: 3 months and 6 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.