DepressionNCT02429674
The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances
A study testing TranS-C and IPT-A in people with Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents (IPT-A) with depression works to change sleep and related biological markers found in saliva, namely cortisol and pro-inflammatory cytokine levels. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- TranS-C and IPT-A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- outpatient participant
- parent or legally authorized representative must provide consent and assent by the participant
- Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) criteria for a depressive disorder
- Clinical Global Assessment Scale (C-GAS) < 65
- Quick Inventory of Depression Symptoms - Self Report 16 (QIDS-SR16) over 8 and less than 24.
- English speaking
- significant sleep complaints
Who cannot join
- co-morbid psychiatric diagnosis of bipolar disorder, psychosis, autism spectrum disorder, intellectual development disorder, conduct disorder or substance abuse disorder
- any condition or illness such as uncontrolled seizure disorder, uncontrolled diabetes, or any other conditions that represent as an inappropriate risk to the participant and/or could confound the interpretation of the study
- currently in active evidence-based psychotherapy for the same condition
- currently taking medication for a psychiatric diagnosis that is not a stable dose (4 weeks on the same dose).
- currently considered at risk for suicide in the opinion of the study doctor, has made a suicide attempt in the past 4 months, or is currently reporting active suicidal ideation.
- history of alcohol or other substance abuse as defined by DSM-V within the last 6 months.
- evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep
- sleep treatment that might confound the interpretation of sleep outcomes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Anxiety and Mood Research Clinic, New York State Psychiatric Institute
New York, New York, 10032
About this study
The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents (IPT-A) with depression works to change sleep and related biological markers found in saliva, namely cortisol and pro-inflammatory cytokine levels. The long-term goal of this project is to understand the biological mechanisms of recovery from depression in order to assist in selecting and guiding personalized psychotherapeutic interventions with the highest likelihood of success for individual adolescents with depression.
Read the detailed description
The primary aim of this project is to examine whether adolescent depression and the associated symptoms of sleep disturbance are best treated using an empirically supported psychotherapy that is augmented with a sleep improvement module. Twenty adolescents (ages 12-17) who meet criteria for major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood and also report elevated levels of sleep disturbance will receive Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) with an adjunctive sleep module that is integrated throughout the treatment. Identifying the best approach to treating both the adolescent's depression and the commonly associated symptom of sleep disturbance will have significant implications for the long-term outcomes of depressed adolescents. Moreover, identifying unique symptom and biological profiles at the outset of treatment may enable doctors to predict treatment outcome.
- Conditions
- Depression
- Being tested
- TranS-C and IPT-A
- Keywords
- Depression, Adolescence
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranS-C and IPT-ABehavioural
Also called Transdiagnostic Sleep and Circadian treatment and IPT-A
The goal of IPT-A is to decrease depressive symptoms by focusing on current interpersonal difficulties and helping the adolescent improve his or her relationships and interpersonal interactions. This is accomplished through psychoeducation about the adolescent's depression and its link to interpersonal relationships, review of the adolescent's significant relationships, identification of interpersonal problem areas on which to focus the treatment, development of interpersonal problem solving and communication skills, and role-playing. The sleep disturbances intervention will include several modules selected because they are successful treatments for insomnia, and/or may help promote adherence to some of the recommendations related to sleep.
| Study group | Role | What they receive |
|---|---|---|
| TranS-C and IPT-A | Other | 12 sessions of weekly outpatient psychotherapy for adolescent depression. Receives: Behavioral: TranS-C and IPT-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Depression symptom score on the Children's Depression Rating Scale (CDRS)
Reduction in depression symptoms
Measured: Week 12
Secondary outcomes (2)
Change from Baseline in sleep using actigraphy estimated sleep variables
Reduction in sleep difficulties and increase in sleep duration
Measured: Week 12
Change from baseline in Cytokine levels found in saliva
Reduction in inflammatory markers
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleanor McGlinchey, New York State Psychiatric Institute
- Investigators
- Eleanor L McGlinchey, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429674
- Sponsor's protocol ID
- #7089
- Status last verified
- Jan 2021
- First submitted
- 22 Apr 2015
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Depression Intervention for Adolescents With Depression and Sleep Disturbances
- ClinicalTrials.gov ID
- NCT02429674
- Acronym / sponsor ID
- #7089
- Conditions
- Depression
- Keywords
- Depression, Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The focus of this study is on identifying how Interpersonal Psychotherapy for Adolescents (IPT-A) with depression works to change sleep and related biological markers found in saliva, namely cortisol and pro-inflammatory cytokine levels. The long-term goal of this project is to understand the biological mechanisms of recovery from depression in order to assist in selecting and guiding personalized psychotherapeutic interventions with the highest likelihood of success for individual adolescents with depression.
Detailed description
The primary aim of this project is to examine whether adolescent depression and the associated symptoms of sleep disturbance are best treated using an empirically supported psychotherapy that is augmented with a sleep improvement module. Twenty adolescents (ages 12-17) who meet criteria for major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood and also report elevated levels of sleep disturbance will receive Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) with an adjunctive sleep module that is integrated throughout the treatment. Identifying the best approach to treating both the adolescent's depression and the commonly associated symptom of sleep disturbance will have significant implications for the long-term outcomes of depressed adolescents. Moreover, identifying unique symptom and biological profiles at the outset of treatment may enable doctors to predict treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TranS-C and IPT-A | Other | Behavioral: TranS-C and IPT-A12 sessions of weekly outpatient psychotherapy for adolescent depression. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- outpatient participant
- parent or legally authorized representative must provide consent and assent by the participant
- Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) criteria for a depressive disorder
- Clinical Global Assessment Scale (C-GAS) < 65
- Quick Inventory of Depression Symptoms - Self Report 16 (QIDS-SR16) over 8 and less than 24.
Key exclusion criteria (8 listed)
- co-morbid psychiatric diagnosis of bipolar disorder, psychosis, autism spectrum disorder, intellectual development disorder, conduct disorder or substance abuse disorder
- any condition or illness such as uncontrolled seizure disorder, uncontrolled diabetes, or any other conditions that represent as an inappropriate risk to the participant and/or could confound the interpretation of the study
- currently in active evidence-based psychotherapy for the same condition
- currently taking medication for a psychiatric diagnosis that is not a stable dose (4 weeks on the same dose).
- currently considered at risk for suicide in the opinion of the study doctor, has made a suicide attempt in the past 4 months, or is currently reporting active suicidal ideation.
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 |
|---|---|---|
| TranS-C and IPT-AAlso: Transdiagnostic Sleep and Circadian treatment and IPT-AThe goal of IPT-A is to decrease depressive symptoms by focusing on current interpersonal difficulties and helping the adolescent improve his or her relationships and interpersonal interactions. This is accomplished through psychoeducation about the adolescent's depression and its link to interpersonal relationships, review of the adolescent's significant relationships, identification of interpersonal problem areas on which to focus the treatment, development of interpersonal problem solving and communication skills, and role-playing. The sleep disturbances intervention will include several modules selected because they are successful treatments for insomnia, and/or may help promote adherence to some of the recommendations related to sleep. | Behavioural | TranS-C and IPT-A |
Primary outcome
Change from Baseline in Depression symptom score on the Children's Depression Rating Scale (CDRS)
Time frame: Week 12
Reduction in depression symptoms
2 secondary outcomes
Change from Baseline in sleep using actigraphy estimated sleep variables
Time frame: Week 12
Change from baseline in Cytokine levels found in saliva
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Eleanor L McGlinchey, Ph.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TranS-C and IPT-A in people with Depression, run by New York State Psychiatric Institute 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 7 inclusion and 8 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 1 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Depression symptom score on the Children's Depression Rating Scale (CDRS) (time frame: Week 12). 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 1 Feb 2021.