Depressive SymptomsSAMNCT04109716
School Adolescent Mood Project: Efficacy of IPT-AST in Schools
A study testing Interpersonal Psychotherapy - Adolescent Skills Training and Services as usual in people with Depressive Symptoms, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This school-based randomized controlled trial will: a) examine the effects of telehealth-administered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program, as compared to services as usual (SAU) on social processes and emotional and school outcomes, b)… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Interpersonal Psychotherapy - Adolescent Skills Training and Services as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 2 Dec 2024
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescents in 9th or 10th grade between the ages of 14 and 17
- Adolescent must be English-speaking; parents must be English or Spanish-speaking
- Parental/guardian permission (informed consent) and child assent/consent
- A score of 16 or higher on the CES-D AND at least 2 threshold or subthreshold symptoms on the K-SADS-PL
- Have access to a cellular phone, computer, and/or tablet and have internet access to complete the remote intervention and evaluations
- Parents of students in 9th or 10th grade between the ages of 14 and 17 at one of the participating schools
Show all 20Show fewer
- English or Spanish-speaking or limited English proficiency with use of interpreter
- Consent to participate
- Have access to a phone, computer, and/or tablet to complete remote evaluations
- 18 years of age or older
- Knows the adolescent well enough to answer questions about him/her
- English or Spanish-speaking or limited English proficiency with use of interpreter
- Consent to participate
- Have access to a phone, computer, and/or tablet to complete remote evaluations
- Counselor at one of the participating high schools
- Consent to participate
- Have access to a phone, computer, and/or tablet to complete remote evaluations
- Teacher or administrator at one of the participating high schools
- Consent to participate in the qualitative interview
- Have access to a phone, computer, and/or tablet to complete remote evaluations
Who cannot join
- Less than 2 threshold or subthreshold symptoms on the K-SADS-PL
- Significant current active suicidal ideation reported on the K-SADS-PL at the eligibility evaluation or suicide attempt in the past year reported on the K-SADS-PL at the eligibility evaluation
- Significant cognitive or language impairments requiring placement in Special Education as reported by the parent or as evident in the eligibility evaluation
- Youth may be excluded on a case-by-case basis if the eligibility/baseline evaluation suggests that the group program would not be appropriate (for, instance, in the case of significant behavioral problems in the baseline evaluation).
- For Parent Participants
- None
Show all 12Show fewer
- For Parent-Designated Adult Family Member Participants (in cases where parent asks a different family member to complete parent assessments)
- None
- For Counselor Participants
- None
- For Teacher and Administrator Participants
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hopsital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
This school-based randomized controlled trial will: a) examine the effects of telehealth-administered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program, as compared to services as usual (SAU) on social processes and emotional and school outcomes, b) examine moderators and mediators of intervention effects, and c) assess the costs, cost-effectiveness, acceptability, feasibility, fidelity, and sustainability of IPT-AST.
Read the detailed description
This is a randomized clinical trial. Adolescents with elevated depressive symptoms will be identified and randomly assigned to IPT-AST delivered through telehealth by research staff (alone or in collaboration with school support staff) or services as usual (SAU) as delivered by counselors or other student support staff in schools. The research team will use longitudinal data collection with adolescents, parents, and counselors, and will collect data from teachers and school records to achieve study objectives.
Participants will be 240 racially and ethnically diverse students in the 9th and 10th grades between the ages of 14 and 17 with elevated symptoms of depression and their parents. Counselors in local high schools will also be study participants. A subset of counselors, adolescents, and administrators will also participate in a qualitative interview as part of an implementation study.
Adolescent participants will be randomly assigned to IPT-AST, an evidence-based depression prevention program, or SAU which may include supportive counseling and/or referral for services.
Standardized measures for adolescents, parents, and teachers and school records will be used to examine emotional outcomes (e.g., depression and anxiety symptoms, depression diagnoses) and school outcomes (e.g., school engagement, grades). Investigators will utilize standardized measures to assess social processes (e.g., interpersonal conflict, social functioning) that may mediate the effects of the intervention on these emotional and school outcomes. Investigators will also collect data on services received in IPT-AST and SAU, techniques utilized in both conditions, and feasibility, acceptability, fidelity, sustainability, and costs of IPT-AST using session logs, time diaries, standardized measures, leader- and consultant-rated fidelity checklists, and qualitative interviews.
- Conditions
- Depressive Symptoms
- Being tested
- Interpersonal Psychotherapy - Adolescent Skills Training, Services as usual
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy - Adolescent Skills TrainingBehavioural
This is an indicated group depression prevention consisting of 2 individual pre-group sessions, 8 weekly group session, and up to 6 individual booster sessions. IPT-AST will be delivered predominately through telehealth.
Services as usualBehavioural
Services as usual is expected to be brief periodic sessions (in person or remote) with the school counselor or services in the community.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy-Adolescent Skills Training | Experimental | Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) is an indicated group depression prevention program. In IPT-AST, adolescents learn communication (e.g., using I statements, striking while the iron is cold) and interpersonal problem-solving strategies and apply these strategies to their relationships to decrease conflict, increase social support, and improve overall social functioning. IPT-AST consists of 1 or 2 individual pre-group sessions, 1 mid-group session, 8 weekly group sessions, and up to 6 individual booster sessions. Parents are invited to attend the mid-group session so the adolescents can apply the interpersonal strategies in a conversation with a parent. The purpose of the booster sessions is to monitor symptoms and apply the interpersonal strategies to current stressors. These sessions are designed to help solidify the interpersonal skills and address current problems before they result in a worsening of symptoms. Receives: Behavioral: Interpersonal Psychotherapy - Adolescent Skills Training |
| Services as Usual (SAU) | Active comparator | Investigators anticipate that counselors in SAU will see youth in the study for brief, periodic sessions and/or will refer youth for treatment in the community. Counselors will be permitted to see the adolescents as often as they would like throughout the course of the study (up to 15-months post-baseline). Investigators will ask counselors to complete a form each time they see a teen, noting the length of the session, whether the session was scheduled or not, and the topics discussed. Receives: Behavioral: Services as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Change in depression symptoms will be measured by the Center for Epidemiologic Studies-Depression Scale (CES-D) which assesses the frequency of 20 depressive symptoms over the past week; CES-D scores range from 0 to 60 (scores of 16 or higher are considered elevated); higher scores indicate more depression symptoms
Measured: Screen, baseline, 2 month, 3 month, 9 month, 15 month
Impairment
Change in impairment will be measured by the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment
Measured: Baseline, 2 month, 3 month, 9 month, 15 month
Onset of depression diagnoses
The onset of diagnoses/change in depression diagnoses during the study period from eligibility to the 15 month assessment will be assessed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-PL)
Measured: Eligibility, 15 month
Change in academic grades
Impact of the intervention on school grades will be examined by accessing school records and looking at change in grades from baseline to the 15 month assessment.
Measured: Baseline, 15 month
Change in school attendance
Impact of the intervention on school attendance will be examined by accessing school records and looking at change in attendance from baseline through 15 months.
Measured: Baseline, 15 month
Secondary outcomes (10)
Internalizing and externalizing symptoms
Changes in internalizing and externalizing symptoms will be assessed by the Pediatric Symptom Checklist (PSC-17), which will be completed by teens, parents, and teachers; there is a total score (range of 0-34), internalizing subscale (0-24), externalizing subscale (0-20), and attention problems subscale (0-24); higher scores indicate more symptoms
Measured: Baseline, 2 month, 3 month, 9 month, 15 month
Anxiety symptoms
Change in anxiety symptoms will be assessed by the Screen for Child Anxiety Related Disorders (SCARED), a 41-item scale assessing symptoms corresponding to different anxiety disorders; we will examine total scores and the following subscales: panic, GAD, and social anxiety; total scores range from 0-82 (25 or higher indicates clinical range); panic scores range from 0-26 (7 or higher indicates clinical range); generalized anxiety disorder scores range from 0-18 (scores of 9 or higher indicates clinical range); social anxiety scale ranges from 0-14 (scores 8 or higher indicate clinical range)
Measured: Baseline, 2 month, 3 month, 9 month, 15 month
Number of disciplinary incidents
Impact of the intervention on school disciplinary incidents will be examined by accessing school records and looking at number of new disciplinary incidents from baseline to the 15 month assessment
Measured: Baseline, 15 month
School connectedness
Changes in school connectedness will be measured by the Psychological Sense of School Membership Scale, an 18 item measure of school connectedness; scores range from 18-90; higher scores indicate higher school connectedness
Measured: Baseline, 3 month, 9 month, 15 month
Emotional and behavioral engagement in learning
The short and long-term impact of the interventions on engagement in learning will be measured by change in the Engagement versus Disaffection with Learning measure, a 20-item scale that assesses emotional and behavioral engagement vs. disengagement in school; total scores range from 20 to 80; behavioral and emotional engagement scores range from 10 to 40, with higher scores indicating greater engagement
Measured: Baseline, 3 month, 9 month, 15 month
Fidelity to the intervention
The IPT-AST Fidelity Checklist will be completed by counselors and consultant to rate fidelity to IPT-AST intervention; adherence in each session is rated as a percent adherent; quality of session is also rated as percent; higher scores indicate greater adherence and quality (implementation)
Measured: Weekly during intervention delivery
Acceptability - counselors: A self-report measure, Counselor Feedback Form
A self-report measure, Counselor Feedback Form, will be completed by any counselors who co-lead IPT-AST to assess acceptability of IPT-AST following group (3 month) and booster sessions (15 month) (implementation)
Measured: 3 month, 15 month
Acceptability - adolescents: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)
A self-report measure, the Attitude Towards Intervention Questionnaire (ATI), will be completed by adolescents to assess acceptability of IPT-AST following group (3 month) and booster sessions (15 month) (implementation)
Measured: 3 month, 15 month
Patterns in qualitative data
Qualitative interviews will be conducted with IPT-AST stakeholders to gather information on implementation of IPT-AST; this is a qualitative interview which will be coded for key themes
Measured: 3 month
Attendance
Logs will track youth participation in IPT-AST and clinician attendance to IPT-AST consultation as one indicator of feasibility (implementation)
Measured: Weekly during IPT-AST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start15 Aug 2019
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences
- Responsible party
- Sponsor
- Investigators
- Jami Young, PhD, Principal investigator, CHOP, University of Pennsylvania Perelman School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109716
- Sponsor's protocol ID
- 19-016323
- Other IDs
- R305A190088
- Acronym
- SAM
- Status last verified
- Nov 2026
- First submitted
- 24 Sep 2019
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data will be entered into a de-identified electronic database and double-checked for accuracy. After data cleaning and quality assurance procedures are completed, pertinent sets of data will be converted into analytic datasets for statistical analyses. Additional variables may be derived for data analysis purposes. The cleaned, de-identified dataset, including additional derived variables, will be made accessible per IES data access requirements at the time that findings are published in a peer-reviewed journal. Data will be available for 10 years from that time.
Publications
Young JF, Jones JD, Schwartz KTG, So A, Dysart GC, Kanine RM, Gillham JE, Gallop R, Davis M. Telehealth-delivered depression prevention: Short-term outcomes from a school-based randomized controlled trial. J Consult Clin Psychol. 2025 Apr;93(4):213-225. doi: 10.1037/ccp0000913. Epub 2024 Oct 31.
PubMed 39480285
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Adolescent Mood Project: Efficacy of IPT-AST in Schools
- ClinicalTrials.gov ID
- NCT04109716
- Acronym / sponsor ID
- SAM / 19-016323
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Institute of Education Sciences
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 30 Sep 2019 (actual)
- 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.
This school-based randomized controlled trial will: a) examine the effects of telehealth-administered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program, as compared to services as usual (SAU) on social processes and emotional and school outcomes, b) examine moderators and mediators of intervention effects, and c) assess the costs, cost-effectiveness, acceptability, feasibility, fidelity, and sustainability of IPT-AST.
Detailed description
This is a randomized clinical trial. Adolescents with elevated depressive symptoms will be identified and randomly assigned to IPT-AST delivered through telehealth by research staff (alone or in collaboration with school support staff) or services as usual (SAU) as delivered by counselors or other student support staff in schools. The research team will use longitudinal data collection with adolescents, parents, and counselors, and will collect data from teachers and school records to achieve study objectives.
Participants will be 240 racially and ethnically diverse students in the 9th and 10th grades between the ages of 14 and 17 with elevated symptoms of depression and their parents. Counselors in local high schools will also be study participants. A subset of counselors, adolescents, and administrators will also participate in a qualitative interview as part of an implementation study.
Adolescent participants will be randomly assigned to IPT-AST, an evidence-based depression prevention program, or SAU which may include supportive counseling and/or referral for services.
Standardized measures for adolescents, parents, and teachers and school records will be used to examine emotional outcomes (e.g., depression and anxiety symptoms, depression diagnoses) and school outcomes (e.g., school engagement, grades). Investigators will utilize standardized measures to assess social processes (e.g., interpersonal conflict, social functioning) that may mediate the effects of the intervention on these emotional and school outcomes. Investigators will also collect data on services received in IPT-AST and SAU, techniques utilized in both conditions, and feasibility, acceptability, fidelity, sustainability, and costs of IPT-AST using session logs, time diaries, standardized measures, leader- and consultant-rated fidelity checklists, and qualitative interviews.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy-Adolescent Skills Training | Experimental | Behavioral: Interpersonal Psychotherapy - Adolescent Skills TrainingInterpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) is an indicated group depression prevention program. In IPT-AST, adolescents learn communication (e.g., using I statements, striking while the iron is cold) and interpersonal problem-solving strategies and apply these strategies to their relationships to decrease conflict, increase social support, and improve overall social functioning. IPT-AST consists of 1 or 2 individual pre-group sessions, 1 mid-group session, 8 weekly group sessions, and up to 6 individual booster sessions. Parents are invited to attend the mid-group session so the adolescents can apply the interpersonal strategies in a conversation with a parent. The purpose of the booster sessions is to monitor symptoms and apply the interpersonal strategies to current stressors. These sessions are designed to help solidify the interpersonal skills and address current problems before they result in a worsening of symptoms. |
| Services as Usual (SAU) | Active comparator | Behavioral: Services as usualInvestigators anticipate that counselors in SAU will see youth in the study for brief, periodic sessions and/or will refer youth for treatment in the community. Counselors will be permitted to see the adolescents as often as they would like throughout the course of the study (up to 15-months post-baseline). Investigators will ask counselors to complete a form each time they see a teen, noting the length of the session, whether the session was scheduled or not, and the topics discussed. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Adolescents in 9th or 10th grade between the ages of 14 and 17
- Adolescent must be English-speaking; parents must be English or Spanish-speaking
- Parental/guardian permission (informed consent) and child assent/consent
- A score of 16 or higher on the CES-D AND at least 2 threshold or subthreshold symptoms on the K-SADS-PL
- Have access to a cellular phone, computer, and/or tablet and have internet access to complete the remote intervention and evaluations
Key exclusion criteria (12 listed)
- Less than 2 threshold or subthreshold symptoms on the K-SADS-PL
- Significant current active suicidal ideation reported on the K-SADS-PL at the eligibility evaluation or suicide attempt in the past year reported on the K-SADS-PL at the eligibility evaluation
- Significant cognitive or language impairments requiring placement in Special Education as reported by the parent or as evident in the eligibility evaluation
- Youth may be excluded on a case-by-case basis if the eligibility/baseline evaluation suggests that the group program would not be appropriate (for, instance, in the case of significant behavioral problems in the baseline evaluation).
- For Parent Participants
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 |
|---|---|---|
| Interpersonal Psychotherapy - Adolescent Skills TrainingThis is an indicated group depression prevention consisting of 2 individual pre-group sessions, 8 weekly group session, and up to 6 individual booster sessions. IPT-AST will be delivered predominately through telehealth. | Behavioural | Interpersonal Psychotherapy-Adolescent Skills Training |
| Services as usualServices as usual is expected to be brief periodic sessions (in person or remote) with the school counselor or services in the community. | Behavioural | Services as Usual (SAU) |
Primary outcome
Depression symptoms
Time frame: Screen, baseline, 2 month, 3 month, 9 month, 15 month
Change in depression symptoms will be measured by the Center for Epidemiologic Studies-Depression Scale (CES-D) which assesses the frequency of 20 depressive symptoms over the past week; CES-D scores range from 0 to 60 (scores of 16 or higher are considered elevated); higher scores indicate more depression symptoms
Impairment
Time frame: Baseline, 2 month, 3 month, 9 month, 15 month
Change in impairment will be measured by the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment
Onset of depression diagnoses
Time frame: Eligibility, 15 month
The onset of diagnoses/change in depression diagnoses during the study period from eligibility to the 15 month assessment will be assessed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-PL)
Change in academic grades
Time frame: Baseline, 15 month
Impact of the intervention on school grades will be examined by accessing school records and looking at change in grades from baseline to the 15 month assessment.
Change in school attendance
Time frame: Baseline, 15 month
Impact of the intervention on school attendance will be examined by accessing school records and looking at change in attendance from baseline through 15 months.
10 secondary outcomes
Internalizing and externalizing symptoms
Time frame: Baseline, 2 month, 3 month, 9 month, 15 month
Anxiety symptoms
Time frame: Baseline, 2 month, 3 month, 9 month, 15 month
Number of disciplinary incidents
Time frame: Baseline, 15 month
School connectedness
Time frame: Baseline, 3 month, 9 month, 15 month
Emotional and behavioral engagement in learning
Time frame: Baseline, 3 month, 9 month, 15 month
Fidelity to the intervention
Time frame: Weekly during intervention delivery
Acceptability - counselors: A self-report measure, Counselor Feedback Form
Time frame: 3 month, 15 month
Acceptability - adolescents: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)
Time frame: 3 month, 15 month
Patterns in qualitative data
Time frame: 3 month
Attendance
Time frame: Weekly during IPT-AST
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 4 Nov 2026.
- Derived from this study: PubMed 39480285Young JF, Jones JD, Schwartz KTG, So A, Dysart GC, Kanine RM, Gillham JE, Gallop R, Davis M. Telehealth-delivered depression prevention: Short-term outcomes from a school-based randomized controlled trial. J Consult Clin Psychol. 2025 Apr;93(4):213-225. doi: 10.1037/ccp0000913. Epub 2024 Oct 31.
- Individual participant dataSharing planned: Yes. The raw data will be entered into a de-identified electronic database and double-checked for accuracy. After data cleaning and quality assurance procedures are completed, pertinent sets of data will be converted into analytic datasets for statistical analyses. Additional variables may be derived for data analysis purposes. The cleaned, de-identified dataset, including additional derived variables, will be made accessible per IES data access requirements at the time that findings are published in a peer-reviewed journal. Data will be available for 10 years from that time.
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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.
Jami Young, PhD principal investigator
CHOP, University of Pennsylvania Perelman School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy - Adolescent Skills Training and Services as usual in people with Depressive Symptoms, run by Children's Hospital of Philadelphia 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 20 inclusion and 12 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 4 Nov 2026. 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?
Depression symptoms (time frame: Screen, baseline, 2 month, 3 month, 9 month, 15 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04109716, which also lists 1 linked publication.
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 4 Nov 2026.