Evidence map›Paper›PMID 37001917›Full record

ArticleBMJ open2023

Efficacy of a digital mental health intervention embedded in routine care compared with treatment as usual in adolescents and young adults with moderate depressive symptoms: protocol for randomised controlled trial.

Eva Szigethy, David Wolfson, Keneisha Sinclair-McBride, Kelly Williams, Grace Jhe, Erica H Lee, Mario Bialostozky, Meredith Wallace, Sonika Bhatnagar, D R Demaso and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05159713 (Randomized Control Trial to Evaluate the Efficacy of a Digital Mental Health Intervention Embedded in Routine Care Compared to Treatment As Usual in Adolescents and Young Adults with Moderate Depressive Symptoms), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 42% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05159713 nacompletednot on this map

Randomized Control Trial to Evaluate the Efficacy of a Digital Mental Health Intervention Embedded in Routine Care Compared to Treatment As Usual in Adolescents and Young Adults with Moderate Depressive Symptoms

TypeinterventionalSponsorUniversity of PittsburghRan2022 to 2024Enrolled185ConditionsDepressionArmsdCBI, Treatment as Usual
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 1 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Eva SzigethyDepartment of Psychiatry and Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA szigethye@upmc.edu.ORCID 0000-0001-6783-581X
David WolfsonDepartment of Pediatrics, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA.
Keneisha Sinclair-McBridePsychiatry and Behavioral Sciences, Boston Children's Hospital, Boston, Massachusetts, USA.
Kelly WilliamsUniversity of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA.
Grace JhePsychiatry and Behavioral Sciences, Boston Children's Hospital, Boston, Massachusetts, USA.
Erica H LeePsychiatry and Behavioral Sciences, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-2370-9288
Mario BialostozkyRady Children's Hospital-San Diego, San Diego, California, USA.ORCID 0000-0002-6315-5849
Meredith WallaceUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Sonika BhatnagarChildren's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, USA.
D R DemasoDepartment of Psychiatry, Boston Children's Hospital, Boston, Massachusetts, USA.
Donald M YealyDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Kathryn HollenbachRady Children's Hospital-San Diego, San Diego, California, USA.
Boston Children's Hospital · USUniversity of Pittsburgh · USRady Children's Hospital-San Diego · USUPMC Health System · USChildren's Hospital of Pittsburgh · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThere are unmet mental health needs of depressed adolescents and young adults (AYAs) across the USA. Behavioural technology adequately integrated into clinical care delivery has potential to improve care access and efficiency. This multisite randomised controlled trial evaluates how a coach-enhanced digital cognitive behavioural intervention (dCBI) enhances usual care for depressed AYAs in paediatric practices with minority enriched samples. METHODS AND ANALYSIS: Participants (n=750) ages 16-22 who meet threshold criteria for depressive severity (Patient Health Questionnaire-9; PHQ-9 score 10-24) will be recruited through paediatric practices across three academic institutions (Boston, Pittsburgh and San Diego). Participants will be randomised to 12 weeks of dCBI+treatment as usual (TAU) (n=450) or TAU alone (n=300) in outpatient paediatric practices. Assessments will be completed at baseline, 6 weeks and 12 weeks with the primary outcome being improvement in clinician-rated and self-reported depressive severity (Children's Depression Rating Scale-Revised and PHQ-9) and secondary outcomes being self-reported suicidal ideation (item 9 on PHQ-9), anxiety severity (Generalised Anxiety Disorder), general quality of life (Satisfaction with Life Scale) and general functioning (Children's Global Assessment Scale). The study design is an intent-to-treat mixed effects regression with group, and covariates nested within the sites. ETHICS AND DISSEMINATION: All participants or their parent/guardian (under 18 years or unemancipated) will give informed consent to a study team member. All data are expected to be collected over 18 months. The Institutional Review Board (IRB) is a board at each institution in the United States that reviews and monitors research involving human subjects. IRB approval from the University of Pittsburgh was obtained on 30 November 2021 (STUDY21080150), from the University of California San Diego's Human Research Protection Program IRB on 14 July 2022 (802047), and from the Boston Children's Hospital IRB on 25 October 2022 (P00040987). Full study results are planned to be published within 2 years of initial study recruitment (October 2024). Dissemination of findings will occur in peer-reviewed journals, professional conferences and through reports to participating entities and stakeholders. TRIAL REGISTRATION NUMBER: NCT05159713; ClinicalTrials.gov.

Indexed as

DepressionMental HealthAdolescentAdultAnxietyAnxiety DisordersChildHumansQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeYoung Adultdepression & mood disordersmental healthtelemedicine

Identifiers

PMID37001917
PMCPMC10069502
OpenAlexW4362522334

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.