Can a transdiagnostic modular cognitive-behavioral therapy (CBT) program outperform management as usual for youth with emotional and behavioral problems?
In this randomized clinical trial of 396 youths aged 6 to 16 years, the parent-reported functional impairment was significantly reduced for youth allocated to transdiagnostic modular CBT compared with management as usual. Key secondary outcomes also indicated a broad range of benefits.
This pragmatic study adds to the growing evidence that the wide-scale implementation of transdiagnostic modular CBT in nonspecialist care settings provides timely indicated prevention and quality care for help-seeking youth.
Behavioral therapy and cognitive-behavioral therapy (CBT) programs targeting a single class of problems have not been widely implemented. The population of youths with common mental health problems is markedly undertreated.
To determine the effectiveness of a new transdiagnostic CBT program (Mind My Mind [MMM]) compared with management as usual (MAU) in youths with emotional and behavioral problems below the threshold for referral to mental health care.
Design, Setting, and Participants
This pragmatic, multisite, randomized clinical trial of MMM vs MAU was conducted from September 7, 2017, to August 28, 2019, including 8 weeks of postintervention follow-up, in 4 municipalities in Denmark. Consecutive help-seeking youths were randomized (1:1) to the MMM or the MAU group. Main inclusion criteria were age 6 to 16 years and anxiety, depressive symptoms, and/or behavioral disturbances as a primary problem. Data were analyzed from August 12 to October 25, 2019.
The MMM intervention consisted of 9 to 13 weekly, individually adapted sessions of manualized CBT delivered by local psychologists. The MAU group received 2 care coordination visits to enhance usual care.
Main Outcomes and Measures
The primary outcome was change in mental health problems reported by parents at week 18, using the Strengths and Difficulties Questionnaire (SDQ) Impact scale (range, 0-10 points, with higher scores indicating greater severity of distress and impairment). Primary and secondary outcomes were assessed in the intention-to-treat population at week 18. Maintenance effects were assessed at week 26.
A total of 396 youths (mean [SD] age, 10.3 [2.4] years; 206 [52.0%] boys) were randomized to MMM (n = 197) or MAU (n = 199), with primary outcome data available in 177 (89.8%) and 167 (83.9%), respectively, at 18 weeks. The SDQ Impact score decreased by 2.34 points with MMM and 1.23 with MAU, from initial scores of 4.12 and 4.21, respectively (between-group difference, 1.10 [95% CI, 0.75-1.45]; P < .001; Cohen d = 0.60). Number of responders (≥1-point reduction in SDQ Impact score) was greater with MMM than with MAU (144 of 197 [73.1%] vs 93 of 199 [46.7%]; number needed to treat, 4 [95% CI, 3-6]). Secondary outcomes indicated statistically significant benefits in parent-reported changes of anxiety, depressive symptoms, daily functioning, school attendance, and the principal problem. All benefits were maintained at week 26 except for school attendance.
Conclusions and Relevance
In this randomized clinical trial, the scalable transdiagnostic cognitive-behavioral intervention MMM outperformed MAU in a community setting on multiple, clinically relevant domains in youth with emotional and behavioral problems.
ClinicalTrials.gov Identifier: NCT03535805
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Accepted for Publication: October 17, 2020.
Published Online: December 23, 2020. doi:10.1001/jamapsychiatry.2020.4045
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Jeppesen P et al. JAMA Psychiatry.
Corresponding Author: Pia Jeppesen, MD, PhD, Child and Adolescent Mental Health Center, Mental Health Services–Capital Region of Denmark, Research Unit, Gentofte Hospitalsvej 3A, First Floor, DK-2900 Hellerup, Denmark (firstname.lastname@example.org).
Author Contributions: Dr Jeppesen had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Jeppesen, Wolf, Plessen, Bilenberg, Thomsen, Thastum, Neumer, Pagsberg, Silverman, Correll.
Acquisition, analysis, or interpretation of data: Jeppesen, Wolf, Nielsen, Christensen, Bilenberg, Thomsen, Thastum, Neumer, Puggaard, Agner Pedersen, Pagsberg, Correll.
Drafting of the manuscript: Jeppesen, Christensen, Neumer.
Critical revision of the manuscript for important intellectual content: Jeppesen, Wolf, Nielsen, Plessen, Bilenberg, Thomsen, Thastum, Neumer, Puggaard, Agner Pedersen, Pagsberg, Silverman, Correll.
Statistical analysis: Jeppesen, Nielsen, Christensen.
Obtained funding: Jeppesen.
Administrative, technical, or material support: Jeppesen, Wolf, Christensen, Plessen, Bilenberg, Puggaard, Pagsberg.
Supervision: Jeppesen, Bilenberg, Thomsen, Neumer, Correll.
Conflict of Interest Disclosures: Dr Jeppesen reported received grants from the TrygFonden and Lundbeckfonden. Dr Christensen reported receiving support from core grant OCAY-18-774-OFIL from the Oak Foundation for the Musculoskeletal Statistics Unit, the Parker Institute, Bispebjerg, and Frederiksberg Hospital. Dr Plessen reported receiving grants from TrygFonden during the conduct of the study. Dr Bilenberg reported receiving grants from Novo Nordisk A/G and TrygFonden other project outside the submitted work. Dr Thomsen reported receiving personal fees from TrygFonden for attending steering committee meetings during the conduct of the study, speakers’ fees from Medice and Shire plc, and textbook royalties from FADL’s Forlag outside the submitted work. Prof Thastum reported receiving funding from the TrygFonden and honoraria from Dafolo A/S within the last 3 years. Mr Neumer reported receiving personal fees from TrygFonden via Psykiatrifonden outside the submitted work. Dr Pagsberg reported receiving funding from the TrygFonden, Novo Nordisk Foundation, Læge Sofus Carl Emil Friis og hustru Olga Doris Friis’ scholarship, and the Capital Region Mental Health Services Research Fund. Dr Correll reported receiving personal fees from Alkermes plc, Allergan plc, Angelini Pharma, Gedeon Richter, Gerson Lehrman Group, Intra-Cellular Therapies, Inc, Janssen Pharmaceutica/Johnson & Johnson, LB Pharma International BV, H Lundbeck A/S, MedAvante-ProPhase, Medscape, Neurocrine Biosciences, Noven Pharmaceuticals, Inc, Otsuka Pharmaceutical Co, Inc, Pfizer, Inc, Recordati, Rovi, Sumitomo Dainippon Pharma, Sunovion Pharmaceuticals, Inc, Supernus Pharmaceuticals, Inc, Takeda Pharmaceutical Company Limited, Teva Pharmaceuticals, Acadia Pharmaceuticals, Inc, Axsome Therapeutics, Inc, Indivior, Merck & Co, Mylan NV, MedInCell, and Karuna Therapeutics and grants from Janssen Pharmaceutica, Takeda Pharmaceutical Company Limited, Berlin Institute of Health, the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and the Thrasher Foundation outside the submitted work; receiving royalties from UpToDate; and holding stock options in LB Pharma. No other disclosures were reported.
Funding/Support: The Mind My Mind project was initiated by Psykiatrifonden and sponsored through unrestricted grants from the Danish TrygFonden and the Lundbeckfonden.
Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: Lisbeth Jørgensen, Kristian Bech Arendt, and Christina Magni Kjerholt developed and wrote the transdiagnostic Mind My Mind manual and taught the therapists and supervisors. Birthe Wielandt Houe served as project manager at Psykiatrifonden. We thank all the leaders, psychologists and employees in the Educational-Psychological Advisory Services in Vordingborg, Næstved, Helsingør and Holstebro, and the leaders and psychologists in the Child and Adolescent Mental Health Centers in Region Zealand, Central Denmark Region, and Capital Region of Denmark. We also thank the many children, adolescents, and parents for their study participation.
Additional Information: The project was performed through close collaboration among the project manager, the principal investigator (Dr Jeppesen), the participating municipalities, and the regional child and adolescent mental health centers. Psykiatrifonden held the legal responsibility as the data controller for the Web-based data collection. The independent research was performed in the Research Unit of the Child and Adolescent Mental Health Centre–Capital Region of Denmark.
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