Effectiveness of Transdiagnostic Cognitive-Behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: A Randomized Clinical Trial

Abstract

Importance: 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.

Objective: 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.

Interventions: 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.

Results: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT03535805.

Conflict of interest statement

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.

Figures

Figure 1.. CONSORT Diagram of Participant Flow Through the Trial

Flow includes screening, randomization, and 18- and 26-week follow-up.

Figure 2.. Change From Baseline in Impact of Child’s Mental Health Problems

Trajectory of least-squares mean scores over time for the impact of the child’s mental health problems reported by the parent (Strengths and Difficulties Questionnaire [SDQ] Impact scale score) from baseline to week 18, plus the extended follow-up to week 26. Least-squares mean estimates were calculated from repeated mixed-measure models for data at 0 to 18 weeks and from analysis of covariance models for data at 26 weeks. The analyses were based on data from the intention-to-treat population. For each group, the error bars indicate the standard errors. MAU indicates management as usual; MMM, Mind My Mind intervention.