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MindMyMindFU
Long-term Outcome of a Transdiagnostic Cognitive-behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: a 3-year Follow-up of a Randomized Clinical Trial
Sponsor study identifier
observational
396
1 country
1
Study Start
March 22, 2021
Actual (reported)Primary Completion
August 31, 2021
Actual (reported)Study Completion
September 17, 2021
Actual (reported)This is a three-year follow up of a previously completed randomized clinical trial (RCT) of a transdiagnostic cognitive and behavioral (CBT) program ("Mind My Mind" \[MMM\]) compared to management as usual (MAU) in youth with emotional and behavioral problems. The effectiveness trial (Clinical Trials Identifier: NCT03535805) evaluated an intervention for help-seeking youth with emotional and behavioral health problems below the threshold for referral to specialized treatment. The experimental intervention MMM consisted of 9-13 weekly, individual therapy sessions delivered by psychologists in a non-specialist school-based setting. The CBT-methods were organized in modules for anxiety, depression and/or behavioral problems, and the therapy was completed within 17 weeks. The MAU was enhanced by two care-coordination visits to help coordinate the usual care in the four municipalities in Denmark. The trial was conducted in four diverse municipalities in Denmark. The aim of this study is to determine the long-term effects of the transdiagnostic, modular CBT program ("Mind My Mind" \[MMM\]) compared to management as usual (MAU). The three-year follow-up of the RCT of MMM versus MAU is nested in a larger study of help-seeking youth screened for eligibility and stratified into three groups with increasing severity of problems. Youths with an intermediate level of problems were included in the RCT. We screened 573 help-seeking youths, and we included and randomized a total of 396 youths (age 6-16 years, with anxiety, depressive symptoms, and/or behavioral problems) to MMM (n=197) or MAU (n=199). The study participants comprise the 396 youths and their parents who participated in the RCT. We will use the help-seeking population and the background population in the four municipalities as reference groups. The follow-up study does not include an intervention. The long-term outcome of MMM versus MAU will be investigated using parent-reported questionnaires administered in average three years after random allocation to intervention. All study participants are followed in the Danish national registries.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 17, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 10, 2021
Actual (reported)March 18, 2021
Actual (reported)March 22, 2021
Actual (reported)August 31, 2021
Actual (reported)September 17, 2021
Actual (reported)The child's impact of mental health problems reported by the parent on the Strengths and Difficulties Questionnaire Impact Scale.
The parent-reported Strengths and Difficulties Questionnaire (SDQ) Impact Scale is scored from 0 to 10 (1, 2, 3, 4, 5, 6, 7, 8, 9, 10) with higher scores indicating more impact of mental health problems. The minimum relevant difference in impact of mental health problems measured by the SDQ Impact Scale was set at 1.0 corresponding to a change from severe to moderate, or from moderate to little-or-no impact in one of the five domains of child's life (distress, home-life, friendships, classroom learning and leisure activities). The SDQ Impact was previously measured at week 0, 2, 4, 6, 8, 10, 12, 14, 18 and 26 asking about the last six months at baseline and asking about the last month at each follow-up.
Last month at 3-year follow-up
Emotional and behavioral problems
Last month at 3-year follow-up
The study participants comprise the 396 youths (and their parents) who participated in the Mind My Mind RCT. The study participants were randomized to the experimental MMM intervention (n=197) or MAU (n=199) and followed in the trial until 26 weeks after randomization, from September 7, 2017, to August 28, 2019. The MMM consisted of 9-13 weekly, individual therapy sessions. The CBT methods were organized in modules for anxiety, depression and behavioral problems. Flowcharts described the sequencing and dosing of modules to match the problems at hand. The therapy was completed within 17 weeks, followed by a booster session after four weeks. The MAU was enhanced by two care-coordination visits (week 2 and 17). The MAU interventions included anonymous counseling, pedagogical advice, network meetings, educational support, psychological treatment, or no treatment.
The study subjects are the 396 school-aged youths who were identified with indicated need for treatment of anxiety, depressive symptoms, and/or behavioral disturbances and randomized to MMM (n=197) or MAU (n=199). The parent of each of subject will be invited to answer questionnaires to assess the long-term outcomes. We will also follow the help-seeking population (n=573) and the age-matched background population in the four municipalities (study sites) by use of data drawn from the Danish National Registries (reference groups).
Mental Health Services in the Capital Region, Denmark
Copenhagen, DK-2900, Denmark
Jeppesen P, Wolf RT, Nielsen SM, Christensen R, Plessen KJ, Bilenberg N, Thomsen PH, Thastum M, Neumer SP, Puggaard LB, Agner Pedersen MM, Pagsberg AK, Silverman WK, Correll CU. Effectiveness of Transdiagnostic Cognitive-Behavioral Psychotherapy Compared With Management as Usual for Youth With Common Mental Health Problems: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Mar 1;78(3):250-260. doi: 10.1001/jamapsychiatry.2020.4045.
Wolf RT, Puggaard LB, Pedersen MMA, Pagsberg AK, Silverman WK, Correll CU, Plessen KJ, Neumer SP, Gyrd-Hansen D, Thastum M, Bilenberg N, Thomsen PH, Jeppesen P. Systematic identification and stratification of help-seeking school-aged youth with mental health problems: a novel approach to stage-based stepped-care. Eur Child Adolesc Psychiatry. 2022 May;31(5):781-793. doi: 10.1007/s00787-021-01718-5. Epub 2021 Jan 18.
Pia Jeppesen, PhD
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
396 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2021
First Posted
March 18, 2021
Study Start
March 22, 2021
Actual (reported)School attendance: proportion of school-days within the last 4 weeks, where the child is present (no illegal absence)
Last four weeks at 3-year follow-up
Child Health Utility instrument (CHU9D)
The present day at 3-year follow-up
The Parental Stress Scale (PSS)
Present time at 3-year follow-up
The number of participants who responded defined as a SDQ Impact score reduction ≥1 points
at 3-year follow-up
The number of participants in remission defined as SDQ algorithm scores below cut-off for need of treatment
at 3-year follow-up
Psychosocial treatments
Last three months at 3-year follow-up
Contact the study team to confirm eligibility.
Wolf RT, Ratcliffe J, Chen G, Jeppesen P. The longitudinal validity of proxy-reported CHU9D. Qual Life Res. 2021 Jun;30(6):1747-1756. doi: 10.1007/s11136-021-02774-9. Epub 2021 Feb 13.
Vassard D, Rimvall MK, Wolf RT, Christensen R, Nielsen SM, Plessen KJ, Verhulst F, Bilenberg N, Thomsen PH, Thastum M, Neumer SP, Pagsberg AK, Silverman WK, Correll CU, Jeppesen P. Outcome and cost-effectiveness of transdiagnostic cognitive behavioral therapy compared with management as usual for youth with common mental health problems: Long-term results from the Mind-My-Mind randomized trial. J Child Psychol Psychiatry. 2026 Aug;67(8):1307-1320. doi: 10.1111/jcpp.70128. Epub 2026 Mar 3.
Primary Completion
August 31, 2021
Actual (reported)Study Completion
September 17, 2021
Actual (reported)Last Updated
March 23, 2023
Record last verified: 2023-03
The pseudonymous individual participant data can be made available to investigators for individual participant data meta-analyses that have been approved by independent review committees. The data access will be granted on a case-by-case basis by the principal investigator (Pia Jeppesen) after further approval by the nongovernmental organization Psykiatrifonden (who was responsible for the implementation of the MMM program in the municipalities and has the legal responsibility as the data controller for the Web-based data collection). Access will be granted to the extent permissible by the General Data Protection Regulation and the Danish Data Protection Act. Making the data available may require approval from the Danish Data Protection Authority.
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Source: ClinicalTrials.gov.
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