Mental Disorders Clinical Trial
Official title:
Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth: A Pilot Randomized Trial
The aim of this pilot study is to examine a brief manualized treatment, Emotional Regulation
Group Skills Training (ERG ST), which has shown promise with high-risk youth presenting with
a range of mental health concerns. The investigators will examine the effectiveness of a ERG
ST group, as well as two additional components to which clients will be randomized: a
motivational enhancement (ME) pre-treatment, and family skills treatment (FAM). This project
will be the first to combine and test these modules as a transdiagnostic early intervention
for youth in the early stages on mental illness. This pilot trial will answer the following
questions: 1) What is the response rate to ERG ST compared to ERG ST plus FAM, and who
benefits? 2) What is the response rate to a ME pre-treatment, and who benefits? 3) What is
the acceptability of this treatment?
The ME pre-treatment will consist of four weekly one and a half hour sessions. The 12-week
ERG ST will consist of 12 weekly two-hour sessions with 4-12 youths per group. The 12-week
FAM will consist of 12 weekly two-hour sessions, with 16-20 caregivers per group. This study
will use a two-stage randomization design to allow for balanced groups if there is
differential attrition after pre-treatment. The following are the four treatment
combinations: ERG ST; ERG ST+FAM; ME+ERG ST; ME+ERG ST+FAM. Four subjects will be enrolled in
the study and randomized. The primary outcome is to improve emotion dysregulation in
participants. Emotion dysregulation will be measured using the Difficulties in Emotion
Regulation Scales (DERS).
The goal of this pilot study was to carry out a randomized controlled trial to investigate
whether motivational enhancement therapy (MET) improved the treatment effects of a 12-week
psychological intervention, Dialectical Behaviour Therapy Skills Training (DBT-ST), for EA
presenting in the early stages of mental health difficulties. Participants were recruited
from the Youth Wellness Centre at St. Joseph's Healthcare Hamilton and McMaster University's
Student Wellness Centre in Hamilton, Canada.
Methods: Seventy-five participants were randomized to receive MET followed by DBT-ST or to
DBT-ST alone. We assessed psychological distress, emotion dysregulation, and depression and
anxiety symptoms as outcomes. Results: We found that both treatment groups had significant
reductions in emotional dysregulation, psychological distress, depression, and anxiety at
post- treatment and at the 3-month follow-up. Participants assigned to MET pre-treatment
experienced greater improvement in psychological distress at the end of treatment.
Conclusion: This pilot study provides preliminary evidence of the potential augmentation of
DBT-ST using MET in a real-world setting. Future studies should examine whether MET uniquely
augments DBT-ST through the use of a comparable pre-treatment control group.
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