Clinical trial NCT02540746: Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth
Official title: Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Emotional Dysregulation
Early Intervention
Youth Mental Health
Staging
Motivational Enhancement
Family Connections
Family Skills Training
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Hamilton Academic Health Sciences Organization
First posted: 2015-09-04
Enrollment: 76
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Help-seeking youth (ages 17-25 years)
2. Literacy in English
3. Early stage mental health concerns of mild to moderate severity
4. Emotional dysregulation

Exclusion Criteria:

1. Diagnosis of Borderline Personality Disorder
2. Diagnosis of Anorexia Nervosa or Bulimia Nervosa
3. Diagnosis of Posttraumatic Stress Disorder (current)
4. Moderate to Severe Depression (current)
5. Bipolar Disorder and related disorders
6. Diagnosis of Schizophrenia and other psychotic disorders
7. Diagnosis of Antisocial Personality Disorder (ASPD)
8. DSM-5 Substance Use disorder of Moderate or Severe severity (current)
9. Moderate to Severe Self-Harm behaviour within past year
10. Hospital admission for mental health concerns within past 6 months
11. Multiple (2+) Psychiatric Emergency Service visits within past 6 months

Primary outcomes:
measure: Change from Baseline in Emotion Regulation throughout 12-week ERG group, at post ERG group and 16-week follow-up to group.
timeFrame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary outcomes:
measure: GAIN-Q3-MI-ONT
timeFrame: Baseline (2 weeks pre-ERG ST) and post-treatment (week 12 of ERG-ST)
measure: Sheehan Disability Scale
timeFrame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Kessler Psychological Distress Scale (K-10)
timeFrame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)
timeFrame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
measure: The Depression Anxiety and Stress Scales 21 (DASS-21)
timeFrame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Burden Assessment Scale
timeFrame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Modified M.I.N.I. Screener (MMS)
timeFrame: Baseline (2 weeks pre-ERG ST)
measure: Lifetime Suicide Attempt Self Injury (L-SASI)
timeFrame: Baseline (2 weeks pre-ERG ST)
measure: The International Personality Disorder Examination (IPDE)
timeFrame: Baseline (2 weeks pre-ERG ST)
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Readiness for Change
timeFrame: Baseline (2 weeks pre-ERG ST), Week 1 of ERG ST
measure: Validating and Invalidating Response Scale (VIRS-kids)
timeFrame: Baseline (2 weeks pre-ERG ST), Week 1 and 12 of ERG ST and 12 weeks after the end of ERG ST
measure: The M.I.N.I. International Neuropsychiatric Interview
timeFrame: Baseline (2 weeks pre-ERG ST) and Week 12 of ERG ST
measure: Borderline Symptom List 23 (BSL-23)
timeFrame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Brief Treatment History Interview (B-THI)
timeFrame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Family Assessment Device (FAD)
timeFrame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Texas Grief Inventory
timeFrame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
measure: Adult Behaviour Checklist (ABCL)
timeFrame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton - Youth Wellness Centre
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Robert B Zipursky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGorry PD, Purcell R, Hickie IB, Yung AR, Pantelis C, Jackson HJ. Clinical staging: a heuristic model for psychiatry and youth mental health. Med J Aust. 2007 Oct 1;187(S7):S40-2. doi: 10.5694/j.1326-5377.2007.tb01335.x.
citation: Soler J, Pascual JC, Tiana T, Cebria A, Barrachina J, Campins MJ, Gich I, Alvarez E, Perez V. Dialectical behaviour therapy skills training compared to standard group therapy in borderline personality disorder: a 3-month randomised controlled clinical trial. Behav Res Ther. 2009 May;47(5):353-8. doi: 10.1016/j.brat.2009.01.013. Epub 2009 Jan 29.