Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth

St. Joseph's Healthcare Hamilton

Status: Completed

Conditions: Mental Disorders

Treatments: Behavioral: ERG Skills Training; Behavioral: Motivational Enhancement; Behavioral: Family Skills Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02540746

15-312

Details and patient eligibility

About

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).

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 17 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

ERG Skills Training

Experimental group

Description:

ERG Skills Training for 12 weeks

Treatment:

Behavioral: ERG Skills Training

ERG Skills Training + ME

Experimental group

Description:

ERG Skills Training for 12 weeks preceded by Motivational Enhancement for 4 weeks

Treatment:

Behavioral: Motivational Enhancement

Behavioral: ERG Skills Training

ERG Skills Training + FAM

Experimental group

Description:

ERG Skills Training with concurrent 12-week Family Skills Training

Treatment:

Behavioral: Family Skills Training

Behavioral: ERG Skills Training

ERG Skills Training + ME + FAM

Experimental group

Description:

ERG Skills Training with concurrent 12-week Family Skills Training preceded by Motivational Enhancement for 4 weeks

Treatment:

Behavioral: Family Skills Training

Behavioral: Motivational Enhancement

Behavioral: ERG Skills Training