Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth

Mental Disorders Clinical Trial

Official title:

Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth: A Pilot Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540746
• Other study ID #: 15-312
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2020
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders

Intervention

Behavioral:
• ERG Skills Training
Group-based Dialectical Behavior Therapy Skills Training for 12 weeks
• Motivational Enhancement
Three week Motivational Enhancement group
• Family Skills Training
12-week group-based family skills training using Family Connections model

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton - Youth Wellness Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Hamilton Academic Health Sciences Organization

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

Soler J, Pascual JC, Tiana T, Cebrià A, Barrachina J, Campins MJ, Gich I, Alvarez E, Pérez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Emotion Regulation throughout 12-week ERG group, at post ERG group and 16-week follow-up to group.	The Difficulties in Emotion Regulation Scales is a 36-item self-report measure of emotion dysregulation with adequate psychometric properties.	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	GAIN-Q3-MI-ONT	The GAIN-Q3-MI-ONT includes the following scales: School Problems, Work Problems, Health Problems, Sources of Stress, Risk Behaviours, Internalizing Disorders, Externalizing Disorders, Substance Disorders, Crime & Violence and Total Disorder. For most individual screeners, internal consistency is good to excellent (alpha > .7) for adolescents and adults.	Baseline (2 weeks pre-ERG ST) and post-treatment (week 12 of ERG-ST)
Secondary	Sheehan Disability Scale	Functioning will be measured using the Sheehan Disability Scale, a self-report measure of functioning in: home, work/school, and the social realm.	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	Kessler Psychological Distress Scale (K-10)	Psychological distress will be measured using the K-10, a brief and well-validated instrument.	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	Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)	The DBT-WCCL which has adequate validity and reliability, will be used as a measure of coping skills.	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	The Depression Anxiety and Stress Scales 21 (DASS-21)	The Depression Anxiety and Stress Scales 21 (DASS-21) is a 21-item short-form measure of depression, anxiety and stress. Reliability, measured using Cronbach's alpha, has been shown to be adequate: alpha = .93 for the total scale. The DASS-21 has shown good convergent and discriminant validity when compared with other measures of depression and anxiety.	Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary	Burden Assessment Scale	The Burden Assessment Scale, which assesses levels of objective and subjective burden, and the Perceived Burden Scale, which assesses interpersonal burden and role strain, will be used as a measure of caregiver burden.	Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary	Modified M.I.N.I. Screener (MMS)	The MMS is designed to identify people who need a mental health assessment, covering mood disorders, anxiety and psychotic disorders.	Baseline (2 weeks pre-ERG ST)
Secondary	Lifetime Suicide Attempt Self Injury (L-SASI)	The L-SASI is an interview to collect lifetime history details of non-suicidal self-injury and suicidal behaviour. The interview will be used to exclude individuals who have had moderate to severe self-harm within the past year.	Baseline (2 weeks pre-ERG ST)
Secondary	The International Personality Disorder Examination (IPDE)	This measure will be used to determine a probable or negative diagnosis of BPD in order to support the diagnosis of BPD exclusion criteria.	Baseline (2 weeks pre-ERG ST)
Secondary	Patient Health Questionnaire (PHQ)	A diagnostic tool that will be used as a screener for depression, anxiety, eating disorders and alcohol use.	Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary	Readiness for Change	Participants will indicate their readiness to engage in treatment using the Readiness for Change questionnaire which was derived directly from the GAIN-Q3.	Baseline (2 weeks pre-ERG ST), Week 1 of ERG ST
Secondary	Validating and Invalidating Response Scale (VIRS-kids)	VIRS-kids is a measure of how much a caregiver's validation and invalidation impacts a youth's emotional regulation, behavior and care giver-youth relationship satisfaction.	Baseline (2 weeks pre-ERG ST), Week 1 and 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary	The M.I.N.I. International Neuropsychiatric Interview	This is a brief structured interview for the major psychiatric disorders in the DSM. It assesses for: major depressive episode, suicidality, manic episode, bipolar disorders, panic disorder, agoraphobia, social phobia, obsessive-compulsive disorder, posttraumatic stress disorder, alcohol abuse and dependence, substance use and dependence, psychotic disorders, anorexia nervosa, bulimia nervosa, generalized anxiety disorder. The M.I.N.I. will be used to ensure that exclusion criteria are not being met.	Baseline (2 weeks pre-ERG ST) and Week 12 of ERG ST
Secondary	Borderline Symptom List 23 (BSL-23)	The BSL-23 will be used to screen for Borderline Personality Disorder (BPD) symptoms and self-harm behaviours.	Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary	Brief Treatment History Interview (B-THI)	A selection of questions from the B-THI that contains face-valid questions will be used to assess for hospitalization and psychiatric emergency use, psychotropic medication and receipt of ancillary psychotherapy.	Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary	Family Assessment Device (FAD)	FAD is a 53 item self-report measure designed to measure family function (31). The FAD is made up of seven scales which measure Problem Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, Behaviour Control and General Functioning. The reliability, measured using Cronbach's alpha, ranged from 0.72 (Roles and Behaviour Control) to 0.92 (General Functioning).	Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary	Texas Grief Inventory	The Texas Grief Inventory, which has three subscales: grief (15 items), mastery (15 items) and empowerment (19 items), will be used to measure caregivers' sense of empowerment.	Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Secondary	Adult Behaviour Checklist (ABCL)	The Adult Behaviour Checklist for ages 18-59 (ABCL) is a checklist used to obtain information on a range of mental health and substance use concerns. The family/friends will report on the youth's difficulties. Authors report internal consistency alphas ranging from 0.78 to 0.85 and test-retest reliability ranging from r = 0.73-0.92.	Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST