Mental DisordersNCT02540746
Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth
A study testing ERG Skills Training, Motivational Enhancement and Family Skills Training in people with Mental Disorders, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Mental Disorders
- What is being tested?
- ERG Skills Training, Motivational Enhancement and Family Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Help-seeking youth (ages 17-25 years)
- Literacy in English
- Early stage mental health concerns of mild to moderate severity
- Emotional dysregulation
Who cannot join
- Diagnosis of Borderline Personality Disorder
- Diagnosis of Anorexia Nervosa or Bulimia Nervosa
- Diagnosis of Posttraumatic Stress Disorder (current)
- Moderate to Severe Depression (current)
- Bipolar Disorder and related disorders
- Diagnosis of Schizophrenia and other psychotic disorders
Show all 11Show fewer
- Diagnosis of Antisocial Personality Disorder (ASPD)
- DSM-5 Substance Use disorder of Moderate or Severe severity (current)
- Moderate to Severe Self-Harm behaviour within past year
- Hospital admission for mental health concerns within past 6 months
- Multiple (2+) Psychiatric Emergency Service visits within past 6 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare Hamilton - Youth Wellness Centre
Hamilton, Ontario, L8P4W6
About this study
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).
Read the 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.
- Conditions
- Mental Disorders
- Being tested
- ERG Skills Training, Motivational Enhancement, Family Skills Training
- Keywords
- Emotional Dysregulation, Early Intervention, Youth Mental Health, Staging, Motivational Enhancement, Family Connections, Family Skills Training
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERG Skills TrainingBehavioural
Group-based Dialectical Behavior Therapy Skills Training for 12 weeks
Motivational EnhancementBehavioural
Three week Motivational Enhancement group
Family Skills TrainingBehavioural
Also called Family Connections
12-week group-based family skills training using Family Connections model
| Study group | Role | What they receive |
|---|---|---|
| ERG Skills Training | Experimental | ERG Skills Training for 12 weeks Receives: Behavioral: ERG Skills Training |
| ERG Skills Training + ME | Experimental | ERG Skills Training for 12 weeks preceded by Motivational Enhancement for 4 weeks Receives: Behavioral: ERG Skills Training; Behavioral: Motivational Enhancement |
| ERG Skills Training + FAM | Experimental | ERG Skills Training with concurrent 12-week Family Skills Training Receives: Behavioral: ERG Skills Training; Behavioral: Family Skills Training |
| ERG Skills Training + ME + FAM | Experimental | ERG Skills Training with concurrent 12-week Family Skills Training preceded by Motivational Enhancement for 4 weeks Receives: Behavioral: ERG Skills Training; Behavioral: Motivational Enhancement; Behavioral: Family Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (18)
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.
Measured: Baseline (2 weeks pre-ERG ST) and post-treatment (week 12 of ERG-ST)
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.
Measured: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
Kessler Psychological Distress Scale (K-10)
Psychological distress will be measured using the K-10, a brief and well-validated instrument.
Measured: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST)
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.
Measured: Baseline (2 weeks pre-ERG ST)
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.
Measured: Baseline (2 weeks pre-ERG ST)
Patient Health Questionnaire (PHQ)
A diagnostic tool that will be used as a screener for depression, anxiety, eating disorders and alcohol use.
Measured: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST), Week 1 of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST), Week 1 and 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST) and Week 12 of ERG ST
Borderline Symptom List 23 (BSL-23)
The BSL-23 will be used to screen for Borderline Personality Disorder (BPD) symptoms and self-harm behaviours.
Measured: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
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).
Measured: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
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.
Measured: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Responsible party
- Principal investigator, Robert B Zipursky, MD, St. Joseph's Healthcare Hamilton
- Investigators
- Robert B Zipursky, MD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540746
- Sponsor's protocol ID
- 15-312
- Status last verified
- Apr 2020
- First submitted
- 27 Aug 2015
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17908024Soler 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.
PubMed 19246029
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Treatment for Early Stage Mental Health Problems in Youth: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT02540746
- Acronym / sponsor ID
- 15-312
- Conditions
- Mental Disorders
- Keywords
- Emotional Dysregulation, Early Intervention, Youth Mental Health, Staging, Motivational Enhancement, Family Connections, Family Skills Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Hamilton Academic Health Sciences Organization
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ERG Skills Training | Experimental | Behavioral: ERG Skills TrainingERG Skills Training for 12 weeks |
| ERG Skills Training + ME | Experimental | Behavioral: ERG Skills Training, Behavioral: Motivational EnhancementERG Skills Training for 12 weeks preceded by Motivational Enhancement for 4 weeks |
| ERG Skills Training + FAM | Experimental | Behavioral: ERG Skills Training, Behavioral: Family Skills TrainingERG Skills Training with concurrent 12-week Family Skills Training |
| ERG Skills Training + ME + FAM | Experimental | Behavioral: ERG Skills Training, Behavioral: Motivational Enhancement, Behavioral: Family Skills TrainingERG Skills Training with concurrent 12-week Family Skills Training preceded by Motivational Enhancement for 4 weeks |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Help-seeking youth (ages 17-25 years)
- Literacy in English
- Early stage mental health concerns of mild to moderate severity
- Emotional dysregulation
Key exclusion criteria (11 listed)
- Diagnosis of Borderline Personality Disorder
- Diagnosis of Anorexia Nervosa or Bulimia Nervosa
- Diagnosis of Posttraumatic Stress Disorder (current)
- Moderate to Severe Depression (current)
- Bipolar Disorder and related disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERG Skills TrainingGroup-based Dialectical Behavior Therapy Skills Training for 12 weeks | Behavioural | ERG Skills Training, ERG Skills Training + FAM, ERG Skills Training + ME, ERG Skills Training + ME + FAM |
| Motivational EnhancementThree week Motivational Enhancement group | Behavioural | ERG Skills Training + ME, ERG Skills Training + ME + FAM |
| Family Skills TrainingAlso: Family Connections12-week group-based family skills training using Family Connections model | Behavioural | ERG Skills Training + FAM, ERG Skills Training + ME + FAM |
Primary outcome
Change from Baseline in Emotion Regulation throughout 12-week ERG group, at post ERG group and 16-week follow-up to group.
Time frame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
The Difficulties in Emotion Regulation Scales is a 36-item self-report measure of emotion dysregulation with adequate psychometric properties.
18 secondary outcomes
GAIN-Q3-MI-ONT
Time frame: Baseline (2 weeks pre-ERG ST) and post-treatment (week 12 of ERG-ST)
Sheehan Disability Scale
Time frame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
Kessler Psychological Distress Scale (K-10)
Time frame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
Dialectical Behaviour Therapy Ways of Coping Checklist (DBT-WCCL)
Time frame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST
The Depression Anxiety and Stress Scales 21 (DASS-21)
Time frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Burden Assessment Scale
Time frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Modified M.I.N.I. Screener (MMS)
Time frame: Baseline (2 weeks pre-ERG ST)
Lifetime Suicide Attempt Self Injury (L-SASI)
Time frame: Baseline (2 weeks pre-ERG ST)
The International Personality Disorder Examination (IPDE)
Time frame: Baseline (2 weeks pre-ERG ST)
Patient Health Questionnaire (PHQ)
Time frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Readiness for Change
Time frame: Baseline (2 weeks pre-ERG ST), Week 1 of ERG ST
Validating and Invalidating Response Scale (VIRS-kids)
Time frame: Baseline (2 weeks pre-ERG ST), Week 1 and 12 of ERG ST and 12 weeks after the end of ERG ST
The M.I.N.I. International Neuropsychiatric Interview
Time frame: Baseline (2 weeks pre-ERG ST) and Week 12 of ERG ST
Borderline Symptom List 23 (BSL-23)
Time frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Brief Treatment History Interview (B-THI)
Time frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Family Assessment Device (FAD)
Time frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Texas Grief Inventory
Time frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Adult Behaviour Checklist (ABCL)
Time frame: Baseline (2 weeks pre-ERG ST), Week 12 of ERG ST and 12 weeks after the end of ERG ST
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 17908024McGorry 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.
- Background: PubMed 19246029Soler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert B Zipursky, MD principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERG Skills Training, Motivational Enhancement and Family Skills Training in people with Mental Disorders, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Emotion Regulation throughout 12-week ERG group, at post ERG group and 16-week follow-up to group. (time frame: Baseline (2 weeks pre-ERG ST), Weeks 1, 4, 9 and 12 of ERG ST and 12 weeks after the end of ERG ST). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02540746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.