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Trial registered on ANZCTR


Registration number
ACTRN12618001023246
Ethics application status
Approved
Date submitted
13/06/2018
Date registered
19/06/2018
Date last updated
3/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of Dialectical Behaviour Therapy Interventions for Young People Experiencing Difficulty Regulating Emotions
Scientific title
Randomised Controlled Trial of Dialectical Behaviour Therapy Interventions for Improving Emotion Regulation and Borderline Personality Disorders Symptoms in Young People
Secondary ID [1] 295175 0
Nil known
Universal Trial Number (UTN)
U1111-1215-5303
Trial acronym
DBTYPED
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Emotion Dysregulation 308308 0
Borderline Personality Disorder 308309 0
Condition category
Condition code
Mental Health 307310 307310 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised Controlled Trial of DBT Interventions for Young People with Emotion Dysregulation

- Arm 1: 8-week intervention
- Arm 2: 16-week intervention

Intervention Description:

This is a study of Dialectical Behaviour Therapy (DBT) interventions for young people (aged 16-25 years). Participants in this study will be randomly allocated to a 16-week or 8-week Dialectical behaviour therapy (DBT)-informed program. The 8-week group will receive weekly 90-minute DBT-informed skills training, in a group setting (approx. 10 people). The 16-week groups will receive an intensive DBT-informed intervention (including weekly 90-minute group skills training sessions, weekly 50-minute individual counselling, and optional phone counselling with a DBT practitioner 12 hours per day). Both DBT interventions will be delivered by qualified mental health practitioners, certified in DBT, who are working at Headspace, Southport. 

Rationale:

Previous research has predominantly examined the efficacy of DBT in reducing self-harming or suicidal tendencies, emotion regulation and BPD symptoms in adult populations, revealing support in a range of therapeutic settings (Groves, Backer, Van den Bosch & Miller, 2011; Stoffers et al., 2012). Success of the therapy with adult populations has prompted its adaptation to youth populations, but empirical research on DBT for youth is more limited. While much of the research on adolescents/young adult populations is quasi-experimental, research to date presents promising findings.

Participants:

The young people in this will be referred to Headspace Southport by local clinicians. Referred young people will be screened by the research team, via telephone, before being randomised to a DBT group (16 week or 8 week). To be included, participants must meet a certain level of symptoms of emotion dysregulation and borderline personality disorder. 

16-week DBT program

Physical and informational Materials used: 

o participant information sheet
o diary cards
o Online surveys at baseline, 8 weeks, 16 weeks, and 24 weeks (using qualtrics).
o Fidelity checklists for group and individual sessions
o Attendance sheets for group and individual sessions
o DBT Training manual/group skills weekly-plan for DBT providers
o DBT-relevant handouts given to participants during DBT group- skills sessions and individual DBT counselling sessions, for the purposes activities or self-learning. 

Note: The material delivered to participants during DBT group skills sessions was created by the lead clinician on the project, a senior social worker at headspace Southport, trained in DBT. The materials were created, based on the guidelines set out by DBT founder, Marsha Linehan in her book “DBT Skills Training Manual – Second Edition” (Linehan, 2015). See reference list in “public notes” section for citation. While the DBT group skills sessions closely followed the Linehan’s DBT manual, the sessions also contained some activities (e.g. mindfulness activities), that were added by the lead clinician, based on clinical experience. All DBT practitioners followed the same structure set out by the lead clinician, for each DBT group skills session. The same manual was used by DBT clinicians to guide their individual DBT counselling sessions, with clients in the 16-week group. 

Procedures:

Pre-commitment work: Part of the full DBT program is pre-commitment work. To include this component of DBT in the RCT, we will randomise participants to their group (8-week or 16-week) just over two weeks before their first DBT session. This will allow two weeks for each clinician to engage with the 16-week client(s) (participants) they have been assigned, and complete pre-commitment work with them. This work will include up to 3 brief engagements to build rapport, clarify the details of the program, and complete various 'commitment to therapy' contracts with the client.

16-week Program Details:

o Weekly DBT group skills workshops (90 minutes) and weekly individual DBT counselling (50 minutes) with young person’s assigned DBT practitioner. Individual sessions follow Marsha Linehan’s DBT model for individual counselling, and are aimed at ‘concreting’ skills learned in group sessions, and addressing personal issues.
o DBT group skills sessions and individual counselling sessions are based on Marsha Linehan’s (psychologist who created DBT) model of DBT, as trained by Peter King at CMHE (centre for mental health education)

Who will deliver the intervention?

o Certified mental health professionals (e.g. psychologists, social workers, occupational therapists) working at Headspace (Southport) who are trained and certified to deliver Dialectical Behaviour Therapy (by Peter King from CMHE). 

Mode of delivery
- face to face group sessions (group size: approximately 10 people per group).
- Telephone for initial screening 
- Telephone engagement by DBT practitioners for initial contact
- Telephone coaching available for crisis situations 
- Online surveys 

Number of times the intervention will be delivered 
- 6 separate groups of 16-week DBT program throughout the RCT (10 people per group; N = 60) 
- for each person: 16 x 90 minute group sessions, once/week for 16 weeks
- Period of time: 3 waves of 2 x 16-week DBT groups. First wave Beginning September 2018, 3rd wave ending August 2019

Location 
- Headspace, Southport (youth mental health clinic)

Personalising the intervention to individuals:

- What: The individual DBT counselling sessions follow DBT guidelines, however, they are ‘tailored’ to address participants’ individual circumstances (e.g. life issues). In this way, it could be said that intervention is personalised, in the 16-week arm.

- Why: The 16-week, intensive DBT program involves individual DBT-informed counselling. By its nature, individual counselling is personalised to individuals’ needs.

- When: individual counselling sessions once per week (50 minutes), every week, for 16 weeks.

- How: The participants are randomised to a DBT group (16-week vs 8 week). The lead DBT clinician at Headspace Southport ‘matches’ each person who has been allocated to the 16-week program, with the most suitable DBT practitioners for them, for individual counselling. 

Adherence and fidelity assessment: 

o How: DBT practitioners at headspace, Southport mark “Fidelity checklists” for both group and individual sessions. These checklists are designed to assess whether each group or individual session has addressed the material required to adhere to DBT. The DBT clinicians in this RCT adhere to DBT manuals/training/checklists, as informed by Peter King’s (CMHE) training of Marsha Linehan’s DBT procedures (creator of DBT). 

o Whom: The DBT practitioners at Headspace, Southport are responsible for ensuring that they address the topics listed on the fidelity checklist (for every group and/or individual session). The lead clinician on this DBT project, a senior clinician at Headspace, is involved in overseeing the adherence to fidelity checklist. Fidelity is addressed in fortnightly clinician supervision sessions. The DBT groups are delivered by 2 practitioners, partially, to increase likelihood of fidelity by practitioners. As an outside party, the research team at the university of Queensland (who are working in collaboration ) also provide guidance on fidelity for this RCT.
Intervention code [1] 301515 0
Treatment: Other
Intervention code [2] 301516 0
Behaviour
Comparator / control treatment
DBT as usual: 8 week DBT group skills training (active control)

Intervention: 8-week DBT Program

Physical and informational Materials used: 

o Participant information sheet
o Some DBT-relevant handouts given to participants during DBT group- skills sessions, for the purposes activities or self-learning. 
o Online surveys at baseline, 8 weeks, 16 weeks, and 24 weeks (using qualtrics).
o Diary cards 
o Attendance sheets for group sessions
o DBT Training manual/group skills weekly-plan for DBT providers

8-week DBT program - Procedures:

Pre-commitment work is not usually involved in the 8-week DBT skills training groups. Those participants randomly assigned to the 8-week group will still receive brief information regarding commitment prior to randomisation (but there is no contract, and they do not have an assigned clinician for individual therapy). This will occur during their screening call with the research assistant, emphasising the level of commitment required to be eligible for (and remain involved in) the 8 and 16 week programs (e.g. 3 consecutive sessions missed results in exclusion from DBT).

Procedures, activities, and/or processes used:
o Weekly DBT group skills workshops (90 minutes) 
o DBT group skills sessions are based on Marsha Linehan’s (psychologist who created DBT) model of DBT, as trained by Peter King at CMHE (centre for mental health education) 

Who will deliver the intervention:
o Certified mental health professionals (e.g. psychologists, social workers, occupational therapists) working at Headspace (Southport) who are trained and certified to deliver Dialectical Behaviour Therapy (by Peter King from CMHE). 

Mode of delivery
- face to face group sessions (group size: approximately 10 people per group).
- Telephone for initial screening 
- Telephone engagement by DBT practitioners for initial contact
- Telephone coaching available for support outside of session times 
- Online surveys 

Number of times the intervention will be delivered 
- 6 separate groups of 8-week DBT program throughout the RCT (10 people per group; N = 60) 
- for each group: 8 x 90 minutes group sessions, once/week for 8 weeks
- period of time: 3 waves of 2 x 8-week DBT groups. First wave Beginning September 2018, 3rd wave ending August 2019

Location 
- Headspace, Southport (youth mental health clinic)
Control group
Active

Outcomes
Primary outcome [1] 306288 0
Emotion Regulation

- Measured using the Difficulties in Emotion Regulation Scale (DERS) (Gratz
& Roemer, 2004): The DERS was designed to be a comprehensive measure of emotional dysregulation. This is achieved by tapping into the emotional dimensions of; awareness and understanding of emotion, acceptance of emotions, ability to engage in goal directed behaviour whilst refraining from detrimental behaviours when experiencing negative emotions and access to effective emotion regulation strategies. The DERS achieves this by using a five point Likert scale ranging from 1 “almost never” to 5 “almost always”. The final score of the DERS provides insight into how the respondent regulates their emotions, their awareness of their own emotional state and their ability to control their emotions.
Timepoint [1] 306288 0
- Measured as a baseline measure during screening phone call (approx. 2-5 weeks before the beginning of DBT round), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).

- Note: It is not problematic to measure this 'baseline measure' early (during the screening call, not the baseline survey), because this measure is not "time-dependent" (is not asked in reference to a time frame e.g. "in the past month").
Primary outcome [2] 306314 0
Borderline Personality Disorder Symptoms

- Measured using the International Personality Disorder Examination (IPDE) (Loranger, Janca & Satorius, 1997): The IPDE is a semi-structured clinical interview designed as a standardised diagnostic tool for identifying mental health disorders. The scale being used in this experiment uses a dichotomous (true/ false) scoring procedure to identify personality traits indicative of a personality disorder. The subscale for borderline personality disorder will be used.
Timepoint [2] 306314 0
Measured as a baseline measure during screening phone call (approx. 2-5 weeks before the beginning of DBT round; non time-dependent measure), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).

- Note: It is not problematic to measure this 'baseline measure' early (during the screening call, not the baseline survey), because this measure is not "time-dependent" (is not asked in reference to a time frame e.g. "in the past month").
Secondary outcome [1] 348087 0
Suicidal Ideation:

- Measured using the Mini- International Neuropsychiatric Interview (M.I.N.I.) Suicidality screen (Sheehan et al., 1998): The M.I.N.I. suicidality score is taken from the larger standardised Mini- International Neuropsychiatric Interview. As the name suggests, it aims to assess whether the respondent has been suicidal and the magnitude of their suicidality. The scale uses dichotomous response selection with the options being “yes” and “no”.

Timepoint [1] 348087 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [2] 348146 0
Mindfulness
- Measured using the 5 Facet Mindfulness Questionnaire – Short Form (FFMQ-SF; Bohlmeijer et al., 2011): The FFMQ-SF is a 24-item scale, found to be highly reliable and valid, assessing different aspects of mindfulness.
Timepoint [2] 348146 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [3] 348147 0
Depression

- Measured using the Depression Anxiety Stress Scale (DASS) (Lovibond et al., 1995): The DASS has been designed to measure the magnitude of three significant emotional states; depression, anxiety and stress. This is achieved by use of a four point Likert scale that ranges from 0 “did not apply to me at all” to 3 “applied to me very much or most of the time”. The resulting score provides feedback about how the respondents functioning over the past week and how each of these negative emotions has been effecting them.
Timepoint [3] 348147 0
- Measured at baseline 2 (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [4] 348148 0
Functioning

- Measured using the Multidimensional Assessment of Adolescent Functioning (MAFS) (Wardenaar, Johanna, Wigman, et. al., 2013): The MAFS is a 23 item scale, designed to measure everyday functioning in adolescents. The is achieved by use of three separate subscales that tap into: family-related functioning, peer-related functioning and general functioning. The MAFS uses a four point Likert scale that ranges from 1 “not at all/ rarely” to 4 “always/ almost always”. The subscales each provide a separate snapshot into a different domain of functioning and when brought together produce simple yet effective evaluation of the respondents general functioning.
Timepoint [4] 348148 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [5] 348150 0
Severity of Drug Use

Measured using the Australian Treatment Outcomes Profile (ATOP) (Ryan, Holmes, Hunt et. al, 2014): The ATOP is a modified version of the Treatment Outcomes Profile that was adapted for Australian populations. The ATOP is a short instrument that was designed to monitor outcomes in alcohol and drug treatment populations. It assess a range of domains including; substance use, health and well-being factors over a period of 28 days.
Timepoint [5] 348150 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [6] 348152 0
Quality of Life - Measured using the Assessment of Quality of Life - 6 Dimensions (AQOL-6D) (non-simplified adolescent version) (Richardson, Peacock, Hawthorne, Iezzi, Elseworth, & Day, 2012). The AQOL-6D measures six dimensions influential to ratings of quality of life then provides a global ‘utility’ score. The dimensions measured are: independent living, relationships, mental health, coping, pain and senses.
Timepoint [6] 348152 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [7] 348158 0
Anxiety

- Measured using the Depression Anxiety Stress Scale (DASS) (Lovibond et al., 1995): The DASS has been designed to measure the magnitude of three significant emotional states; depression, anxiety and stress. This is achieved by use of a four point Likert scale that ranges from 0 “did not apply to me at all” to 3 “applied to me very much or most of the time”. The resulting score provides feedback about how the respondents functioning over the past week and how each of these negative emotions has been effecting them.
Timepoint [7] 348158 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [8] 348159 0
Stress

- Measured using the Depression Anxiety Stress Scale (DASS) (Lovibond et al., 1995): The DASS has been designed to measure the magnitude of three significant emotional states; depression, anxiety and stress. This is achieved by use of a four point Likert scale that ranges from 0 “did not apply to me at all” to 3 “applied to me very much or most of the time”. The resulting score provides feedback about how the respondents functioning over the past week and how each of these negative emotions has been effecting them.
Timepoint [8] 348159 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [9] 348160 0
Coping Skills

- Measured using the Coping Inventory for Stressful Situations (CISS) (Endler & Parker, 1990): The CISS has been designed to measure task, emotional and avoidance-orientated coping styles. Respondents are asked to rate their coping styles on a five point Likert scale ranging from 1 “not at all” to 5 “very much”. The three styles of coping reflect the different ways employed by individuals when handling stressful situations and provide insight into whether they react to stress well or poorly.
Timepoint [9] 348160 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).
Secondary outcome [10] 348196 0
Childhood Trauma

The CTQ-SF is a 28-item screen for maltreatment histories for use with both clinical and non-referred populations. The questionnaire has been validated with various populations including adolescents (Bernstein et al., 2003).
Timepoint [10] 348196 0
- Measured at baseline only

- Included to assess the relationship between relationship between experiences of childhood trauma and later symptoms of borderline personality disorder and emotion dysregulation.
Secondary outcome [11] 348197 0
Impulsivity

- Measured using the Short UPPS-P Impulsive Behavior Scale (S-UPPS-P; Cyders et al., 2014). The UPPS-P model of impulsivity proposes that impulsivity as a multi-faceted and multi-dimensional construct, comprising five impulsive personality traits.
Timepoint [11] 348197 0
- Measured at baseline (3-5 days before first DBT session), 8 week follow up, 16 week follow up, 24 week follow up (24-week follow up is the primary time-point).

Eligibility
Key inclusion criteria
Inclusion Criteria:
·         Shows symptoms of emotion dysregulation and/or Borderline Personality Disorder
·         Has not done DBT before
·         Is 16-25 years old
- Scores 21.5 or over on the DERS (Difficulties in Emotion Regulation Scale) (Gratz & Roemer, 2004).
- Answers True to 3 or more items on the International Personality Disorders Examination (IPDE) (Loanger, Janca & Satorius, 1997).

 
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
·         Not fluent in spoken or written English
·         Has an unmodified hearing impairment
·         Has a current serious medical problem or traumatic injury
·         In current episode of psychosis                                                                
·         Has a moderate to severe intellectual impairment           
·         Is currently in acute alcohol or drug withdrawal
·         Is not willing to part with their current private practitioner, for the duration of the DBT program

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site". Randomisation was completed by computer at the university of Queensland (the researcher who completed the screening calls was based at Headspace, Southport, and remained blind to participants' group throughout the RCT. Other DBT practitioners undertook any tasks relating to the RCT when it was necessary to identify participants' group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Where necessary, the computer software will be programmed to allocate equal numbers of participants to groups (e.g. if one 'wave' of randomisation involved randomising participants across 2 x 8 week groups, and only 1 x 16 week groups - note: this may occur if due to the case-load of clinician at headspace, because the 16 week group group requires intensive involvement from clinicians).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2018
Actual
Date of last participant enrolment
Anticipated
13/05/2019
Actual
Date of last data collection
Anticipated
8/11/2019
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 11135 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 22955 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 299762 0
Other
Name [1] 299762 0
Lives Lived Well (NGO)
Country [1] 299762 0
Australia
Primary sponsor type
Other
Name
Lives Lived Well
Address
Level 1/55 Little Edward St, Spring Hill QLD 4000
Country
Australia
Secondary sponsor category [1] 299126 0
None
Name [1] 299126 0
Address [1] 299126 0
Country [1] 299126 0
Other collaborator category [1] 280181 0
University
Name [1] 280181 0
University of Queensland
Address [1] 280181 0
St Lucia QLD 4072
Country [1] 280181 0
Australia
Other collaborator category [2] 280182 0
Other
Name [2] 280182 0
Headspace Southport
Address [2] 280182 0
Level 1, H20 Broadwater, 1/2 Nind St, Southport QLD 4215
Country [2] 280182 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300653 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 300653 0
University of Queensland - School of Psychology, Building 24A, Level 3, Sir Fred Schonell Drive, St Lucia QLD 4072
Ethics committee country [1] 300653 0
Australia
Date submitted for ethics approval [1] 300653 0
30/04/2018
Approval date [1] 300653 0
15/05/2018
Ethics approval number [1] 300653 0
2018000419

Summary
Brief summary
Randomised Controlled Trial of DBT Interventions for
Young People with Emotion Dysregulation

1.0 Project Overview
Previous research has predominantly examined the efficacy of DBT in reducing self-harming or suicidal tendencies, BPD symptoms and improving emotion regulation in adult populations, with efficacy for DBT therapies being demonstrated across a range of therapeutic settings (Groves, Backer, van den Bosch & Miller, 2011; Stoffers et al., 2012). Despite promising research findings, the body of DBT research on younger populations is limited and lacks methodological rigour. The study is a randomised controlled trial of 120 clients, with study arms designed to mirror routine clinical care. Participants will be assessed at baseline and followed up at 8, 16 and 24 weeks. Primary outcome variables include: emotion regulation, and BPD symptoms. Secondary outcomes include: suicidal ideation, coping skills, mindfulness, depression, anxiety, stress, functioning, and severity of drug use.

4.1 Rationale/Justification

When compared to treatment as usual, there is some evidence that DBT can result in significant improvements in youth populations across a range of outcomes. Despite these promising research findings, the body of DBT research on younger populations is limited and lacks methodological rigour.

4.2 Research Aims

In this RCT we aim to investigate and compare the efficacy of two programs for young people experiencing difficulties with emotion regulation: 1) an 8-week group DBT informed skills training program; and 2) a 16-week intensive DBT program. It is hypothesised that both groups will experience improvements, but that these improvements will be greatest for the 16 week intensive DBT group compared to the 8 weeks skills training group at 24 week follow-up in terms of the: (i) primary outcome variables of emotion regulation, and BPD symptoms; and
(ii) secondary outcome variables of suicidal ideation, coping skills, mindfulness, depression, anxiety, stress, functioning, and severity of drug use.

5.0 Project Design

5.1 Project Design Overview
This project is a RCT comparing the effectiveness of two DBT interventions (8 week skills-based group training and 16 week intensive DBT program) for young people aged 16-25 years presenting to Headspace (Southport) with symptoms of emotion dysregulation and/or borderline personality disorder. Approximately 120 young people will be recruited to the project (through self-referral, with 60 per study condition. The trial will be conducted over 24 weeks. Headspace Southport (the implementation site) already delivers the 8 weeks skills-based group program and 16 week intensive DBT program on-site.
Trial website
Trial related presentations / publications
Public notes
Relevent References

Andreasson, K., Krogh, J., Wenneberg, C., Jessen, H., Krakauer, K., Gluud, C., . . . Nordentoft, M. (2016). Effectiveness of dialectical behavior therapy versus collaborative assessment and management of suicidality treatment for reduction of self-harm in adults with borderline personality traits and disorder-a randomized observer-blinded clinical trial. Depression and Anxiety, 33(6), 520-30.

Australian Institute of Health and Welfare 2016. Australia’s Health 2016. Australia’s health series no. 15. Cat. no. AUS 199. Canberra: AIHW.

Bernstein, D.P., Stein, J.A., Newcomb, M.D., Walker, E., Pogge, D., Aluvalia, T., …& Zules, W. (2003) Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse and Neglect, 27(2), 169-190.

Bohlmeijer, E., Ten Klooster, P.M., Fledderus, M., Veehof, M. & Baer, R. (2011). Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment, 18(3), 308-320.

Carpenter RW, Trull TJ. Components of emotion dysregulation in borderline personality disorder: A review. Current Psychiatry Reports. 2013;15(1):335. doi:10.1007/s11920-012-0335-2.

Chapman, A. L., Leung, D. W., & Lynch, T. R. (2008). Impulsivity and emotion dysregulation in borderline personality disorder. Journal of Personality Disorders, 22, 148–164.

Feldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. (2007). Mindfulness and Emotion Regulation: The development and initial validation of the cognitive and affective mindfulness scale-revised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190.

Glenn, C. R., & Klonsky, E. D. (2009). Emotion dysregulation as a core feature of borderline personality disorder. Journal of Personality Disorders, 23, 20–28.

Groves, S., Backer, H., Van den Bosch, W., & Miller, A. (2011). Dialectical Behaviour Therapy with adolescents. Child and Adolescent Mental Health, 17(2), pp. 65-75. Doi: 10.1111/j.1475-3588.2011.00611.x

Hughes, A. E., Crowell, S. E., Uyeji, L., & Coan, J. A. (2012). A developmental neuroscience of borderline pathology: Emotion dysregulation and social baseline theory. Journal of Abnormal Child Psychology, 40, 21–33.

McDonell, M. G., Tarantino, J., Dubose, A. P., Matestic, P., Steinmetz, K., Galbreath, H., et al. (2010). A pilot evaluation of dialectical behavioural therapy in adolescent long-term inpatient care. Child and Adolescent Mental Health, 15, 193–196.


Linehan, M., M., (2014). DBT Training Manual. New York, NY: The Guilford Press. 

Paris, J. & Zweig-Frank, H. (2001). A 27-year follow-up of patients with borderline personality disorder. Comprehensive Psychiatry, 42:482–7.

Pistorello, J., Fruzzetti, A.E., MacLane, C., Gallop, R. & Iverson, K.M. (2012). Dialectical Behavior Therapy (DBT) Applied to college students: A randomized clinical trial. Journal of Consulting and Clinical Psychology, 80(6), 982-994.

Rathus, J. H. & Miller, A. L. (2002). Dialectical behavior therapy adapted for suicidal adolescents. Suicide and Life-Threatening Behaviour, 32(2), pp. 146-157

Robins, C. J. & Chapman, A. L. (2004). Dialectical Behavior Therapy: Current status, recent developments and future directions. Journal of Personality Disorders, 18(1), pp.73-89

Santamarina, Blanco, Picado, Font, Moreno, Martínez, . . . Romero. (2017). 3.65 Dialectical behavior therapy versus supportive therapy for adolescents with suicidal Behavior: A randomized-controlled trial. Journal of the American Academy of Child & Adolescent Psychiatry, 56(10), S226-S227.

Stoffers-Winterling, J., Voellm, B., Ruecker, G., Timmer, A., Huband, N., & Lieb, K. (2012). Psychological Therapies for people with borderline personality disorder. Cochrane Database of Systematic Reviews: Developmental, Psychosocial and Learning Problems Group. Doi: 10.1002/14651858.CD005652.pub2

Swales, M., Heard, H.L., Mark, J., & Williams, G. (2000). Linehan's Dialectical Behaviour Therapy (DBT) for borderline personality disorder: Overview and adaptation. Journal of Mental Health, 9(1), pp. 7-23, DOI: 10.1080/09638230016921

Zanarini, M.C., Frankenburg, F.R., Khera, G.S, et al. (2001). Treatment histories of borderline inpatients. Comprehensive Psychiatry, 42: 144–50.
Attachments [1] 2909 2909 0 0
/AnzctrAttachments/375323-2018000419 - Approval Form HRECA .pdf (Ethics approval)
Attachments [2] 2910 2910 0 0
/AnzctrAttachments/375323(v23-07-2018-17-05-17)-2018000419 - AMENDMENT Approval Form HRECA (2).pdf (Ethics approval)

Contacts
Principal investigator
Name 84350 0
Dr Dominique De Andrade
Address 84350 0
School of Psychology, McElwain Building (24A), The University of QLD, St Lucia, Queensland 4072
Country 84350 0
Australia
Phone 84350 0
+61 433173093
Fax 84350 0
Email 84350 0
[email protected]
Contact person for public queries
Name 84351 0
Dominique De Andrade
Address 84351 0
School of Psychology, McElwain Building (24A), The University of QLD, St Lucia, Queensland 4072
Country 84351 0
Australia
Phone 84351 0
+61 433173093
Fax 84351 0
Email 84351 0
[email protected]
Contact person for scientific queries
Name 84352 0
Dominique De Andrade
Address 84352 0
School of Psychology, McElwain Building (24A), The University of QLD, St Lucia, Queensland 4072
Country 84352 0
Australia
Phone 84352 0
+61 433173093
Fax 84352 0
Email 84352 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3844Basic resultsNo 375323-(Uploaded-13-07-2021-12-46-48)-Basic results summary.docx
4083Plain language summaryNo Results: Multilevel models were used to compare th... [More Details]

Documents added automatically
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