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Trial of Dialectical Behaviour Therapy Interventions for Young People Experiencing Difficulty Regulating Emotions

Randomised Controlled Trial of Dialectical Behaviour Therapy Interventions for Improving Emotion Regulation and Borderline Personality Disorders Symptoms in Young People

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001023246
Acronym
DBTYPED
Enrollment
120
Registered
2018-06-19
Start date
2018-08-04
Completion date
2019-05-13
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Lives Lived Well
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to 25 Years
Healthy volunteers
No

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).

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026