Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001246572
Ethics application status
Approved
Date submitted
5/11/2015
Date registered
13/11/2015
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
'THE MANAGING EMOTIONS (ME) PROGRAM'
The development of an 8 Week Dialectical Behaviour Therapy (DBT) Informed Skills Training Program including Creativity/art making exercises for the treatment of people who have difficulty managing their emotions.
Scientific title
The development of an 8 Week Dialectical Behaviour Therapy (DBT) Informed Skills Training Program including Creativity/art making exercises for the treatment of people who have difficulty managing their emotions.
Secondary ID [1] 287792 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotion Dysregulation 296674 0
Impulsive behaviour 296675 0
Condition category
Condition code
Mental Health 296901 296901 0 0
Other mental health disorders
Mental Health 296902 296902 0 0
Anxiety
Mental Health 296903 296903 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Research is based on the attendance of Skills Training Groups only, no individual therapy. Each Weekly session is 2.5 hours in duration. At each session Diary cards are discussed, a mindfulness exercise is experienced by all attendees and then skills are taught, handouts are supplied and group discussion follows.
In the 8 Week DBT Skills Training only program the final half hour of each weekly group will involve verbal discussion on when and where these skills will help individuals in the groups
In the 8 Week DBT skills training plus art making the final half hour is dedicated to making an art exercise that specifically relates to the skills taught and a small discussion is conducted in sharing images at the end of group.

8 to 10 participants will attend an 8 week Dialectical Behaviour Therapy (DBT) Skills training course.
WEEK
ONE -Introduction to Dialectical Behaviour Therapy-What is ‘Wise Mind’
TWO -Concentration on the skill of Distress Tolerance ‘Wise Mind Accepts”
THREE -Distress Tolerance skills of ‘Improving the Moment’
FOUR - Mindfulness
Observing, describing and participating in a non-judgmental, one-mindfully and effective manner -Mindfulness exercises – circuit . Identifying what we need to do to practice the options we have to improve and enjoy the moment mindfully using our 5 senses.
FIVE - Reality Acceptance- Willingness and Willfulness
SIX -Understanding our emotions and Chain analysis
Identifying and describing the difference between primary and secondary emotions and their functions
SEVEN - Goals of Interpersonal Effectiveness and How to communicate effectively.
EIGHT - Review of all diary cards and the skills you feel could assist you

8 to 10 participants will attend an 8 week Dialectical Behaviour Therapy (DBT) Skills training course plus tailored art exercises.

Dialectical Behaviour Therapy Informed Skills Training and Art Exercises 8 week program
WEEK
ONE - Introduction to Dialectical Behaviour Therapy-What is ‘Wise Mind’.
ART EXERCISE - How Skills could help build frame around us. What would Wise Mind look like? Coloured pencils
TWO - Concentration on the skill of Distress Tolerance ‘Wise Mind Accepts”
ART EXERCISE - To identify what kind of distress tolerance strategies may help
– create 7 tools before action – Texters and collage
THREE - Distress Tolerance skills of ‘Improving the Moment’
ART EXERCISE - Creating an object or image of the ‘cheerleader’ within to keep one safe whilst practicing the skills- clay
FOUR - Mindfulness - Observing, describing and participating in a non-judgmental, one-mindfully and effective manner. Mindfulness exercises – circuit . Identifying what we need to do to practice the options we have to improve and enjoy the moment mindfully - using our 5 senses
ART EXERCISE - What did it feel like to be mindful? ' watercolours'
FIVE - Reality Acceptance- Willingness and Willfulness
ART EXERCISE - Creating a representation of “Willingness” – what can you accept right now?- texters, oil pastels, collage.
SIX - Understanding our emotions and Chain analysis
Identifying and describing the difference between primary and secondary emotions and their functions
ART EXERCISE - After experiencing a primary emotion, how many secondary emotions d you experience represented by Acrylic paints on canvass
SEVEN - Goals of Interpersonal Effectiveness and How to communicate effectively.
ART EXERCISE - When I communicate well ‘How do I look” - construction found materials
EIGHT - Review of all diary cards and the skills you feel could assist you Review of all artwork. Creating an image that represents a tool box full of the skills you find most useful


A key component of DBT is teaching a client to stay a little longer than before with feeling emotional pain, validating and accepting their experience whilst moving towards changes in behaviours. The skill of managing difficult emotions is paramount to being able to gain or maintain balance in a life that has meaning and fulfilment, free from self-harm, anxiety, depression and a sense of emptiness. Adding the experience of creating images can help patients learn skills in two very different ways, verbally and experientially. Patients leave group with a concrete, original item or object to remind themselves of the skills they have learned..

Facilitators of Groups - All facilitators will receive a 74 page Manual prepared by the Prinicpal Researcher. The facilitators will attend the training free of charge and will receive a 'Certificate of Attendance' that provides 14 professional development hours with the following organizations who have endorsed the training for professional development points.
Australian and New Zealand Arts Therapy Association ANZATA
Australian Association of Social Workers AASW
Australian Counselling Association ACA
Australian Council of Mental Health Nurses ACMHN
The training is also listed on Australian Psychological Society webpage APS (APS does not endorse any training by private organizations)

Group Facilitators may already have sufficient training in DBT or may have attended the Principal Researcher's 2 Day Intensive DBT Training. The Principal Researcher will be responsible for checking this requirement and approving all facilitators are qualified and experienced group facilitators.

Group facilitators will be currently practicing Health Care Professionals, Art Therapists, Psychologists, Social Workers, Occupational Therapists, Counsellors etc. having experience in facilitating Mental Health Groups and being current members of a Professional Association relevant to their professional qualifications. DBT training will be offered to all facilitators. Facilitators must have over 12 months experience in conducting group work. Two people are required to be present for DBT Groups and it is estimated that the maximum number of DBT Trained Facilitators required would be 16 and the total number of co-facilitators (not necessarily trained in DBT would also be 16). The facilitators can be male or female.

An Outline of the Training is below:
2 DAY INTENSIVE DIALECTICAL BEHAVIOUR THERAPY TRAINING

Dialectical Behaviour Therapy (DBT) was developed by Prof. Marsha Linehan, Ph.D.,at the University of Washington in the late 1970’s. She added acceptance, dialectics and validation strategies to cognitive-behavioural treatment for patients diagnosed with borderline personality disorder (BPD) who often presented with chronic patterns of suicidal or other severe dysfunctional behaviours and named the therapy Dialectical Behaviour Therapy (DBT). In her 2nd Edition ‘DBT Skills Training Manual 2015’ she has explained how useful DBT is for many other client groups and has given examples of how DBT can be modified to assist these patients. She has also added a variety of new skills to the original modules for skills training.
It is not unusual for individuals diagnosed with BPD to also struggle with other problems -- depression, bipolar disorder, post-traumatic stress disorder (PTSD), anxiety, eating disorders, or alcohol and drug problems. It’s important to note that DBT is an “empirically-supported treatment.” for BPD sufferers. DBT skills are extremely useful for people in assisting in the management of impulsive behaviours, mood changes, emotional dysregulation, anxiety, depression and urges to use substances, food, gambling etc. to avoid or get rid of uncomfortable or intense emotions. DBT gives patients concrete skills and strategies to manage disruptive emotional experiences.
This 2 day Intensive “Dialectical Behaviour Therapy Training” is designed to assist practitioners gain knowledge of how to work with DBT as individual therapists and also as skills group facilitators. Training can be tailored to specific region’s needs and information on how to set up a DBT program including Therapists Consult groups is also detailed.
DAY 1
Biosocial Therapy of Borderline Personality Disorder, DSM1V/V, Description of Dialectical Behaviour Therapy and Statistics
5 Functions of Treatment, Standards and Modes of Treatment, Researched Model of DBT description
Dialectics and Validation
Strategies of Encouragement, Genuineness, DBT Styles of communication
Pre-Treatment Stage, Orienting and Commitment Strategies, Goals, Patients and Therapists Agreements
Stages and Targets of Treatment
Individual DBT Therapy, Crisis Intervention, Suicide Risk Assessment, Phone Coaching, Treating Wilfullness, Diary Cards, Chain Analysis
Implementing DBT in a System, DBT Consultation Team Agreements
DAY 2
Changes in 2nd Edition DBT Skills Training 2015
DBT For Adolescents and suggested Skills Training for non BPD patients in a variety of settings
Skills Training Group, Group Rules, Four skills of DBT
Mindfulness, States of Mind – Art Exercise
Distress Tolerance
Emotional Regulation
Interpersonal Effectiveness
Assumptions of DBT, Resources
Training Objectives:
Participants will:
-
1. gain knowledge of the philosophy of DBT, the structure of the therapy and statistical information on the researched model. Discussion of latest research for the use of DBT in a variety of settings.
2. gain knowledge of how to teach ‘crisis survival’ techniques and address suicide ideation, self-harm and impulsive destructive behaviours of patients
3. gain knowledge in how to work dialectically using validation and acceptance strategies with patients.
4. gain knowledge in how to look after oneself as a clinician and gain supportive supervision within the DBT frame to help assist in working with patients who present with high levels of emotional dysfunction.
5. gain knowledge of all four skills of DBT, Mindfulness, Distress Tolerance, Emotional Regulation and Interpersonal Effectives, including the additions of new skills added in 2nd Edition DBT Training 2015 (Prof Marsha Linehan)
6. gain knowledge in how to teach a skills training group
7. gain knowledge in working with many client groups that experience emotional dysregulation and working with DBT with adolescents

Expressive Therapy Clinic's Trainings are endorsed by AASW, ACMHN, ACA, ANZATA an listed on APS Website for Professional Development..
Intervention code [1] 293181 0
Treatment: Other
Comparator / control treatment
Control group is the 8 to 10 participants who attend the DBT Skills only training program
Control group
Active

Outcomes
Primary outcome [1] 296513 0
Facilitator confidence in using DBT, measured using a numerical rating scale (0-5)


Timepoint [1] 296513 0
The question on the assessment/evaluation is one question at the end of the 2 Day Intensive DBT Training as follows:

How do you rate your confidence to use DBT in your practice/work from 0 - 5?
0 - No confidence 5 - A lot of confidence
Primary outcome [2] 296514 0
The aims of the research are to test a DBT-Art approach along side a standard DBT control for efficacy

Data will be collected from both the DBT only 8 week Skills Training program and the DBT 8 week program with art making. The following data will be measured:
DBT ‘Ways of coping’ checklist .
A Detailed Questionnaire representing ways that the participant has coped with stressful events in your life. The questionnaire measures the use of 59 coping strategies from 'Never used, Rarely used, Sometimes used, Regularly used.
Timepoint [2] 296514 0
Measure will be taken in the first week of the 8 Week Skills Training Programs and again at the end of the programs.
Primary outcome [3] 296515 0
Primary outcome 3 - Outcome Rate Scale (ORS) - Assessing how participant feels in the following areas. Personal well-being, Interpersonally with family/close relationships, Socially - work, friendships, Overall - general sense of well-being
Timepoint [3] 296515 0
Primary outcome timepoint 3
Data collected at end of each weekly group.
Secondary outcome [1] 318636 0
Secondary outcome 1
Confidence in control of Emotions scale developed by Principal Investigator
Timepoint [1] 318636 0
Secondary outcome timepoint 1
Pre scale at beginning of both 8 week programs and Post at the end of the 8 week programs
Secondary outcome [2] 318637 0
Secondary outcome 2
Participant's Diary Card - Measuring urges to act on behaviours and actions taken. Also measure of emotional response. This is a composite secondary outcome.
Timepoint [2] 318637 0
Secondary outcome timepoint 2
This information is recorded by the participants on a daily basis in both programs for the duration of 8 weeks.
Secondary outcome [3] 318638 0
Secondary outcome 3
A focus group will be held at the end of both 8 week programs to assess the satisfaction rate of all participants in both groups.

The participants in the 8 week DBT skills training group with art exercises attached will also be asked the following.
What did you feel about using Creativity/art making alongside DBT Skills? Did in add value to the program Yes or No?
Timepoint [3] 318638 0
Secondary outcome timepoint 3
This satisfaction question will be conducted at the end of the week of the programs.

Eligibility
Key inclusion criteria
Participants referred to attend both 8 week programs will have a history of mental health issues specifically related to difficulty in managing or regulating emotions. They will be referred from a variety of mental health sources. They will have presented to General Practitioners, Psychiatrists or Psychologists or other mental health providers with a history of emotional dysregulation. Facilitators will be asked to complete a 'DERS' Difficulties in Emotion Regulation Scale, Gratz,K.L. & Roemer, L. (2004) with potential participants.
Minimum age
17 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for the study would be any participants exhibiting the following:
1. Marked degree of cognitive deficit which would prevent participation in essential treatment components (e.g. diary card. Specific behavioural deficits = unable to read, focus, recall, verbally communicate)
2. Actively psychotic – i.e. thought-disordered; responding to auditory hallucinations, delusional beliefs.
3. Specific behaviours: to an extent that they:
(a) Interfere with setting, being able to assess or provide treatment, or
(b) Make the individual unable to behaviourally attend/participate in assessment/treatment.
4. Using substances/alcohol – at diagnostic level of severity (such that it largely obstructs therapy)
5. Bingeing/disordered eating to point of
(a) Behaviour requiring current inpatient care and/or
(b) Inability to cope with therapy tasks

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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will attend the programs when they are scheduled to be piloted. Participants will not be given a choice as to attend 8 Week DBT Skills training program or the 8 week DBT plus art making program. Participants therefore will not necessarily have a preference for either group.

Simple randomisation using procedures like coin-tossing will be used to select participants for groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In total of 4 separate sites will be identified to conduct the pilot programs.
Two of the sites are planned to be set up in the community and the other two sites are planned to be conducted in two separate private or public hospitals outpatient settings. Approaches are currently being made to two private hospital sites.
It is envisaged that all 4 sites will conduct at least two series of both 8 weeks skills training programs.
Up to 8 Health Care Professionals will conduct the DBT only 8 Week skills based program twice.
Up to 8 other Health Care Professionals will conduct the DBT and creativity/art making 8 Week skills based program twice.
The total maximum number of facilitators will be 16. The total maximum number of co-facilitators will be 16.
There will be 8 participants in each group. A total of 128 participants for the total study

Each group will be conducted for 2.5 hours except the final group. This group will be a 3 hour group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
sample size was calculated to identify the numbers of participants required to detect an effect for outcome and process measures set at p=.05 on a two tailed repeated measures test. Standard deviations and mean outcome scores from published research using the same or similar measures in brief psychological treatment approaches were included to refine the sample size calculation. The calculation set the sample at 120 participants.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Due to family commitments
Date of first participant enrolment
Anticipated
19/02/2016
Actual
Date of last participant enrolment
Anticipated
23/03/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 4565 0
Currumbin Clinic - Currumbin
Recruitment hospital [2] 4566 0
The Sydney Clinic - Bronte

Funding & Sponsors
Funding source category [1] 292333 0
Self funded/Unfunded
Name [1] 292333 0
Megan Shiell
Country [1] 292333 0
Australia
Primary sponsor type
Individual
Name
Megan Shiell
Address
Expressive Therapy Clinic, 51 Hillcrest Avenue, TWEED HEADS SOUTH NSW 2486
Country
Australia
Secondary sponsor category [1] 291012 0
None
Name [1] 291012 0
Address [1] 291012 0
Country [1] 291012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293798 0
Institutional Human Research Ethics Committee, University of Queensland
Ethics committee address [1] 293798 0
School of Medicine
University of Queensland
288 Herston Road
Herston Qld4780
Ethics committee country [1] 293798 0
Australia
Date submitted for ethics approval [1] 293798 0
09/07/2015
Approval date [1] 293798 0
31/08/2015
Ethics approval number [1] 293798 0
2015001113

Summary
Brief summary
This research is aimed at evaluating two Dialectical Behaviour Therapy (DBT) informed skills based programs.. One Program is stand alone DBT Skills and the other DBT skills plus art making. There is a growing body of evidence that suggests DBT is a very effective treatment for many other disorders for example, addiction, depression and anxiety, eating disorders. Standard DBT comprises five approaches to assist patients. One of those approaches is a DBT Skills training group. There is also evidence that DBT Skills Training programs alone are effective in reducing impulsive behaviour and depression. (Linehan, M. 2nd Edition DBT Skills Training Manual 2015 Guilford NY).
People who suffer the symptoms of emotional dysregulation are often considered to be unpredictable, unreliable and likely to experience problems with relationships both in community, work and in their family relations.
As a Registered Art Therapist, the principal researcher has integrated creativity/art making within a standard 8 Week DBT Skills Training Program for many years. Repeated group evaluation of this approach has been positive on measures of both outcome and satisfaction with treatment. As a result the approach has now been standardised and is ready for evaluation in a clinical setting. The aims of the research are to test a DBT-Art approach along side a standard DBT control for efficacy
Outcome measures will be symptom improvement and interpersonal function and participant satisfaction with treatment.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 631 631 0 0
/AnzctrAttachments/369569-Assessment 2 Day Intensive DBT Training.docx

Contacts
Principal investigator
Name 61334 0
Mrs Megan Shiell
Address 61334 0
Expressive Therapy Clinic
51 Hillcrest Avenue,
TWEED HEADS SOUTH NSW 2486
Country 61334 0
Australia
Phone 61334 0
+61 417 084 846
Fax 61334 0
Email 61334 0
m.shiell@expressivetherapyclinic.com.au
Contact person for public queries
Name 61335 0
Mrs Megan Shiell
Address 61335 0
Expressive Therapy Clinic
51 Hillcrest Avenue
TWEED HEADS SOUTH NSW 2486
Country 61335 0
Australia
Phone 61335 0
+61 417 084 846
Fax 61335 0
Email 61335 0
m.shiell@expressivetherapyclinic.com.au
Contact person for scientific queries
Name 61336 0
Mrs Megan Shiell
Address 61336 0
Expressive Therapy Clinic
51 Hillcrest Avenue
TWEED HEADS SOUTH NSW 2486
Country 61336 0
Australia
Phone 61336 0
+61 417 084 846
Fax 61336 0
Email 61336 0
m.shiell@expressivetherapyclinic.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.