Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001304325
Ethics application status
Approved
Date submitted
5/09/2017
Date registered
12/09/2017
Date last updated
22/01/2020
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
iDBT: Online Dialectical Behaviour Therapy Inspired Skills-Only Training for Emotional Dysregulation in Young People (18-25years).
Scientific title
The 'iDBT' Program: A Pilot Intervention to evaluate the effect of Dialectical Behaviour Therapy (DBT) on maladaptive coping and emotion regulation behaviours in young people (18-25 years) identified as having engaged in or currently engaging in at-risk coping behaviours.
Secondary ID [1] 292811 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maladaptive coping behaviours
 304629 0
Emotion dysregulation
 304664 0
Risk taking behaviours 304665 0
Condition category
Condition code
Mental Health 303949 303949 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be three groups:
Group 1 (G8: TAU + 8 week online) 1 session a week
Baseline measure (2 weeks pre)
Pre-test Measures (start program)
Program delivery (8 weeks - 1 module a week - Weekly DERS-SF)
Post-test Measures
Follow-up measures (8 weeks post)

Group 2 (G4: TAU + 4 week online) 2 sessions a week
Baseline measure (2 weeks pre)
Pre-test Measures (start program)
Program delivery (4 weeks - 2 modules a week - Weekly DERS-SF)
Post-test Measures
Follow-up measures (4 weeks post)

Participants will be asked to log on to the website to complete the skills and tasks set for each module. It is anticipated that each module should take approximately 40-50 minutes to complete.

iDBT program

Module 1
Introduction
Safety plan
The DBT coping skills box
• What is DBT?
• The development of DBT
• What skills are taught in DBT?
• What does "dialectical" mean?
• Philosophy and principles of DBT
Core mindfulness
Reasonable mind
Emotion mind
Wise mind
What skills
How skills
- mindfulness activity

Module 2: Distress Tolerance
Introduction
Crisis survival skills
Stop skill
Changing your body chemistry
Distract with accepts
Distract with self-soothe
Mindfulness activity

Module 3: Distress Tolerance

Introduction
Improve the moment
Pros and cons
Radical acceptance
mindfulness activity
Turning the mind
Half smile
Willing hands

Module 4: Emotional Regulation
Emotions
The ‘wave’ skill (being mindful of emotions)
Check the facts
Changing emotions
Problem solving
Acting opposite
mindfulness activity

Module 5: Emotional Regulation

Values
Increasing positive emotions
Mindfulness activity
Build mastery & cope ahead
Please master
Sleep
Self-care plan
Mindfulness activity

Module 6: Interpersonal Effectiveness
Interpersonal effectiveness
Dear man
Mindfulness activity

Give
Mindfulness activity

Module 7: Interpersonal Effectiveness
Introduction
Fast
Evaluating options
Troubleshooting
Mindfulness activity
Relationships
Validation
Cheerleading statements
Mindfulness activity

Module 8: walking the middle path – review & closing
Introduction
Dialectics/dialectical dilemmas
Behaviouralism
Mindfulness activity
Recap the last seven weeks
Intervention code [1] 299059 0
Early detection / Screening
Intervention code [2] 299060 0
Prevention
Intervention code [3] 299061 0
Treatment: Other
Comparator / control treatment
Group 3 (GW: Waitlist control = TAU for 4 weeks followed by online 4 weeks - 2 sessions a week)
Baseline measure (2 weeks pre)
Pre-test Measures (start program)
TAU* 4 week (Weekly DERS-SF)
Mid measures taken
Online program delivery (4 weeks - 2 modules a week - Weekly DERS-SF)
Post-test Measures
Follow-up measures (4 weeks post)
This group will complete the same online program as the other two groups.
*TAU will include the normal monitoring and support given to clients in the service. this may include follow up phone calls and single session interim support which has a psychoeducational Cognitive Behaviour Therapy framework.
Control group
Active

Outcomes
Primary outcome [1] 303296 0
emotional dysregulation as assessed by Difficulties in Emotional Regulation Scale-Short Form and Modified Affective Control Scale-18
Timepoint [1] 303296 0
Baseline, weekly, after intervention commencement, and follow up 4 weeks later
Secondary outcome [1] 338548 0
Depressive symptomatology assessed by the Beck Depression Inventory.
Timepoint [1] 338548 0
Baseline, midpoint, after intervention commencement, and follow up 4 weeks later
Secondary outcome [2] 338549 0
Anxiety related behaviours assessed by the Beck Anxiety Inventory.
Timepoint [2] 338549 0
Baseline, midpoint, after intervention commencement, and follow up 4 weeks later

Eligibility
Key inclusion criteria
Be between the ages of 18 and 25 years
Have regular access to an Internet connected device (e.g. smart phone, iPad).
Currently live in Perth.
Need some assistance in coping skills and emotion regulation.
Be willing to engage and commit to the program.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not involved in similar programs
Has an intellectual disability or major mental health issues.
Experiencing current suicidal ideation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
participants will be allocated to a condition 1, 2, or 3, in the order they are recruited
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be assigned to one of the three conditions. All participants will receive the same intervention over varying time frames and intensity (number of sessions a week)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
there will be a total of 45 participants.
participant responses will be analysed using a split-plot ANOVA, to test for changes in test scores from pre, to post, and at follow-up, and for group comparisons. Analysis will also include: measures of reliability and validity, convergent and discriminant validity. The dependent variable will be emotional dysregulation. To measure the effectiveness of the program, analysis will be conducted on the dependent variable between measurement at the initial baseline, post the program, and at follow-up. To measure the effect of intensity and duration, comparison between the groups will be analysed. Attention will also be paid to clinically relevant indicators of change.

If there is considerable missing data a data imputation to estimate missing values will be utilised to estimate missing data that is missing at random. If missing data is substantial and it cannot imputed then a Generalised Linear Model (GLM) approach will be considered, where the treatment groups would be included in the model as random slopes

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/01/2018
Actual
24/01/2018
Date of last participant enrolment
Anticipated
31/01/2019
Actual
31/12/2018
Date of last data collection
Anticipated
10/01/2020
Actual
Sample size
Target
45
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 297441 0
University
Name [1] 297441 0
Murdoch University
Country [1] 297441 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
Dr Suzanne Dziurawiec
Murdoch University
School of Psychology and Exercise Science
Murdoch University South Street,
MURDOCH WA 6150
Country
Australia
Secondary sponsor category [1] 296438 0
None
Name [1] 296438 0
Address [1] 296438 0
Country [1] 296438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298550 0
Murdoch University Human Research Ethics Committee (HREC)
Ethics committee address [1] 298550 0
Ethics committee country [1] 298550 0
Australia
Date submitted for ethics approval [1] 298550 0
31/08/2017
Approval date [1] 298550 0
28/11/2017
Ethics approval number [1] 298550 0
2017/164

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77430 0
Ms Shannon Butler
Address 77430 0
Murdoch University
School of Psychology and Exercise Science
Murdoch University South Street,
MURDOCH WA 6150
Country 77430 0
Australia
Phone 77430 0
+61 403 303 492
Fax 77430 0
Email 77430 0
[email protected]
Contact person for public queries
Name 77431 0
Shannon Butler
Address 77431 0
Murdoch University
School of Psychology and Exercise Science
Murdoch University South Street,
MURDOCH WA 6150
Country 77431 0
Australia
Phone 77431 0
+61 403 303 492
Fax 77431 0
Email 77431 0
[email protected]
Contact person for scientific queries
Name 77432 0
Shannon Butler
Address 77432 0
Murdoch University
School of Psychology and Exercise Science
Murdoch University South Street,
MURDOCH WA 6150
Country 77432 0
Australia
Phone 77432 0
+61 403 303 492
Fax 77432 0
Email 77432 0
[email protected]

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


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.