Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000187347
Ethics application status
Approved
Date submitted
30/01/2017
Date registered
3/02/2017
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Applying a mental health intervention to a physical health area: Is Dialectical Behaviour Therapy helpful for cancer patients
Scientific title
Applying a mental health intervention to a physical health area: Is Dialectical Behaviour Therapy helpful for cancer patients
Secondary ID [1] 290893 0
Nil
Universal Trial Number (UTN)
Trial acronym
DBT for cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 301606 0
distress 301607 0
mental health 301837 0
Condition category
Condition code
Cancer 301316 301316 0 0
Any cancer
Mental Health 301516 301516 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group psychological intervention consisting of 6 group sessions of 2 hours each delivered by a clinical Psychologist with 20 years + experience. The format of each session involves learning a skill, discussion of how to use it and practice of the skill. The skills include Distress Tolerance Skills such as distraction and self soothing and Emotional Regulation skills such as checking the facts for example taken from the skills training manual developed for Dialectical Behaviour Therapy skills training groups developed by Marsha Linehan (1993, 20013).. Sessions are face to face over a three week period twice weekly. There will be a register of sessions attended for each participant. Participants will be coached at the next session regarding any difficulties they encountered using the skills. The intervention will take place on the premises of Auckland District Health Board, Auckland New Zealand.The intervention is based on Dialectical Behaviour Therapy skills groups. Part of the research will involve using participant feedback to adapt the intervention for cancer patients.
Intervention code [1] 296838 0
Treatment: Other
Comparator / control treatment
The waitlist control group will be administered the measures at the beginning of the trial and then again 3 weeks post baseline. Following completion of the group by the initial participants and feedback via a focus group as to modifications of the material for cancer patients, those in the control group will recieve the modified DBT intervention.
Control group
Active

Outcomes
Primary outcome [1] 300724 0
Change in distress as measured by the Depression Anxiety Stress Scale (DASS-21)
Timepoint [1] 300724 0
3 weeks post baseline
Primary outcome [2] 300925 0
Change in Quality of Life as measured by The European Organisation for Research and Treatment of Cancer Quality of Life C30 Questionnaire (EORTC-C30)
Timepoint [2] 300925 0
3 weeks post baseline
Primary outcome [3] 300926 0
Change in resilience as measured by the Connor -Davidson Resilience Scale (CD-RISC)
Timepoint [3] 300926 0
3 weeks post baseline
Secondary outcome [1] 331221 0
Change in distress as measured by the Depression Anxiety Stress Scale (DASS-21)
Timepoint [1] 331221 0
6 weeks post baseline for control group
Secondary outcome [2] 331222 0
Change in Quality of Life as measured by The European Organisation for Research and Treatment of Cancer Quality of Life C30 Questionnaire (EORTC-C30)
Timepoint [2] 331222 0
6 weeks post baseline for control group
Secondary outcome [3] 331223 0
Change in resilience as measured by the Connor -Davidson Resilience Scale (CD-RISC)
Timepoint [3] 331223 0
6 weeks post baseline for control group

Eligibility
Key inclusion criteria
Inclusion criteria for participation will be 18-65 year old adults with a diagnosis of cancer who score 4 or above on the Distress Thermometer (Ransom et al., 2006), who are able to read, write and understand English and have no diagnosed psychiatric illness within the last year.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have a diagnosis of cancer and who are in current psychological treatment or counselling will be excluded from this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two way analysis of variance (ANOVA)
One way analysis of variance (ANOVA)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2017
Actual
10/04/2018
Date of last participant enrolment
Anticipated
1/09/2018
Actual
Date of last data collection
Anticipated
1/09/2018
Actual
Sample size
Target
60
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 8599 0
New Zealand
State/province [1] 8599 0
Auckland

Funding & Sponsors
Funding source category [1] 295400 0
University
Name [1] 295400 0
Auckland University of Technology
Country [1] 295400 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Faculty of Health and Environmental Science
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 294222 0
None
Name [1] 294222 0
None
Address [1] 294222 0
None
Country [1] 294222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296733 0
Central Committee
Ethics committee address [1] 296733 0
Ethics committee country [1] 296733 0
New Zealand
Date submitted for ethics approval [1] 296733 0
09/02/2017
Approval date [1] 296733 0
05/05/2017
Ethics approval number [1] 296733 0

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

Contacts
Principal investigator
Name 71646 0
Dr Kirk D. Reed
Address 71646 0
Auckland University of Technology
Mail Code A11
Private Bag 92006
Auckland
Country 71646 0
New Zealand
Phone 71646 0
+6499219136
Fax 71646 0
Email 71646 0
[email protected]
Contact person for public queries
Name 71647 0
Patricia (Trish) Du Villier
Address 71647 0
Auckland District Health Board
Taylor Centre
308 Ponsonby Road, Auckland 1011
Country 71647 0
New Zealand
Phone 71647 0
+6421620044
Fax 71647 0
Email 71647 0
[email protected]
Contact person for scientific queries
Name 71648 0
Patricia (Trish) Du Villier
Address 71648 0
Auckland District Health Board
Taylor Centre
308 Ponsonby Road, Auckland 1011
Country 71648 0
New Zealand
Phone 71648 0
+6421620044
Fax 71648 0
Email 71648 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.