Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000585628
Ethics application status
Approved
Date submitted
27/05/2014
Date registered
2/06/2014
Date last updated
29/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Acceptance and Commitment Therapy based group treatment for trauma symptom management and overall wellbeing in a residential Alcohol and Other Drug treatment facility.
Scientific title
The efficacy of trauma symptom management group-work for reducing trauma symptoms and improving wellbeing, in clients accessing treatment in a residential Alcohol and Other Drug treatment facility.
Secondary ID [1] 284667 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 291994 0
Alcohol and Other Drug Dependence 291995 0
Condition category
Condition code
Mental Health 292339 292339 0 0
Other mental health disorders
Mental Health 292340 292340 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clients in a residential Alcohol and Other Drug (AOD) treatment facility will attend 8 x 1 hour sessions of Acceptance and Commitment Therapy group work over 8 weeks. The treatment will be trialled on 3 separate groups of clients over 12 months.
Sessions will include psychoeducation on the causes and effects of trauma. Acceptance and Commitment Therapy will be utilised to teach clients appropriate techniques of symptom management. Efficacy will be determined by a reduction in trauma symptoms according to the PTSD Symptom Checklist, and an improvement in wellbeing based in the EUROHIS Quality of Life 8 Item Index. Improvements in psychological distress are also expected, as measured by the Kessler 10 Psychological Distress Scale.
Intervention code [1] 289446 0
Behaviour
Intervention code [2] 289485 0
Treatment: Other
Comparator / control treatment
Clients will first undergo treatment as usual for 8 weeks in a residential AOD treatment facility. PTSD symptoms, wellbeing, and psychological distress will be measured in clients during this 8 week period.

Acceptance and Commitment Therapy based groupwork will then be integrated into treatment. This groupwork will relate to PTSD and trauma. Outcomes following 8 weeks of ACT groupwork will be compared to outcomes following 8 weeks of treatment as usual. All clients will therefore receive treatment as usual, in addition to the ACT group-work.
Control group
Historical

Outcomes
Primary outcome [1] 292203 0
A reduction in PTSD symptoms, based on the PTSD Symptom Checklist for Civilians (PCL-C).
Timepoint [1] 292203 0
Baseline: Calculated by averaging weekly measurements for two months of AOD treatment as usual, until commencing the proposed treatment.
One week following treatment, and at one month follow up.
Primary outcome [2] 292209 0
Wellbeing, measured by the World Health Organisation 8-point Quality of Life Scale (EUROHIS-QOL 8)
Timepoint [2] 292209 0
Baseline: Calculated by averaging weekly measurements for two months of AOD treatment as usual, until commencing the proposed treatment.
One week following treatment, and at one month follow up.
Primary outcome [3] 292215 0
Psychological Distress as measured by the Kessler Psychological Distress Scale (K10+)
Timepoint [3] 292215 0
Baseline: Calculated by averaging weekly measurements for two months of AOD treatment as usual, until commencing the proposed treatment.
One week following treatment, and at one month follow up.
Secondary outcome [1] 308406 0
nil
Timepoint [1] 308406 0
nil

Eligibility
Key inclusion criteria
All current clients at We Help Ourselves (WHOS) 'New Beginnings' women's AOD treatment program.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Mental health screenings are carried out as standard practise at New Beginnings to determine eligibility for treatment. Prescreening questionnaires include a severity of dependence scale, frequency and pattern of drug and alcohol use based on the BTOM and ATTOM, Kessler 10, and WHO QoL-8 Quality of life scale.
Women are not eligible for admission to New Beginnings if they demonstrate florid psychosis, risk of suicide, or if their mental health is deemed too unstable by our mental health nurse.

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)
All participants will be enrolled in the treatment condition. All participants will complete 8 weeks of treatment as usual to be used as a baseline measure. All participants will then complete 8 weeks of the proposed treatment in addition to treatment as usual.
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 design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/06/2014
Actual
14/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289298 0
Other
Name [1] 289298 0
Network of Alcohol and other Drugs Agencies (NADA)
Country [1] 289298 0
Australia
Primary sponsor type
Other
Name
Network of Alcohol and other Drugs Agencies (NADA)
Address
PO Box 2345
Strawberry Hills
NSW 2012
Country
Australia
Secondary sponsor category [1] 287968 0
None
Name [1] 287968 0
Address [1] 287968 0
Country [1] 287968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291062 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 291062 0
UNSW Research Ethics & Compliance Support

Level 3, Rupert Myers Building (South)

The University of New South Wales

Sydney NSW 2052
Ethics committee country [1] 291062 0
Australia
Date submitted for ethics approval [1] 291062 0
30/05/2014
Approval date [1] 291062 0
09/07/2014
Ethics approval number [1] 291062 0
HC14173

Summary
Brief summary
A group-based positive mental health and PTSD symptom management program will be implemented into a residential Alcohol and Other Drug treatment facility. Clients will receive education on the causes and effects of trauma, and will be taught trauma symptom management strategies using an Acceptance and Commitment Therapy approach. The aim is to keep clients in treatment and support them with PTSD symptom management strategies until they can access specialist services post treatment. The evaluation of the project will involve a number of formal assessments as well as retention and self-report data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48690 0
Ms Jo Lunn
Address 48690 0
We Help Ourselves, PO Box 1779, Rozelle NSW 2039
Country 48690 0
Australia
Phone 48690 0
+61 2 4225 7492
Fax 48690 0
Email 48690 0
jo.lunn@bigpond.com
Contact person for public queries
Name 48691 0
Ms Jo Lunn
Address 48691 0
We Help Ourselves, PO Box 1779, Rozelle NSW 2039
Country 48691 0
Australia
Phone 48691 0
+61 2 4225 7492
Fax 48691 0
Email 48691 0
jo.lunn@bigpond.com
Contact person for scientific queries
Name 48692 0
Ms Jo Lunn
Address 48692 0
We Help Ourselves, PO Box 1779, Rozelle NSW 2039
Country 48692 0
Australia
Phone 48692 0
+61 2 4225 7492
Fax 48692 0
Email 48692 0
jo.lunn@bigpond.com

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.