Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001041448
Ethics application status
Approved
Date submitted
19/07/2016
Date registered
4/08/2016
Date last updated
18/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Group-Based Compassion-Focused Therapy Program in Reducing Trauma-Related Symptoms for Adult Female Survivors of Sexual Assault.
Scientific title
Effectiveness of Group-Based Compassion-Focused Therapy Program in Reducing Trauma-Related Symptoms for Adult Female Survivors of Sexual Assault.
Secondary ID [1] 289706 0
None
Universal Trial Number (UTN)
Trial acronym
CFT-SA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress 299519 0
Condition category
Condition code
Mental Health 299497 299497 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study will develop and test a group-based intervention for adult female survivors of sexual assault utilising the underlying framework and core skills and techniques of Compassion-Focused Therapy (CFT). CFT has been developed by Paul Gilbert to assist clients to cultivate self-compassion as an antidote to high levels of shame and self-criticism. It includes the development of core compassion-based attributes such as care for well-being, sensitivity, sympathy, distress tolerance, empathy, and non-judgement/acceptance, all underpinned by an emotional tone of warmth. Specific skills utilised in CFT to develop these attributes are compassionate imagery, compassionate attention, compassionate feeling, sensory focusing, compassionate behaviour, and compassionate thinking/reasoning.
An 8 week x 2 hr group program will be developed based on these core CFT skills and attributes, specifically adapted for the needs of the target group (adult female sexual assault survivors). Participants will be recruited from specialised sexual assault services within Queensland. The study will consist of 4 stages: 1) focus group discussions with sexual assault survivors and counsellors who work with them, in relation to their experience and understanding of self-compassion and related concepts, 2) development and pilot of Compassion-Focused Therapy for Sexual Assault (CFT-SA) group program which will be trialled with approximately 8-10 participants over an 8 week period, with 2 hour sessions per week, 3) training of other sexual assault counsellors to facilitate the program, and 4) delivery of the program and measuring effectiveness against a control group.
The focus group discussions, development and delivery of the pilot group program, and development and delivery of the training modules, will be undertaken by the principal investigator, who is a registered psychologist with significant experience working in the area of abuse and trauma, with specialist knowledge in sexual assault. Stage 4 of the study will include other suitably trained and experienced (minimum 5 years) sexual assault counsellors in facilitation of the program.
The specific content of the CFT-SA group program has not yet been developed as it will be partially informed by information obtained in stage 1 of the project (focus group discussions). Similarly, the specific content of the training structure or content for other counsellors is not yet fully developed as it will be determined by the content of the program. It is anticipated that stage 4 of the trial will also involve 8 x weekly 2 hour group sessions, with a comparable control group format. However final determination of the content and structure of the program will be largely influenced by outcomes from the pilot program in stage 2. Trial information will be updated once these details are known.
Intervention code [1] 295333 0
Treatment: Other
Intervention code [2] 295509 0
Behaviour
Comparator / control treatment
The first 3 stages of the study will not involve a control group. The 4th stage will compare the CFT-SA program against other general support group-based programs with the same target population (i.e. adult female survivors of sexual assault). Specific details of the control group are not yet known but the trial record will be updated when this information is available.
Allocation to experimental or control group will not be randomised as groups are likely to be offered, and data gathered, across geographically diverse sites (sexual assault services), with some sites only offering either control or experimental group, eliminating the option for randomised allocation to one or the other. Additionally, even in the event that such an option is available, this approach may contradict the principles of informed choice, empowerment, and client control over their participation in service options, which is central to the philosophy of sexual assault services.
Control group
Active

Outcomes
Primary outcome [1] 298977 0
Proportion of participants with reduction in post-traumatic stress symptoms, as measured by PTSD Checklist for DSM-5 (PCL-5, Weathers et al., 2013).
Timepoint [1] 298977 0
Pre-measures will be administered within 2 weeks of commencement of group program, and post-measures will be administered in final session of 8-week program.
Primary outcome [2] 299153 0
Proportion of participants with increase in self-compassion as measured by Self-Compassion Scale (Neff, 2003)
Timepoint [2] 299153 0
Pre-measures will be administered within 2 weeks of commencement of group program, and post-measures will be administered in final session of 8-week program.
Primary outcome [3] 299154 0
Proportion of participants with reduction in external shame as measured by Other as Shamer Scale (Gilbert, Allan, & Goss, 1994)
Timepoint [3] 299154 0
Pre-measures will be administered within 2 weeks of commencement of group program, and post-measures will be administered in final session of 8-week program.
Secondary outcome [1] 325811 0
Proportion of participants with reductions in negative and self-critical thoughts and feelings as measured by The Forms of Self-Criticising/Attacking & Self-Reassuring Scale (FSCRS, Gilbert et al., 2004)
Timepoint [1] 325811 0
All measures will be administered within 2 weeks pre- group commencement, and in final session of 8 week group program.
Secondary outcome [2] 326345 0
Proportion of participants with reduction in Fear of Compassion, as measured by Fear of Compassion Scale (Gilbert et al., 2011).
Timepoint [2] 326345 0
Pre-measures will be administered within 2 weeks of commencement of group program, and post-measures will be administered in final session of 8-week program.
Secondary outcome [3] 326347 0
Proportion of participants with reduction in symptoms of depression, as measured by Depression, Anxiety, and Stress Scale (DASS21, Lovibond & Lovibond, 1995).
Timepoint [3] 326347 0
Pre-measures will be administered within 2 weeks of commencement of group program, and post-measures will be administered in final session of 8-week program.
Secondary outcome [4] 326348 0
Proportion of participants with reduction in symptoms of anxiety, as measured by Depression, Anxiety, and Stress Scale (DASS21, Lovibond & Lovibond, 1995).
Timepoint [4] 326348 0
Pre-measures will be administered within 2 weeks of commencement of group program, and post-measures will be administered in final session of 8-week program.
Secondary outcome [5] 326349 0
Proportion of participants with reduction in symptoms of stress, as measured by Depression, Anxiety, and Stress Scale (DASS21, Lovibond & Lovibond, 1995).
Timepoint [5] 326349 0
Pre-measures will be administered within 2 weeks of commencement of group program, and post-measures will be administered in final session of 8-week program.

Eligibility
Key inclusion criteria
Participants have experienced at least one self-reported incident of sexual abuse in either childhood or adulthood (or both), and are self-reporting some level of functional distress as a result of this experience.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute sexual assault experience; current suicidality; untreated psychosis; current substance addiction; as well as any other issue that will significantly interfere with group dynamics or be detrimental of the participants well-being (as assessed by Principal Investigator in consultation with client (participant) and client's counsellor).

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study is non-randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Only stage 4 of the current study will involve a control group. Stage 1 is focus group discussions, stage 2 is development and piloting of group program, and stage 3 is training other sexual assault counsellors in delivery of the program. Stage 4 will compare CFT-SA program to other existing support groups (without a Compassion-Focused Therapy focus) of similar duration consistently offered within sexual assault services.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
3/10/2016
Actual
3/10/2016
Date of last participant enrolment
Anticipated
Actual
17/07/2017
Date of last data collection
Anticipated
5/09/2017
Actual
Sample size
Target
80
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294087 0
University
Name [1] 294087 0
University of Queensland
Country [1] 294087 0
Australia
Funding source category [2] 294213 0
Other
Name [2] 294213 0
Laurel Place Inc (Sexual Assault Service)
Country [2] 294213 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, Qld, 4072
Country
Australia
Secondary sponsor category [1] 292919 0
None
Name [1] 292919 0
Laurel Place Inc Sexual Assault Service
Address [1] 292919 0
P O Box 384
COTTON TREE, QLD, 4558
Country [1] 292919 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295503 0
Bellberry Limited
Ethics committee address [1] 295503 0
Ethics committee country [1] 295503 0
Australia
Date submitted for ethics approval [1] 295503 0
19/07/2016
Approval date [1] 295503 0
24/08/2016
Ethics approval number [1] 295503 0

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

Contacts
Principal investigator
Name 67510 0
Ms Lisa McLean
Address 67510 0
c/- Laurel Place, P O Box 384, COTTON TREE, QLD, 4558
Country 67510 0
Australia
Phone 67510 0
+61 7 54434711
Fax 67510 0
Email 67510 0
[email protected]
Contact person for public queries
Name 67511 0
Lisa McLean
Address 67511 0
c/- Laurel Place, P O Box 384, COTTON TREE, 4558
Country 67511 0
Australia
Phone 67511 0
+61 7 54434711
Fax 67511 0
Email 67511 0
[email protected]
Contact person for scientific queries
Name 67512 0
Lisa McLean
Address 67512 0
c/- Laurel Place, P O Box 384, COTTON TREE, QLD, 4558
Country 67512 0
Australia
Phone 67512 0
+61 7 54434711
Fax 67512 0
Email 67512 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
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