Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000320358
Ethics application status
Approved
Date submitted
23/02/2017
Date registered
28/02/2017
Date last updated
28/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Culturally modified Cognitive Processing Therapy for trauma survivors from a South-East Asian background
Scientific title
Efficacy of culturally modified cognitive processing therapy (CPT) group format for adults from a South-East Asian background with post-traumatic Stress Disorder (PTSD)
Secondary ID [1] 291259 0
none
Universal Trial Number (UTN)
U1111-1193-4393
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 302194 0
Condition category
Condition code
Mental Health 301803 301803 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this research is to examine the effectiveness of a treatment program designed to reduce posttraumatic distress (PTSD) in those who have experienced trauma and are from a South- East Asian cultural background.
Following a comprehensive clinical face-to-face assessment (1.5 hour), participants will receive twelve weekly 2 hour face-to-face group sessions of a treatment program called culturally modified Cognitive Processing Therapy (CPT-cm).
CPT Session Outline

Session 1: Symptoms of PTSD, explanation of symptoms (cognitive theory), description of therapy. Practice assignment: Write Impact Statement.

Session 2: Patient reads Impact Statement. Therapist and patient discuss meaning of trauma. Begin to identify stuck points and add to Stuck Point Log. Review symptoms of PTSD and theory. Introduction of A-B-C Worksheets with explanation of relationship among thoughts, feelings, and behaviour. Practice assignment: Complete 1 A-B-C sheet each day including at least one on the worst trauma.

Session 3: Review A-B-C practice assignment. Discuss stuck points with a focus on assimilation. Review the event with regard to any acceptance or blame issues. Begin Socratic questioning regarding stuck points. Practice assignment: Reassign A-B-C Worksheets.
Session 4: Review A-B-C practice assignment and challenge assimilation with Socratic questions. Introduce Challenging Questions Worksheet to challenge specific assimilated beliefs regarding the trauma. Practice assignment: Challenge one stuck point per day using the Challenging Questions Worksheet (focus on assimilation/blame).

Session 5: Review Challenging Questions Worksheets. Introduce Patterns of Problematic Thinking Worksheet. Practice assignment: Complete Patterns of Problematic Thinking Worksheet on a daily basis. Continue using Challenging Questions as needed. Make sure patient understands the importance of balance in beliefs rather than extreme, either/or thinking.

Session 6: Review practice assignment. Determine patterns of problematic thinking. Introduce Challenging Beliefs Worksheet. Teach patient to use the new worksheet to challenge cognitions about the trauma(s). Practice assignment: Complete Challenging Beliefs Worksheets daily on the trauma, as well as, everyday events.

Session 7: Review Challenging Beliefs Worksheets. Introduce Safety Module. Discuss how previous beliefs about safety might have been disrupted or seemingly confirmed by the index event. Use Challenging Beliefs Worksheet to challenge safety beliefs. Practice assignment: Read Safety Module and complete Challenging Beliefs Worksheets on safety.

Session 8: Review Challenging Beliefs Worksheets and help patients to challenge problematic beliefs they were unable to complete successfully on their own. Introduce Trust Module. Pick out any stuck points on self-trust or other-trust. Practice assignment: Read Trust Module and complete Challenging Beliefs Worksheets on trust.

Session 9: Review Challenging Beliefs Worksheets. Introduce Power/Control Module. Discuss how prior beliefs were affected by the trauma. Practice assignment: Read Power/Control Module and complete Challenging Beliefs Worksheets on power/control. Continue to challenge other stuck points on a daily basis using the Challenging Beliefs Worksheets.

Session 10: Review Challenging Beliefs Worksheets. Introduce module on Esteem (self-esteem and regard for others). Practice assignment: Read module and complete Challenging Beliefs Worksheets on esteem, as well as assignments regarding giving and receiving compliments and doing nice things for self. Continue to challenge other stuck points on a daily basis using the Challenging Beliefs Worksheets.

Session 11: Review Challenging Beliefs Worksheets. Discuss reactions to two behavioural assignments. Introduce final module on Intimacy. Practice assignment: Continue giving and receiving compliments, read Intimacy Module, and complete Challenging Beliefs Worksheets on stuck points regarding intimacy. Final assignment: Write final Impact Statement. Continue to challenge other stuck points on a daily basis using the Challenging Beliefs Worksheets.
Session 12: Go over all the Challenging Beliefs Worksheets. Have patient read the final Impact Statement. Read the first Impact Statement and compare the differences. Discuss any intimacy stuck points. Review the entire therapy and identify any remaining issues the patient may need to continue to work on. Encourage the patient to continue with behavioural assignments on compliments and doing nice things for self. Remind patient that she is taking over as therapist now and should continue to use skills he has learned.

Modified CPT-C
Cognitive Therapy that targets cultural differences in self and trauma-related appraisals, with focus on:
*Communion and belonging
*Connectedness – fear of alienation/isolation
*Social obligations- duty towards one’s group
*Adjustment to event
*Norm-self compatibility

*Appraisals that will be modified- appraisals derived from the interdependent aspect of self – challenging appraisals associated with the public aspects of self (I am a failure as a mother) and communal self-appraisals (such as isolation from the group and a sense of social failing)
*Re-framing and reducing the level of autonomous orientation and increasing levels of relatedness
*The impact of trauma on identity and self-definition- consideration of social roles, the impact of trauma on such social roles and the value of role complexity and diversity
*Self-consistency not as important - distress focused on social role changes (not changes to private aspects of self)
*Cultural variation in self may impact transformation of meaning –need to consider what the trauma has meant for individual’s family and other significant groups and communities to which they belong and to the relational aspects of self
Modifications are based on cross cultural research that highlights differences in self and appraisals evident in individualistic versus collectivistic cultures.
Following the 12th treatment session, participants will be asked to complete a brief assessment session. We will also contact participants 3 months following treatment to again complete a brief assessment. This will be conducted by phone.
The treatment will be conducted by a provisional psychologist and 3rd year doctoral student, who has been trained in CPT. Supervision will be provided 3 senior clinical psychologists; Dr Laura Jobson trauma and culture specialist, Dr James Courtney CPT specialist and Professor Peter Norton anxiety disorders specialist. Treatment adherence will be monitored. An interpreter will be present for all assessment and treatment sessions.
Intervention code [1] 297271 0
Treatment: Other
Comparator / control treatment
Open Trial therefore no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301268 0
proportion of participants with a reduction in trauma related symptoms assessed using Clinician-Administered PTSD Scale (CAPS) and Posttraumatic Stress Disorder Checklist (PCL-5)
Timepoint [1] 301268 0
Baseline, post treatment and 12 weeks after post treatment (CAPS)

Baseline, following each weekly treatment session, post treatment and 12 weeks after post treatment (PCL-5)
Primary outcome [2] 301269 0
Proportion of participants with reduction in PTSD related appraisals as measured by Post-traumatic Cognitions Inventory (PTCI)
Timepoint [2] 301269 0
Baseline, following the forth weekly treatment session, following the eighth weekly treatment session, post treatment and 12 weeks after post treatment
Primary outcome [3] 301270 0
Proportion of participants with reduction in symptoms of depression and anxiety as measured by the Hopkins Symptoms Checklist (HSCL-25)
Timepoint [3] 301270 0
Baseline, post treatment and 12 weeks after post treatment
Secondary outcome [1] 332159 0
A measure of self concept in terms of independent and inter interdependent self-construal’s scores as measured by the Independent and Interdependent Self Scale (IISS)
Timepoint [1] 332159 0
Baseline
Secondary outcome [2] 332160 0
Participants acculturation score (acculturation and adaptation) as measured by the Acculturation Index (AI)
Timepoint [2] 332160 0
Baseline
Secondary outcome [3] 332161 0
Participants perceived control score (degree to which participants experience perceived control with regards to a traumatic event) as measured by the Perceived Control over Stressful Events Scale (PCOSES):
Timepoint [3] 332161 0
Baseline, following the forth weekly treatment session, following the eighth weekly treatment session, post treatment and 12 weeks after post treatment
Secondary outcome [4] 332162 0
Control of internal states score as measured by the Perceived Control of Internal States Scale (PCISS)
Timepoint [4] 332162 0
Baseline, following the forth weekly treatment session, following the eighth weekly treatment session, post treatment and 12 weeks after post treatment
Secondary outcome [5] 332163 0
Primary and secondary control scores as measured by the Measurement Instrument for Primary and Secondary Control Strategies (MIDUS)
Timepoint [5] 332163 0
Baseline, following the forth weekly treatment session, following the eighth weekly treatment session, post treatment and 12 weeks after post treatment
Secondary outcome [6] 332164 0
Trauma related appraisals score as measured by the Public and Communal Self Appraisal Measure (PSCAM)
Timepoint [6] 332164 0
Baseline, following the forth weekly treatment session, following the eighth weekly treatment session, post treatment and 12 weeks after post treatment
Secondary outcome [7] 332165 0
Alcohol use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [7] 332165 0
Baseline
Secondary outcome [8] 332166 0
Drug use as measured by the Drug Abuse Screening Test (DAST)
Timepoint [8] 332166 0
Baseline
Secondary outcome [9] 332167 0
Quality of life score as measured by World Health Organization Quality of Life - brief version (WHO-QOL):
Timepoint [9] 332167 0
Baseline, post treatment and 12 weeks after post treatment
Secondary outcome [10] 332168 0
Participant perception of working alliance score as measured by the Working Alliance Inventory (WAI)
Timepoint [10] 332168 0
Post treatment
Secondary outcome [11] 332169 0
Group involvement score as measured by the Gross Cohesion Scale (GCS)
Timepoint [11] 332169 0
Baseline, following the forth weekly treatment session, following the eighth weekly treatment session and post treatment
Secondary outcome [12] 332170 0
Treatment expectancy score as measured by the Credibility Expectancy Questionnaire (CEQ)
Timepoint [12] 332170 0
Baseline
Secondary outcome [13] 332171 0
Participant satisfaction score as measured by the Client Satisfaction Questionnaire (CSQ)
Timepoint [13] 332171 0
Post treatment

Eligibility
Key inclusion criteria
Trauma survivors from a south-east Asian background with DSM-5 diagnosable PTSD as measured by the Clinician-Administered PTSD Scale (CAPS). The participant will meet DSM-5 criteria at either level:
Moderate / threshold: The respondent described a clinically significant problem. The problem satisfies the DSM-5 symptom criterion and thus counts toward a PTSD diagnosis. The problem would be a target for intervention. This rating requires a minimum frequency of 2 x month or some of the time (20-30%) PLUS a minimum intensity of Clearly Present.

Severe / markedly elevated: The respondent described a problem that is above threshold. The problem is difficult to manage and at times overwhelming, and would be a prominent target for intervention


Lived in Australia for under 5 years
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years or over 65 years., as cultural differences in the way traumatic stress is interpreted is a fairly new area of research this study will focus on the adult population. People over 65 years will be excluded to ensure that memories of more recent traumas are the focus of this study.

Less than a moderate level of PTSD symptoms

Inability to read and communicate in English sufficiently to understand and participate in assessment and treatment with English-speaking therapists and group members.

Participants undergoing current psychotherapy or who have recently started or changed medications (past 2 months).

Evidence of dementia or other neurocognitive condition that might interfere with informed consent, or understanding and participating in treatment.

Evidence of serious suicidality, current alcohol or illicit substance dependence, active psychotic symptoms or any other condition of sufficient severity that requires immediate clinical prioritisation. Should a participant respond in a way suggestive of high risk, they will be immediately referred to the level of care dictated by the risk in accordance with practice standards

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)
Not a randomised trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not a randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The treatment employed in this research is closely based upon the CPT framework, which is an empirically supported treatment for PTSD. The modifications to the treatment are based on cross cultural research. Given the limited research in this area to date, the study will be an open trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
5-9 participants are required. This is recommended according to the Cognitive Processing Therapy (CPT) group treatment guidelines.

The extent to which CPT changed PTSD symptom severity for each participant using the clinically significant change score approach will be used

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/03/2017
Actual
Date of last participant enrolment
Anticipated
17/03/2017
Actual
Date of last data collection
Anticipated
3/07/2017
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15441 0
3030 - Werribee

Funding & Sponsors
Funding source category [1] 295716 0
University
Name [1] 295716 0
Monash University
Country [1] 295716 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Psychological Sciences
Level 4, 18 Innovation Walk, Clayton, 3800
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 294562 0
None
Name [1] 294562 0
Address [1] 294562 0
Country [1] 294562 0
Other collaborator category [1] 279442 0
Charities/Societies/Foundations
Name [1] 279442 0
Action on Disability within Ethnic communities (ADEC)
Address [1] 279442 0
Level 1 1-3 Watton Street Werribee, Victoria 3030
Country [1] 279442 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297017 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 297017 0
Ethics committee country [1] 297017 0
Australia
Date submitted for ethics approval [1] 297017 0
09/02/2016
Approval date [1] 297017 0
30/03/2016
Ethics approval number [1] 297017 0
CF16/441 - 2016000207

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1518 1518 0 0
/AnzctrAttachments/372419-Ethics Approval.pdf (Ethics approval)
Attachments [2] 1519 1519 0 0
/AnzctrAttachments/372419-ADEC Consent to Treatment .doc (Participant information/consent)
Attachments [3] 1520 1520 0 0
/AnzctrAttachments/372419-Appendix B. Assessment Timeline.docx (Other)
Attachments [4] 1521 1521 0 0
/AnzctrAttachments/372419-Aim and design.docx (Participant information/consent)

Contacts
Principal investigator
Name 72734 0
Dr Laura Jobson
Address 72734 0
Monash Institute of Cognitive and Clinical Neuroscience
School of Psychological Sciences
Monash University
Level 6, Building 17, 18 Innovation Walk
Wellington Road
Clayton VIC 3800
Australia
Country 72734 0
Australia
Phone 72734 0
+61 3 99053945       
Fax 72734 0
Email 72734 0
[email protected]
Contact person for public queries
Name 72735 0
Jessica Bernardi
Address 72735 0
Monash Institute of Cognitive and Clinical Neuroscience
School of Psychological Sciences
Monash University
Level 6, Building 17, 18 Innovation Walk
Wellington Road
Clayton VIC 3800
Australia
Country 72735 0
Australia
Phone 72735 0
+61 412346293
Fax 72735 0
Email 72735 0
[email protected]
Contact person for scientific queries
Name 72736 0
Jessica Bernardi
Address 72736 0
Monash Institute of Cognitive and Clinical Neuroscience
School of Psychological Sciences
Monash University
Level 6, Building 17, 18 Innovation Walk
Wellington Road
Clayton VIC 3800
Australia
Country 72736 0
Australia
Phone 72736 0
+61 412346293
Fax 72736 0
Email 72736 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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