Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000296831
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
18/03/2021
Date last updated
23/02/2022
Date data sharing statement initially provided
18/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of Cognitive Processing Therapy for young people with comorbid Substance Use and Posttraumatic Stress Disorders in residential substance use treatment
Scientific title
Pilot feasibility study on the effect of Cognitive Processing Therapy on the severity of Posttraumatic Stress and comorbid Substance Use Disorder symptoms for young people in residential substance use treatment
Secondary ID [1] 303435 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CPT for SUD and PTSD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance Use Disorder 320739 0
Posttraumatic Stress Disorder 320740 0
Condition category
Condition code
Mental Health 318577 318577 0 0
Addiction
Mental Health 318578 318578 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters (Resick et al., 2016). CPT will be delivered by a trained clinician (provisional psychologist supervised by a board-approved, endorsed clinical psychologist) on an individual, twice-weekly basis, over 6-8 weeks, with 90-minute sessions. Sessions are delivered through both telehealth (video) and in-person delivery.

Session 1 -
The goals for the first session of CPT are to engage the client in treatment and provide psychoeducation on the relationship between PTSD and AOD use. The therapist also explains the rationale behind CPT: giving client’s tools to examine their thoughts and emotions, feeling the natural emotions arising from the trauma, and changing thoughts around trauma that are keeping client’s stuck (referred to as stuck points in CPT).

Sessions 2-3 -
Sessions 2-3 will focus on identifying stuck points that have interfered with the client’s recovery after their trauma(s), including the role of AOD use. These sessions are foundational to developing the client’s association between thoughts and feelings and the client is taught to identify and self-monitor these associations.

Sessions 4- 5 -
The goal for these sessions are for the client to be able to label events, thoughts, and emotions and to understand the connections among them. These sessions will also introduce categorising thoughts objectively as well as challenging the client’s individual thoughts that can be related to the trauma or AOD use behaviour.

Sessions 6-7 -
The first goal of sessions 6 and 7 are to teach the clients to become their own cognitive therapists. Secondly, the clients are asked to identify their patterns of problematic thinking in relation to the traumatic event(s) and AOD use.

Sessions 8-10 -
The primary goals of sessions 8-10 is to examine the themes of Safety, Trust, Power, and Control related to the traumatic event. In addition, the client and therapist continue to integrate any unresolved ‘stuck points’ relevant to the index trauma.

The session structure over the 6-8 period is as follows:
Sessions 1 and 2 - Week 1
Sessions 2 and 3 - Week 2
Sessions 4 and 5 - Week 3
Sessions 6 and 7 - Week 4
Sessions 8 and 9 - Week 5
Session 10 - Week 6

The sessions are to be delivered throughout six weeks given participants attend the twice-weekly session structure. An extension to eight weeks is provided for participants who miss sessions within the six-week time period.

Treatment fidelity of the intervention will be monitored through: a) de-identified audio recordings which will be assessed at the end of treatment by independent CPT clinicians, b) session checklists for clinicians during sessions, and c) weekly supervision of clinicians by a trained, board-approved clinical supervisor specializing in the delivery of CPT.
Intervention code [1] 319738 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326537 0
Symptom severity of Posttraumatic Stress Disorder as measured by the PTSD Checklist for the DSM-5
Timepoint [1] 326537 0
Baseline and 1 (primary endpoint), 3, and 6 months follow-up post-intervention.
Secondary outcome [1] 391802 0
Level of substance use and related problems through a composite score on the Alcohol, Smoking and Substances Involvement Screening Test (WHO ASSIST)
Timepoint [1] 391802 0
Baseline and 1, 3 (follow-up), and 6 (follow-up) months post-intervention completion.

Eligibility
Key inclusion criteria
Clients attending Lives Lived Well services with a provisional DSM-5 Diagnosis of PTSD on the PTSD Checklist (PCL-5) may be offered CPT (a score of 31+ or 26+ for sub-threshold symptoms). The PCL-5 is a measure used to assess PTSD symptomatology based on the DSM-5 criteria. This requires the client to need at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20) on the PCL-5.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Following CPT protocol recommendations (Resick et al., 2016), participants will be excluded from therapy if they meet any of the following:
a) non-fluent in English
b) acutely suicidal
c) current diagnosis of schizophrenia, currently manic bipolar, or intellectual disability
d) Experienced a trauma that had occurred before the age of three (as there is an inability to remember the trauma)

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mean differences in scores from pre-to-post baseline and at three and six month follow-up will be analysed (utilising t-tests and/or within-subject ANOVAs). Individual and group differences between weekly scores will also be examined.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/02/2021
Date of last participant enrolment
Anticipated
25/02/2022
Actual
21/10/2021
Date of last data collection
Anticipated
25/02/2022
Actual
21/10/2021
Sample size
Target
50
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 307856 0
Government body
Name [1] 307856 0
National Health and Medical Research Council (NHMRC)
Country [1] 307856 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 308603 0
None
Name [1] 308603 0
None
Address [1] 308603 0
None
Country [1] 308603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307860 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 307860 0
Ethics committee country [1] 307860 0
Australia
Date submitted for ethics approval [1] 307860 0
Approval date [1] 307860 0
09/07/2020
Ethics approval number [1] 307860 0
#2020000949

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

Contacts
Principal investigator
Name 108730 0
Miss Valeriya Mefodeva
Address 108730 0
Rm 303
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 108730 0
Australia
Phone 108730 0
+61 478290118
Fax 108730 0
Email 108730 0
[email protected]
Contact person for public queries
Name 108731 0
Valeriya Mefodeva
Address 108731 0
Rm 303
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 108731 0
Australia
Phone 108731 0
+61 478290118
Fax 108731 0
Email 108731 0
[email protected]
Contact person for scientific queries
Name 108732 0
Valeriya Mefodeva
Address 108732 0
Rm 303
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072
Country 108732 0
Australia
Phone 108732 0
+61 478290118
Fax 108732 0
Email 108732 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 identifiable data will be available for public viewing.


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.