ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Posttraumatic Stress Disorder

Condition category

Condition code

Mental Health

Addiction

Mental Health

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]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Symptom severity of Posttraumatic Stress Disorder as measured by the PTSD Checklist for the DSM-5

Timepoint [1]

Baseline and 1 (primary endpoint), 3, and 6 months follow-up post-intervention.

Secondary outcome [1]

Level of substance use and related problems through a composite score on the Alcohol, Smoking and Substances Involvement Screening Test (WHO ASSIST)

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee

Ethics committee address [1]

Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/07/2020

Ethics approval number [1]

#2020000949

Summary

Brief summary

This study seeks to determine the feasibility of Cognitive Processing Therapy for young people with Posttraumatic Stress Disorder (PTSD) receiving care in residential treatment for substance use disorder (SUD). Research has demonstrated symptom reduction for both disorders when treatment for PTSD and comorbid SUD is integrated (Brown, Stout, & Gannon-Rowley, 1998; Najavits, Sullivan, Schmitz, Weiss, & Lee, 2004; Roberts, Roberts, Jones, & Bisson, 2015; Watts et al., 2013). CPT is considered a ‘gold-standard’ treatment for PTSD, and has been shown to be more efficacious than other evidence-based treatments such as exposure-based interventions (Asmundson et al., 2019; Holliday, Holder, & Surís, 2018; Lenz, Bruijn, Serman, & Bailey, 2014; Roberts et al., 2015). Despite this, trials of CPT for PTSD with comorbid SUD has generally been restricted to adult and veteran samples from the U.S. (Kaysen et al., 2014; Pearson, Kaysen, Huh, & Bedard-Gilligan, 2019), which include people with a high proportion of substance misuse, but not individuals with PTSD and concurrent SUD exclusively. Residential treatment for Alcohol and Other Drug (AOD) use may provide a safe environment to deliver PTSD therapy and reduce drop-out rates, as they offer ongoing mental health and AOD recovery support which PTSD and SUD diagnosed individuals may not otherwise have access to (Pearson et al., 2019; Reif et al., 2014). However, the feasibility of integrated PTSD/SUD treatment within the residential AOD environment and the effectiveness of integrated CPT for comorbid PTSD/SUD for young people is not yet established. 

We plan to determine the preliminary feasibility of CPT for PTSD/SUD in the residential AOD setting through an uncontrolled feasibility trial. Our sample size goal is 50 participants. Mean differences will be examined from pre-to-post baseline and at 3 and 6 month follow-up time points.  The study will allow a better understanding of the effectiveness of CPT for PTSD and as a novel intervention for SUD. The findings of this study will additionally inform the mechanisms of change in CPT, and why some individuals with PTSD/SUD (and other comorbidities) may have a better treatment response to CPT .

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss Valeriya Mefodeva

Address

Rm 303
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 478290118

Fax

v.mefodeva@uq.edu.au

Contact person for public queries

Name

Valeriya Mefodeva

Address

Rm 303
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 478290118

Fax

v.mefodeva@uq.edu.au

Contact person for scientific queries

Name

Valeriya Mefodeva

Address

Rm 303
School of Psychology
McElwain Building
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 478290118

Fax

v.mefodeva@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically