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Trial registered on ANZCTR


Registration number
ACTRN12622001099718
Ethics application status
Approved
Date submitted
2/08/2022
Date registered
9/08/2022
Date last updated
13/04/2024
Date data sharing statement initially provided
9/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Guided Self-Help using Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Controlled Trial
Scientific title
Effectiveness of Guided Self-Help using Cognitive Processing Therapy on Symptom Severity in Posttraumatic Stress Disorder: A Randomized Controlled Trial
Secondary ID [1] 307510 0
None
Universal Trial Number (UTN)
Trial acronym
CPT-GSH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder (PTSD) 326938 0
Condition category
Condition code
Mental Health 324124 324124 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
My study will test an online version of guided self-help cognitive processing therapy (from here on labelled CPT-GSH) with modest therapist input for monitoring and support for treating posttraumatic stress disorder in adults. This will be the first study to assess the CPT-GSH in a stepped care model.

The participants who meet the eligibility criteria will be randomly allocated to either a standard CPT or stepped care (CPT-GSH) group.

Standard CPT:
CPT is an evidence-based treatment for PTSD. It helps clients to challenge and modify their distressing thoughts relating to the traumatic event. CPT session begins with psychoeducation about PTSD symptoms and overall treatment goals. In the subsequent sessions, the participant will be taught to identify stuck points related to their thoughts and feelings and complete worksheets weekly. In addition, the therapist will also focus on specific topics such as safety, trust, power or control, esteem, and intimacy which are drastically affected for a trauma survivor. Typically, standard CPT comprises of 60-min weekly session which could be tailored to 8 to 18 sessions based on participant’s progress, which is determined by the therapist and client (taking into account consultation with the supervisor). In this study, CPT will be delivered one-on-one via video call. All therapy sessions will be videotaped for the purpose of the study.

Stepped care :
In the stepped care condition, participants will be enrolled into CPT-GSH and can be stepped up to a standard CPT. CPT-GSH is an adapted and modified version of self-help manual created by Resick et al. (in prep). CPT-GSH follows the same protocol of standard CPT (including the content) mentioned above except that the therapist input will be minimal. Participants will be required to read one module every week (for up to 12 sessions) sent by the study team and complete worksheets (e.g. challenging thoughts, challenging beliefs, problematic thinking worksheets, etc.) on their own. Approximately, participants need to spend about an hour to complete their modules. If participants show significant improvement in their PTSD scores, then two modules will be sent weekly. Completed assignments will be sent back to the therapist for review. Therapists will engage with clients for a maximum of 15 minutes weekly to provide support and feedback to monitor adherence and maintain their engagement in therapy. Participants can be stepped up to a standard CPT if a) there is minimal improvement; b) they are at risk of dropout; c) they demonstrate lack of engagement early in therapy; d) they show significant increase in symptom manifestation that requires more intensive therapy. Decision to be stepped up is determined by the therapist and client (after consultation with the supervisor).

All therapy sessions in both groups will be conducted by registered/ provisional psychologists. The total number of sessions in both groups is flexible based on participants’ progress in the study, although it is capped at 18 sessions.

Once the participants conclude the therapy, they will complete the post-treatment questionnaires two weeks after completion of the study . They will be assessed again in 3 months using the follow-up assessment batteries. Although subject to further funding, participants will be asked (in the Information and Consent forms) if they are willing to participate in 6 month- and 1-year follow-ups should funding/further resources become available
Intervention code [1] 323973 0
Treatment: Other
Comparator / control treatment
The standard CPT is used as the comparison treatment. CPT is an evidence-based treatment for PTSD, consisting of twelve 60-min session which could be tailored to 8 to 18 sessions based on client’s progress.
Control group
Active

Outcomes
Primary outcome [1] 331932 0
PTSD symptom severity as measured on the Clinician Administered PTSD Scale (CAPS)
Timepoint [1] 331932 0
It will be administered at baseline, post-treatment (two weeks after the completion of the study) (primary endpoint), and 3-month post-intervention completion (primary endpoint) to assess for change in PTSD symptoms.
Primary outcome [2] 331933 0
PTSD symptom severity as measured on the Posttraumatic Stress Disorder Checklist (PCL-5)
Timepoint [2] 331933 0
It will be administered weekly for the duration of treatment and at baseline, post-treatment (two weeks after the completion of the study)(primary endpoint), and 3-month post-intervention completion (primary endpoint) to assess for change in PTSD symptoms.
Secondary outcome [1] 411637 0
Depression, Anxiety and Stress Scale (DASS-21) will be used to measure depression, anxiety and stress.
Timepoint [1] 411637 0
It will be administered weekly for the duration of treatment and at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion to assess for change in depression, anxiety and stress symptoms.
Secondary outcome [2] 411638 0
Posttraumatic Cognitions Inventory (PTCI) will measure negative cognitions about the self, negative cognitions about the world and self-blame.
Timepoint [2] 411638 0
It will be administered at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [3] 411639 0
Difficulties in Emotion Regulation Scale (DERS-18) will assess emotional awareness and clarity, goals, nonacceptance, impulse control, and emotion regulation strategies
Timepoint [3] 411639 0
It will be administered at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [4] 411640 0
Assessment of Quality of Life (AQoL-8D) measures the quality of life across physical and psychosocial domains
Timepoint [4] 411640 0
It will be administered at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [5] 411641 0
The University of Rhode Island Change Assessment- Trauma (URICA-T) evaluates participants’ readiness to change symptoms related to PTSD
Timepoint [5] 411641 0
It will be administered at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [6] 411642 0
Alcohol Use Disorders Identification Test (AUDIT) asses the alcohol consumption through the amount and frequency of drinking, alcohol dependence and problems caused by the alcohol use
Timepoint [6] 411642 0
It will be administered at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [7] 411643 0
Cannabis Use Disorders Identification Test (CUDIT) captures cannabis abuse and dependence
Timepoint [7] 411643 0
It will be administered at baseline,post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [8] 411644 0
Insomnia Severity Index measures the severity, nature and impact of sleep problems
Timepoint [8] 411644 0
It will be administered at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [9] 411645 0
Dimensions of Anger Reactions (DAR-5) measures characteristic of anger
Timepoint [9] 411645 0
It will be administered at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [10] 411646 0
Daily Inventory of Stressful Events (DISE) assess whether any stressful events had occurred within the past 24 hrs in participant’s life
Timepoint [10] 411646 0
It will be administered weekly for the duration of treatment and at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [11] 411647 0
Session Rating Scale (SRS) reflects the therapist -client relationship, agreement on treatment goals and tasks, overall session ratings
Timepoint [11] 411647 0
It will be administered weekly for the duration of treatment and at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [12] 411648 0
Outcome Rating Scale (ORS) is a measure to assess client’s functioning related to individual, interpersonal, social and overall
Timepoint [12] 411648 0
It will be administered weekly for the duration of treatment and at baseline, post-treatment (two weeks after the completion of the study), and 3-month post-intervention completion.
Secondary outcome [13] 411789 0
Brief revised Working Alliance Inventory (BR-WAI) measures bond, task and goals in a therapeutic relationship between patient and therapist in both standard CPT and CPT-GSH groups.
Timepoint [13] 411789 0
It will be administered upon completion of every 4th therapy session or module and at post-treatment (two weeks after the completion of the study).
Secondary outcome [14] 411790 0
Credibility/Expectancy Questionnaire (CEQ) evaluates the client’s credibility and expectancy in both standard CPT and CPT-GSH groups.
Timepoint [14] 411790 0
It will be administered upon completion of 1st therapy session or module and in the post-treatment (two weeks after the completion of the study).
Secondary outcome [15] 411791 0
Telehealth Satisfaction Scale (TSA) measures participants’ perceptions related to the mode of treatment delivery such as the quality of communication, likelihood of the service and satisfaction with the service.
Timepoint [15] 411791 0
It will be administered at post-treatment (two weeks after the completion of the study)
Secondary outcome [16] 411792 0
Health Service Utilisation assess the use of health, social and other services used by the participants in the past six weeks using a study specific questionnaire. Furthermore, utility score will be generated using AQoL measure for economic evaluation.
Timepoint [16] 411792 0
It will be administered using a study specific questionnaire at post-treatment (two weeks after the completion of the study)
Secondary outcome [17] 412647 0
Feasibility of guided self-help version of cognitive processing therapy will be assessed using a study specific questionnaire for CPT-GSH group
Timepoint [17] 412647 0
Feasibility of CPT-GSH will be assessed at post-treatment (two weeks after the completion of the study)

Eligibility
Key inclusion criteria
Participants should be over 18 years of age, meet diagnostic criteria of full PTSD or subthreshold PTSD specified by the DSM-5. Participants will also need access to a computer or phone with data plan to access the study materials and video call for assessment and therapy sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who do not meet the subthreshold criteria (e.g., PCL score of below 24) are not eligible to participate. Individuals with high risk of harm including significant suicidality or ongoing abuse, substance dependence, unmanaged psychosis or bipolar disorder, and significant cognitive impairment will be excluded from the study on the basis that they should have sufficient level of functioning to participate in the study. Those engaged in concurrent and regular therapy for anxiety/trauma will also be ineligible. Those undertaking medication changes will need to undergo a one-month stabilisation period before pretreatment assessment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is made by an individual independent of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will use covariate-adaptive randomisation using computerised sequence generation that ensures comparable baseline characteristics for PTSD severity, gender, number of comorbid diagnoses and trauma type. Participants will be randomly assigned to either CPT or CPT-GSH in a 1:2 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
IBM Statistical Package for the Social Sciences (SPSS) will be used for data analysis. Linear mixed modelling (LMM) will be used to evaluate treatment effects between pre, post and 3-month follow ups. Chi-square will be used to analyse dichotomous outcomes and independent sample t-tests will be used to measure cost-effectiveness, treatment credibility and other outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2022
Actual
4/10/2022
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
69
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311789 0
University
Name [1] 311789 0
Flinders University
Country [1] 311789 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country
Australia
Secondary sponsor category [1] 313291 0
None
Name [1] 313291 0
Address [1] 313291 0
Country [1] 313291 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311232 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 311232 0
Ethics committee country [1] 311232 0
Australia
Date submitted for ethics approval [1] 311232 0
26/06/2022
Approval date [1] 311232 0
29/07/2022
Ethics approval number [1] 311232 0
2022/HRE00159

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

Contacts
Principal investigator
Name 120406 0
Prof Reg Nixon
Address 120406 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 120406 0
Australia
Phone 120406 0
+61 8 8201 2748
Fax 120406 0
+61 8 8201 3877
Email 120406 0
reg.nixon@flinders.edu.au
Contact person for public queries
Name 120407 0
Priyadharshany Sandanapitchai
Address 120407 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 120407 0
Australia
Phone 120407 0
+61 8 8201 5995
Fax 120407 0
Email 120407 0
traumaunit@flinders.edu.au
Contact person for scientific queries
Name 120408 0
Reg Nixon
Address 120408 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide 5001
South Australia
Country 120408 0
Australia
Phone 120408 0
+61 8 8201 2748
Fax 120408 0
+61 8 8201 3877
Email 120408 0
reg.nixon@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.