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Trial registered on ANZCTR


Registration number
ACTRN12621000705886
Ethics application status
Approved
Date submitted
7/05/2020
Date registered
8/06/2021
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Guided Internet Cognitive Behavior Therapy treatment of Posttraumatic Stress Disorder for Romanian population
A study protocol of a randomized controlled trial
Scientific title
Guided Internet Cognitive Behavior Therapy (ICBT) treatment of Posttraumatic Stress Disorder (PAXPTSD) for Romanian population
A study protocol of a randomized controlled trial
Secondary ID [1] 301213 0
None
Universal Trial Number (UTN)
Trial acronym
PAXPTSD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
posttraumatic stress disorder 317363 0
anxiety 317364 0
depression 317365 0
Condition category
Condition code
Mental Health 315470 315470 0 0
Other mental health disorders
Mental Health 315471 315471 0 0
Anxiety
Mental Health 315472 315472 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a two-armed randomized controlled trial (RCT) with one active treatment condition (TC) and a waiting list control group (WL). The diagnostic interview is conducted before and after the treatment by clinicians blind to the treatment group.
The psychologist will be blind according to the score and the evaluations of the participants.
Participants will complete the PAXPTSD with guidance from a psychologist.
After the evaluation process there is one kickoff meeting discussion of approximately 30 minutes, via Skype, videoconference or telephone to discuss the results of assessments and to discuss the next steps. Participants will receive one module per week. At the end of the program there will be another 30 minutes discussion for debriefing using Skype, videoconference or telephone.
The duration and frequency of the intervention will be as follows: one kickoff meeting discussion of approximately 30 minutes; 15 minutes for Q & A for each module; 30 minutes debriefing discussion; the modules will be completed in a maximum of 40 minutes.
The first module will explain the symptoms and the rationale for treatment. Modules 2 and 3 will cover relaxation techniques (breathing training and autogenic training). Module 4 will cover the progressive desensitization regarding the traumatic experience.
Module 5 will cover the cognitive restructuration techniques. Module 6 will cover the confrontation of traumatic memory using expressive writing. Modules 7 and 8 will target the reduction of avoidance through both interoceptive exposure and exteroceptive exposure respectively. Module 9 will discuss trauma as an opportunity for growth. Module 10 will discuss about the development of positive emotions. Modules 11 will discuss relapse prevention.
All participants will complete the standard program for general symptoms of PTSD and it is composed of 11 modules, but the intervention can be personalized according to the comorbidity of participants. We have 5 faculty modules for the comorbidity symptoms.
Facultative modules are activated for every participant by his psychologist according to his comorbidities. The facultative modules will cover the reductions of depressive symptoms, shame, anger, and guilt associated with trauma through psychoeducation, cognitive restructuration, and behavioral activation.
The total duration of the intervention is 11 weeks.
Clinician interviewing and self-report assessments will take place at screening (T0), pre-treatment assessment (T1), post-assessment 11 weeks after randomization (T3), and 3 months follow-up (T4). There will be also weekly mood assessments. All self-report measures are administered through internet and the diagnostic interviews are conducted face to face or via telephone. In case of noncompliance participants will be contacted after 7 days (14, 21) to remind them of assessment completion. After 28 days a short message will be sent via text message. The entire communication between psychologists and participants will be inside the platform. The psychologists from the study will be either licensed psychologists or master students at clinical psychology and psychotherapy. They will support the participants’ adherence by providing reminders using the messaging application available in the platform or via telephone, offering feedback, and monitoring the progress as well as risk for deterioration. Any crisis or any other adverse events are reported to the research team. In cases when participants forget to complete one session, the psychologists will offer reminders and send messages to participants by using platform messages and telephone messages.
Intervention code [1] 317516 0
Treatment: Devices
Comparator / control treatment
Waiting list control group: participants from this group will not receive any kind of intervention for 12 weeks. At the end of the waiting period the participants will receive the intervention program if they want this (after 3 months of study begins) and we will check if they receive any treatment for PTSD and associated problems in this period. Participants from WL complete the assessment phase similar to those in TC.
Control group
Active

Outcomes
Primary outcome [1] 323715 0
The primary outcome measure is PTSD and we will use multiple measures.
We will use the PTSD Symptom Scale - Interview for DSM-5 (PSS-I-5). Presence on PSS-I-5 of 1 intrusion symptom, 1 avoidance symptom, 2 cognition, and mood symptoms and 2 arousal symptoms for a period of 1 month. Significant distress or interference is also necessary to be present and to diagnose PTSD (operationalized as a score of 2 or higher on either item 21 or 22).
We have multiple timepoint: pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention, and follow up (3 months). The primary endpoint is post-intervention.
Timepoint [1] 323715 0
post-intervention (primary endpoint)
Primary outcome [2] 325816 0
To evaluate de catastrophic cognition associated with PTSD symptom we will use The Posttraumatic Cognitions Inventory (PTCI).
Timepoint [2] 325816 0
It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention (primary endpoint) and follow up (3 months).
Primary outcome [3] 325817 0
To evaluate the severity of PTSD we will use PDS-5 with a cutoff point of 28 as a possible diagnosis of PTSD.
Timepoint [3] 325817 0
It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention (primary endpoint) and follow up (3 months).
Secondary outcome [1] 389230 0
We will use PTSD Checklist for DSM-5 (PCL-5) for screening and monitor the symptoms. Cutoff point of 31 was demonstrated to be optimally efficient to diagnose PTSD and we will use it in the study.
Timepoint [1] 389230 0
It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention and follow up (3 months).
Secondary outcome [2] 389231 0
General Anxiety Disorder GAD-7 Symptoms of general anxiety disorder
Timepoint [2] 389231 0
It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention and follow up (3 months).
Secondary outcome [3] 389232 0
The work and social adjustment scale WSAS Functional impairment
Timepoint [3] 389232 0
It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention and follow up (3 months).
Secondary outcome [4] 396099 0
Symptoms and severity of depression using Patient health questionnaire-9 PHQ-9
Timepoint [4] 396099 0
It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention and follow-up (3 months).

Eligibility
Key inclusion criteria
People with have a diagnostic of PTSD according to DSM-V criteria assessed by diagnostic raters using Posttraumatic Stress Disorder Symptom Scale Interview for DSM-V (PSSI-5), have access to internet connection (via computer, laptop, telephone, tablet), have a valid email address, are native Romanian speakers; and have signed a written informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They are currently enrolled in a different psychotherapeutic program or they received psychotherapy in the previous 3 months; they present severe comorbidities, other than mild depression or other anxiety disorder (e.g. bipolar disorders, psychotic disorders, severe personality disorder, substance abuse); they suffer from mental retardation; they present suicidal ideation or behaviors (assessed by Patient health questionnaire- 9, PHQ-9) (Kronke, Spitzer, Williams, Lowe, 2010); present excessive drinking problems scoring 19 or higher on Alcohol Use Disorders Identifications Test, AUDIT (Saunders et al., 1993).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/06/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment outside Australia
Country [1] 22532 0
Romania
State/province [1] 22532 0
Country [2] 22533 0
Spain
State/province [2] 22533 0
Country [3] 22534 0
Italy
State/province [3] 22534 0
Country [4] 22535 0
France
State/province [4] 22535 0
Country [5] 22536 0
Germany
State/province [5] 22536 0

Funding & Sponsors
Funding source category [1] 305660 0
University
Name [1] 305660 0
Babes-Bolyai University
Country [1] 305660 0
Romania
Primary sponsor type
University
Name
Babes-Bolyai University
Address
Str. Mihail Kogalniceanu, nr. 1
400084, Cluj-Napoca, România
Country
Romania
Secondary sponsor category [1] 306071 0
None
Name [1] 306071 0
Address [1] 306071 0
Country [1] 306071 0
Romania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305945 0
Ethical Review Board of The Center for the Management of Scientific Research Babes-Bolyai University
Ethics committee address [1] 305945 0
Ethics committee country [1] 305945 0
Romania
Date submitted for ethics approval [1] 305945 0
01/06/2020
Approval date [1] 305945 0
17/06/2020
Ethics approval number [1] 305945 0
8.139

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

Contacts
Principal investigator
Name 102158 0
Miss Ioana laura Dumbrava
Address 102158 0
Department of Psychology
Babes-Bolyai University
Republicii 37, 400015
Cluj-Napoca, Romania
Country 102158 0
Romania
Phone 102158 0
+40 0748214983
Fax 102158 0
Email 102158 0
ioanadumbrava@psychology.ro
Contact person for public queries
Name 102159 0
Ioana Laura Dumbrava
Address 102159 0
Department of Psychology
Babes-Bolyai University
Republicii 37, 400015
Cluj-Napoca, Romania
Country 102159 0
Romania
Phone 102159 0
+40 0748214983
Fax 102159 0
Email 102159 0
ioanadumbrava@psychology.ro
Contact person for scientific queries
Name 102160 0
Ioana Laura Dumbrava
Address 102160 0
Department of Psychology
Babes-Bolyai University
Republicii 37, 400015
Cluj-Napoca, Romania
Country 102160 0
Romania
Phone 102160 0
+40 0748214983
Fax 102160 0
Email 102160 0
ioanadumbrava@psychology.ro

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
I will not be sharing the individual data considering the ethical issues involved (the potential implications for GDPR).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7894Study protocol  ioanadumbrava@psychology.ro 379775-(Uploaded-07-05-2020-21-58-02)-Study-related document.pdf



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.