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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
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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
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Secondary ID [1]
301213
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None
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Universal Trial Number (UTN)
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Trial acronym
PAXPTSD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
posttraumatic stress disorder
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anxiety
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depression
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Condition category
Condition code
Mental Health
315470
315470
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0
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Other mental health disorders
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Mental Health
315471
315471
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0
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Anxiety
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Mental Health
315472
315472
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0
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Depression
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
317516
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
323715
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Timepoint [1]
323715
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post-intervention (primary endpoint)
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Primary outcome [2]
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To evaluate de catastrophic cognition associated with PTSD symptom we will use The Posttraumatic Cognitions Inventory (PTCI).
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Assessment method [2]
325816
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Timepoint [2]
325816
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It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention (primary endpoint) and follow up (3 months).
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Primary outcome [3]
325817
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To evaluate the severity of PTSD we will use PDS-5 with a cutoff point of 28 as a possible diagnosis of PTSD.
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Assessment method [3]
325817
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Timepoint [3]
325817
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It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention (primary endpoint) and follow up (3 months).
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Secondary outcome [1]
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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.
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Assessment method [1]
389230
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Timepoint [1]
389230
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It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention and follow up (3 months).
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Secondary outcome [2]
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General Anxiety Disorder GAD-7 Symptoms of general anxiety disorder
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Assessment method [2]
389231
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Timepoint [2]
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It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention and follow up (3 months).
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Secondary outcome [3]
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The work and social adjustment scale WSAS Functional impairment
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Assessment method [3]
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Timepoint [3]
389232
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It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention and follow up (3 months).
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Secondary outcome [4]
396099
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Symptoms and severity of depression using Patient health questionnaire-9 PHQ-9
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Assessment method [4]
396099
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Timepoint [4]
396099
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It will be evaluated pre-treatment, mid interventions (after 6 weeks of study begins), post-intervention and follow-up (3 months).
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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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/06/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
108
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
22532
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Romania
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State/province [1]
22532
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Country [2]
22533
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Spain
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State/province [2]
22533
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Country [3]
22534
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Italy
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State/province [3]
22534
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Country [4]
22535
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France
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State/province [4]
22535
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Country [5]
22536
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Germany
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State/province [5]
22536
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Funding & Sponsors
Funding source category [1]
305660
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University
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Name [1]
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Babes-Bolyai University
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Address [1]
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Str. Mihail Kogalniceanu, nr. 1
400084, Cluj-Napoca, România
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Country [1]
305660
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Romania
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Primary sponsor type
University
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Name
Babes-Bolyai University
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Address
Str. Mihail Kogalniceanu, nr. 1
400084, Cluj-Napoca, România
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Country
Romania
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Secondary sponsor category [1]
306071
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None
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Name [1]
306071
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Address [1]
306071
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Country [1]
306071
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Romania
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305945
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Ethical Review Board of The Center for the Management of Scientific Research Babes-Bolyai University
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Ethics committee address [1]
305945
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Str. Mihail Kogalniceanu, nr. 1
400084, Cluj-Napoca, România
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Ethics committee country [1]
305945
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Romania
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Date submitted for ethics approval [1]
305945
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01/06/2020
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Approval date [1]
305945
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17/06/2020
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Ethics approval number [1]
305945
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8.139
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Summary
Brief summary
The current study focused on individuals with an established diagnosis of PTSD. The aim of the study is to investigate the effects of guided internet cognitive behavioral therapy on measures of posttraumatic stress disorder symptoms, depression, and other anxiety symptoms, as well as quality of life against a control group and the maintenance of the improvments. The study will have an intervention group and a control group. The intervention group will receive access to an online psychotherapeutic intervention for people with PTSD diagnoses. We expect that the effect size for our program to be in accord with other programs delivered to patients with posttruamtic stress disorder.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Ioana laura Dumbrava
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Address
102158
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Department of Psychology
Babes-Bolyai University
Republicii 37, 400015
Cluj-Napoca, Romania
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Country
102158
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Romania
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Phone
102158
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+40 0748214983
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Fax
102158
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Email
102158
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[email protected]
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Contact person for public queries
Name
102159
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Miss Ioana Laura Dumbrava
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Address
102159
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Department of Psychology
Babes-Bolyai University
Republicii 37, 400015
Cluj-Napoca, Romania
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Country
102159
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Romania
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Phone
102159
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+40 0748214983
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Fax
102159
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Email
102159
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[email protected]
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Contact person for scientific queries
Name
102160
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Miss Ioana Laura Dumbrava
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Address
102160
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Department of Psychology
Babes-Bolyai University
Republicii 37, 400015
Cluj-Napoca, Romania
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Country
102160
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Romania
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Phone
102160
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+40 0748214983
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Fax
102160
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Email
102160
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
I will not be sharing the individual data considering the ethical issues involved (the potential implications for GDPR).
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7894
Study protocol
[email protected]
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.
Download to PDF