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Trial registered on ANZCTR


Registration number
ACTRN12614000547640
Ethics application status
Approved
Date submitted
17/05/2014
Date registered
22/05/2014
Date last updated
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
PAXonline: A Randomized Controlled Trial Assessing the Efficacy of an Internet-Based Cognitive Behavior Intervention for Panic Disorder
Scientific title
PAXonline: A Randomized Controlled Trial Comparing the Efficacy of an Internet-Based Cognitive Behavior Intervention, delivered with or without assistance from a therapist, to waiting-list in Romanian adults with Panic Disorder
Secondary ID [1] 284620 0
Nil
Universal Trial Number (UTN)
U1111-1156-7294
Trial acronym
PAXPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder 291929 0
Condition category
Condition code
Mental Health 292283 292283 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PAXonline Program for Panic Disorder is an internet-based treatment of twelve weeks, which consists of cognitive-behavioral therapy modules, delivered with or without assistance from a therapist .

The Panic Disorder Program contains 16 modules which address important cognitive behavioral psychotherapy elements such as: psychoeducation on the disorder and means of intervention (Module 1. Understand what’s happening to you and Module 2. Understand what you have to do), techniques for decreasing neurophysiologic hyper-activation (module for breathing regulation, autogenic training relaxation, physical exercise), techniques for cognitive restructuring (attention modification and conscious and unconscious dysfunctional beliefs modification), exposure techniques (interoceptive and exteroceptive), skills training (problem solving) and positive emotions training (positive psychology), behavioral activation and cognitive restructuring of possible comorbid depression symptoms and relapse prevention.

Each module can be completed in 30-40 minutes and the participants are provided with a recommended timetable (one or two modules per week, depending on the complexity of the content and the homework assignments).

In this trial Romanian adults with Panic disorder will be randomly allocated to one of three groups:
Group 1: Guided panic disorder program. Participants in this group will complete the panic disorder treatment program with support from a therapist (weekly emails and regular 15 minutes Skype sessions; in total, there will be 9 Skype sessions).
Group 2: Self-guided panic disorder program. Participants in this group will complete the treatment program in a self-guided format, that is, without support from a therapist.
Group 3: Wait-list control group.


The modules and the entire therapeutic environment is carefully designed in order to catalyze the psychotherapeutic process in the mind of the patients.

The program contains also certain techniques to improve adherence and compliance with the treatment e.g. rewards after module completion (short movies that induce positive emotions), The daily thought, which is sent through e-mail every other 5 days etc.

The participants adherence is carefully monitored through several applications that register: overall usage time, the modules completed and the time spent on each module and each module component. There is also an application, the participants use to report the completion of homework assignments for each module.
Intervention code [1] 289401 0
Treatment: Other
Intervention code [2] 289402 0
Behaviour
Comparator / control treatment
The comparator is a waiting list group.
This group receive their choice of the two treatment options once the other groups have completed the program (after 12 weeks).
Control group
Active

Outcomes
Primary outcome [1] 292148 0
Symptoms and severity of panic disorder are measured by the Panic Disorder Severity Rating Scale - Self Report (PDSS-SR)
Timepoint [1] 292148 0
Administered at pre-treatment, every two weeks after intervention commencement, at post-treatment, and at follow-up: months 1, 3, 6, 12
Primary outcome [2] 292149 0
The Agoraphobic Cognitions Questionnaire
Timepoint [2] 292149 0
At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12
Primary outcome [3] 292150 0
The Body Sensations Questionnaire
Timepoint [3] 292150 0
At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12
Secondary outcome [1] 308297 0
Symptoms and severity of low mood/depression are measured by the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 308297 0
At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12
Secondary outcome [2] 308298 0
The Work and Social Adjustment Scale
Timepoint [2] 308298 0
At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12
Secondary outcome [3] 308299 0
Working alliance is measured by the Working Alliance Inventory Short Revised (WAI-SR)
Timepoint [3] 308299 0
Administered at 3 weeks and 6 weeks
Secondary outcome [4] 308302 0
Psychiatric Diagnostic and Screening Questionnaire (PDSQ)
Timepoint [4] 308302 0
At pre-treatment, 6 weeks after intervention commencement, post-treatment
Secondary outcome [5] 308303 0
System Usability Scale
Timepoint [5] 308303 0
Administered at 3 and 6 weeks
Secondary outcome [6] 308304 0
Credibility/ Expectancy Questionnaire (CEQ)
Timepoint [6] 308304 0
Administered at 3 and 6 weeks
Secondary outcome [7] 308305 0
A modified version of Body vigilance scale
Timepoint [7] 308305 0
Administered at pre-treatment, 6 weeks after the intervention commencement, and at post-treatment.
Secondary outcome [8] 308306 0
Panic Attack Cognition Questionnaire (PACQ)
Timepoint [8] 308306 0
Administered pre-treatment, after 6 weeks, and at post-treatment
Secondary outcome [9] 308307 0
SS-5; a 5-item shortened version of the Medical Outcomes Study Social Support Scale (MOS-SSS)
Timepoint [9] 308307 0
at pre-treatment and 6 weeks after intervention commencement
Secondary outcome [10] 315929 0
Dependent personality disorder traits (Scale from OMNI-IV - Personality Disorder Inventory)
Timepoint [10] 315929 0
administered at pre-treatment

Eligibility
Key inclusion criteria
- primary diagnostic of Panic Disorder (confirmed by an experienced clinician through semi-structured clinical interview)
- computer with internet access
- native Romanian speakers, not necessarily from Romania
- no participation in psychological treatment for panic
disorder in the last 3 months.
- no change in medications in the period 3 month prior to this study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of:
- severe depression
- substance abuse,
- suicidal ideation or behaviors,
- personality disorders,
- psychotic disorders,
- mental retardation,
- benzodiazepines treatment

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)
The first step consists in completing 3 online questionnaires. The first addresses the exclusion criteria, the second identify the panic disorder diagnostic and severity, and the third evaluates other possible comorbidities.

The second step consists in a semi-structured clinical interview conducted through Skype or telephone by a specialist.

If the subject meets all the eligibility criteria, he signs the informed consent document and he is randomly allocated to one of the three groups.

The allocation concealment is performed through the central randomization by a computer. The person in charge with the allocation of subjects to treatment groups is unaware to which group a new subject will be allocated. This person has access only to the data needed to fill out in the computer program the stratification factors used in the process of randomization. The program then automatically allocates the subject to a treatment group by use of an adaptive randomization algorithm. The result or the algorithm can not be influenced by this person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation to intervention is randomized control trial. The method employed is minimization, based on the dynamic algorithm put forward by Pocock & Simon (1975), using two stratification factors: SEVERITY (3 levels) and CHRONICITY (2 levels) of Panic disorder. The severity factor is based on the score obtained at the pre-treatment PDSS-SR measurement. The chronicity factor is measured in the pre-treatment structured clinical interview as the number of months passed since the Panic Disorder has started.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size needed to achieve study objectives has been computed using GPower targeting Manova: Repeated measures, within-between interactions and t-tests for independent and dependent means, expecting a large effect size, a power size of .90 and setting alpha at .05. The recommended sample size has been increased to accommodate an attrition rate of 20%. Thus, the study aims to achieve a sample of 120 participants.

We will measure and test if symptoms significantly improve, both statistically and clinically.

The primary analyses to be made will be intention to treat, but there will be also additional analysis just for the treatment completers.

Missing data for ITT approaches can be managed in a number of ways, but we intend to use the more advanced methods which include the use of multiple imputation and maximum-likelihood based methods.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/05/2014
Actual
28/05/2014
Date of last participant enrolment
Anticipated
22/01/2016
Actual
24/03/2016
Date of last data collection
Anticipated
23/06/2017
Actual
Sample size
Target
120
Accrual to date
Final
111
Recruitment outside Australia
Country [1] 6056 0
Romania
State/province [1] 6056 0
Country [2] 6057 0
Spain
State/province [2] 6057 0
Country [3] 6058 0
Italy
State/province [3] 6058 0

Funding & Sponsors
Funding source category [1] 289247 0
Charities/Societies/Foundations
Name [1] 289247 0
ACPOR-The Romanian Association for Online Counselling and Psychotherapy
Country [1] 289247 0
Romania
Funding source category [2] 291667 0
Government body
Name [2] 291667 0
Sciex - Scientific Exchange Programme NMS.CH
Country [2] 291667 0
Switzerland
Primary sponsor type
University
Name
Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology
Address
37, Republicii Street, Cluj-Napoca
400015, Cluj
Country
Romania
Secondary sponsor category [1] 287921 0
Charities/Societies/Foundations
Name [1] 287921 0
ACPOR-The Romanian Association for Online Counselling and Psychotherapy
Address [1] 287921 0
18, Piata 14 Iulie Street, Cluj-Napoca
400325, Cluj
Country [1] 287921 0
Romania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291016 0
Ethical Review Board of The Center for the Management of Scientific Research, Babes-Bolyai University
Ethics committee address [1] 291016 0
No. 7-9, Universitatii Street, Cluj-Napoca
400091, Cluj
Ethics committee country [1] 291016 0
Romania
Date submitted for ethics approval [1] 291016 0
05/05/2014
Approval date [1] 291016 0
12/05/2014
Ethics approval number [1] 291016 0
31697

Summary
Brief summary
The main objective of this study is to test the efficacy of PAXonline, an internet based cognitive-behavioral therapy program, in the treatment of Panic Disorder. Other important aims are identifying the mechanisms of change and patient characteristics for whom this type of therapy is most suited and has the best results.

Two treatment groups will be used, one with therapist guidance and one without, as well as a wait-list control group.

We expect that the guided intervention program will result in superior outcomes to the unguided intervention program. Both treatment groups are presumed to be superior to the wait-list control.
Trial website
http://studiu.paxonline.ro
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48498 0
Ms Amalia Ciuca
Address 48498 0
Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology

37, Republicii Street, Cluj-Napoca
400015, Cluj
Country 48498 0
Romania
Phone 48498 0
+40 745590576
Fax 48498 0
Email 48498 0
[email protected]
Contact person for public queries
Name 48499 0
Liviu G. Crisan
Address 48499 0
Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology

37, Republicii Street, Cluj-Napoca
400015, Cluj
Country 48499 0
Romania
Phone 48499 0
+40 753 529 753
Fax 48499 0
Email 48499 0
[email protected]
Contact person for scientific queries
Name 48500 0
Amalia Ciuca
Address 48500 0
Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology

37, Republicii Street, Cluj-Napoca
400015, Cluj
Country 48500 0
Romania
Phone 48500 0
+40 745 590 576
Fax 48500 0
Email 48500 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
386Study protocol    https://www.ncbi.nlm.nih.gov/pubmed/26769021 366360-(Uploaded-21-11-2018-21-15-11)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3807Basic resultsNo 366360-(Uploaded-14-12-2018-23-24-09)-Basic results summary.docx
3970Plain language summaryNo A growing body of evidence suggests that Internet-... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInternet-based treatment for Romanian adults with panic disorder: Protocol of a randomized controlled trial comparing a Skype-guided with an unguided self-help intervention (the PAXPD study).2016https://dx.doi.org/10.1186/s12888-016-0709-9
N.B. These documents automatically identified may not have been verified by the study sponsor.