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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]

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

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

Symptoms and severity of panic disorder are measured by the Panic Disorder Severity Rating Scale - Self Report (PDSS-SR)

Timepoint [1]

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]

The Agoraphobic Cognitions Questionnaire

Timepoint [2]

At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12

Primary outcome [3]

The Body Sensations Questionnaire

Timepoint [3]

At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12

Secondary outcome [1]

Symptoms and severity of low mood/depression are measured by the Patient Health Questionnaire-9 (PHQ-9)

Timepoint [1]

At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12

Secondary outcome [2]

The Work and Social Adjustment Scale

Timepoint [2]

At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12

Secondary outcome [3]

Working alliance is measured by the Working Alliance Inventory Short Revised (WAI-SR)

Timepoint [3]

Administered at 3 weeks and 6 weeks

Secondary outcome [4]

Psychiatric Diagnostic and Screening Questionnaire (PDSQ)

Timepoint [4]

At pre-treatment, 6 weeks after intervention commencement, post-treatment

Secondary outcome [5]

System Usability Scale

Timepoint [5]

Administered at 3 and 6 weeks

Secondary outcome [6]

Credibility/ Expectancy Questionnaire (CEQ)

Timepoint [6]

Administered at 3 and 6 weeks

Secondary outcome [7]

A modified version of Body vigilance scale

Timepoint [7]

Administered at pre-treatment, 6 weeks after the intervention commencement, and at post-treatment.

Secondary outcome [8]

Panic Attack Cognition Questionnaire (PACQ)

Timepoint [8]

Administered pre-treatment, after 6 weeks, and at post-treatment

Secondary outcome [9]

SS-5; a 5-item shortened version of the Medical Outcomes Study Social Support Scale (MOS-SSS)

Timepoint [9]

at pre-treatment and 6 weeks after intervention commencement

Secondary outcome [10]

Dependent personality disorder traits (Scale from OMNI-IV - Personality Disorder Inventory)

Timepoint [10]

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?

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]

Romania

State/province [1]

Country [2]

Spain

State/province [2]

Country [3]

Italy

State/province [3]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

ACPOR-The Romanian Association for Online Counselling and Psychotherapy

Address [1]

18, Piata 14 Iulie Street, Cluj-Napoca
400325, Cluj

Country [1]

Romania

Funding source category [2]

Government body

Name [2]

Sciex - Scientific Exchange Programme NMS.CH

Address [2]

CRUS
Sciex-MPC
P.O. Box 607
CH-3000 Berne 9

Country [2]

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]

Charities/Societies/Foundations

Name [1]

ACPOR-The Romanian Association for Online Counselling and Psychotherapy

Address [1]

18, Piata 14 Iulie Street, Cluj-Napoca
400325, Cluj

Country [1]

Romania

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical Review Board of The Center for the Management of Scientific Research, Babes-Bolyai University

Ethics committee address [1]

No. 7-9, Universitatii Street, Cluj-Napoca
400091, Cluj

Ethics committee country [1]

Romania

Date submitted for ethics approval [1]

05/05/2014

Approval date [1]

12/05/2014

Ethics approval number [1]

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

Ms Amalia Ciuca

Address

Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology

37, Republicii Street, Cluj-Napoca
400015, Cluj

Country

Romania

Phone

+40 745590576

Fax

amaliaciuca@psychology.ro

Contact person for public queries

Name

Liviu G. Crisan

Address

Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology

37, Republicii Street, Cluj-Napoca
400015, Cluj

Country

Romania

Phone

+40 753 529 753

Fax

liviugcrisan.neuro@gmail.com

Contact person for scientific queries

Name

Amalia Ciuca

Address

Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology

37, Republicii Street, Cluj-Napoca
400015, Cluj

Country

Romania

Phone

+40 745 590 576

Fax

amalia.ciuca@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
386	Study 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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			366360-(Uploaded-14-12-2018-23-24-09)-Basic results summary.docx
Plain language summary	No		A growing body of evidence suggests that Internet-... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Internet-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).	2016	https://dx.doi.org/10.1186/s12888-016-0709-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically