PAXonline: A Randomized Controlled Trial Assessing the Efficacy of an Internet-Based Cognitive Behavior Intervention for Panic Disorder

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000547640
• Date of registration: 22/05/2014
• Prospective Registration: Yes
• Primary sponsor: Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology
• 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
• Date of first enrolment: 28/05/2014
• Target sample size: 120
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12614000547640.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Italy, Romania, Spain

Contacts

• Name: Ms Amalia Ciuca

• Name: Mr Liviu G. Crisan

Key inclusion & exclusion criteria

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
Exclusion criteria: presence of:
- severe depression
- substance abuse,
- suicidal ideation or behaviors,
- personality disorders,
- psychotic disorders,
- mental retardation,
- benzodiazepines treatment

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Panic Disorder;
Panic Disorder

Mental Health - Anxiety

Intervention(s)

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

Primary Outcome(s)

The Agoraphobic Cognitions Questionnaire [At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12]

Symptoms and severity of panic disorder are measured by the Panic Disorder Severity Rating Scale - Self Report (PDSS-SR)[Administered at pre-treatment, every two weeks after intervention commencement, at post-treatment, and at follow-up: months 1, 3, 6, 12]

The Body Sensations Questionnaire[At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12]

Secondary Outcome(s)

A modified version of Body vigilance scale[Administered at pre-treatment, 6 weeks after the intervention commencement, and at post-treatment.]

The Work and Social Adjustment Scale[At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12]

Dependent personality disorder traits (Scale from OMNI-IV - Personality Disorder Inventory)[administered at pre-treatment]

System Usability Scale[Administered at 3 and 6 weeks]

Psychiatric Diagnostic and Screening Questionnaire (PDSQ)[At pre-treatment, 6 weeks after intervention commencement, post-treatment]

Symptoms and severity of low mood/depression are measured by the Patient Health Questionnaire-9 (PHQ-9)[At pre-treatment, 6 weeks after intervention commencement, post-treatment, and follow-up: months 1, 3, 6, 12]

Panic Attack Cognition Questionnaire (PACQ)[Administered pre-treatment, after 6 weeks, and at post-treatment]

Credibility/ Expectancy Questionnaire (CEQ)[Administered at 3 and 6 weeks]

SS-5; a 5-item shortened version of the Medical Outcomes Study Social Support Scale (MOS-SSS)[at pre-treatment and 6 weeks after intervention commencement ]

Working alliance is measured by the Working Alliance Inventory Short Revised (WAI-SR)[Administered at 3 weeks and 6 weeks]

Secondary ID(s)

Nil

Source(s) of Monetary Support

ACPOR-The Romanian Association for Online Counselling and Psychotherapy

Sciex - Scientific Exchange Programme NMS.CH

Secondary Sponsor(s)

ACPOR-The Romanian Association for Online Counselling and Psychotherapy

Ethics review

Status: Approved
Approval date:
Contact:

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