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Table 1 Trial registration data set as recommend by World Health Organization (WHO)

From: 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)

Data category Information
Primary registry and trial identifying number Australian New Zealand Clinical Trial Registry (ANZCTR), ACTRN12614000547640
Date of registration in primary registry 22.05.2014
Secondary identifying numbers Nil, U1111-1156-7294, 366360, 31697
Source(s) of monetary or material support Babes-Bolyai University, Faculty of Psychology; Sciex - Scientific Exchange Programme NMS.CH; The Romanian Association for Online Counselling and Psychotherapy (ACPOR)
Primary sponsor Babes-Bolyai University, Faculty of Psychology; 37, Republicii Street, Cluj-Napoca, 400015, Cluj
Secondary sponsor(s) Sciex - Scientific Exchange Programme NMS.CH; CRUS Sciex-MPC, P.O. Box 607, CH-3000 Berne 9
ACPOR- Cluj-Napoca, Romania
Contact for public queries Babes-Bolyai University, School of Psychology and Educational Sciences, Department of Psychology
Mr Mircea Miclea, Mr Liviu G. Crisan (mirceamiclea@gmail.com; liviugcrisan.neuro@gmail.com)
Contact for scientific queries Ms Amalia Ciuca (amalia.ciuca@psy.unibe.ch; amaliaciuca@psychology.ro) Babes-Bolyai University, School of Psychology and Educational Sciences;
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
Countries of recruitment Romania, Spain, Italy
Health condition(s) or problem(s) studied Mental health, anxiety disorders
Intervention(s) Active comparators: Internet cognitive-behavioral treatment for panic disorder offered with or without assistance from a psychotherapist
Placebo comparator: waiting list group.
Key inclusion and exclusion criteria Inclusion criteria: diagnostic of Panic Disorder (confirmed by an experienced clinician through semi-structured clinical interview); age within the range of 18–65 years; access to a computer with internet connection; written informed consent provided; no participation in psychological treatment for panic disorder in the last 3 months.
Exclusion criteria: severe comorbidities (e.g. bipolar disorders, psychotic disorders, substance abuse); mental retardation; suicidal ideation or behaviors; benzodiazepines treatment
Study type Interventional
Allocation: randomized; Intervention model: parallel assignment Masking: blind outcomes assessment
Primary purpose: treatment
Date of first enrolment 28 May 2014
Target sample size 120 (the target sample size was changed to 192, but an official change was not made in the registry)
Recruitment status Recruiting
Primary outcome(s) Symptoms and severity of panic disorder (PDSS-SR); The Agoraphobic Cognitions Questionnaire; The Body Sensations Questionnaire
Key secondary outcomes Symptoms and severity of depression - Patient Health Questionnaire-9 (PHQ-9); The Work and Social Adjustment Scale; the Working Alliance Inventory Short Revised (WAI-SR); Psychiatric Diagnostic and Screening Questionnaire (PDSQ); Panic Attack Cognition Questionnaire (PACQ); SS-5 - a 5-item shortened version of the Medical Outcomes Study Social Support Scale (MOS-SSS); Credibility/ Expectancy Questionnaire (CEQ); Body vigilance scale (BVS); Dependent personality disorder traits (Scale from OMNI-IV - Personality Disorder Inventory); System Usability Scale (SUS).
  1. Issue date: 17.11.2015
  2. Protocol amendment number: 02
  3. Revision chronology
  4. UM 00, 22.05.2014 Original
  5. UM 01, 17.07.2015 Amendment 01: Changes were registered in Section 4 regarding secondary outcomes (OMNI-IV Dependent Personality Subscale was added) and in Section 8 regarding funding and sponsors (Sciex - Scientific Exchange Programme NMS.CH was added)
  6. UM 02, 17.11.2015 Amendment 02: The time period for recruiting was extended