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). |