Trial document




drksid header

  DRKS00005223

Trial Description

start of 1:1-Block title

Title

smartphone-based online-training for panicattacks and agoraphobia

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.geton-training.de/Panik.php

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The online panic training GET.ON Panik is for persons suffering from panic attacks and agoraphobia and who want to learn to deal with it more constructively.
The main focus is on practical exercises to confront with anxiety. The purpose of these exercises is to expose oneself consciously to individual fear-evoking situations or to provoke physical symptoms similar to panic. In this way it is possible to gain new and helpful experiences with anxiety – namely that anxiety is extremely unpleasant but possible to endure or that fear is a temporary feeling that becomes more bearable with increasing practice and that feared consequences are often less severe than expected. As support for these exercises a mobile application (app) for the smartphone will be used which allows an everyday training. This app contains a diary in which single panic attacks are documented and the development of anxiety symptoms during the training is recorded.
The aim of the study is the evaluation of the efficicy of the online-training GET.ON Panik. In a randomised controlled trial the intervention group will be compared with a waitlist-control-group. GET.ON Panik should help affected people to reduce panic attacks and their fear of panic attacks in the long term and to increase the quality of life.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Panic disorder with and without agoraphobia is one of the most prevalent anxiety disorders worldwide (Jacobi et al., 2004). Current meta-analyses prove a good efficacy of internet-based interventions for panic disorders on average (Andrews et al., 2010; Cuijpers et al., 2009; Haug, Nordgreen, Öst, & Havik, 2012). In cognitive oriented trainings clients typically complete exercises at their computers at home. However, in trainings that aim more at the behavior and the experience during the exposure with fear, it is necessary to integrate exercises in everyday situations. In most cases this does not happen in front of the computer. Smartphones, as a time- and location-independent technology, represent a promising support during exposition exercises (Heron & Smyth, 2010).
The main objective of this randomised controlled trial is to evaluate the efficacy of the smartphone-based online-training GET.ON Panik. In the randomised controlled trial 90 participants will be recruited from the general population. For a better description of the sample a SKID interview will be done. The reduction of the panic and agoraphobia symptoms will be determined through the Panic and Agoraphobia Scale (PAS), the Body Sensations Questionnaires, Agoraphobic Cognitions Questionnaires and Mobility Inventory (AKV) and the Hamilton Anxiety Rating Scale (HAMA).
Inclusion criteria for the participation is a minimum age of 18 years, mild to moderate panic symptoms with and without agoraphobia (PAS 9-28), internet access, availability of a smartphone (iPhone or Android-based device) and a signed informed consent via mail or email. Persons with an increased suicide risk (Beck Depression Inventory item 9 suicidality > 1, SCID section A: affective disorder, question A9), a severe physical or mental disorder and who are currently undertaking psychotherapy or are on a waiting list for it will be excluded.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005223
  •   2013/08/15
  •   [---]*
  •   yes
  •   Approved
  •   2013-23k, Marburg - Ethikkommission des Fachbereichs Psychologie der Philipps-Universität Marburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F40.01 -  [generalization F40.0: Agoraphobia]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   six-week online training with supporting emails (guided self-help). Half of the total sample (N = 90, n = 45) gets access to “GET.ON Panik” and the smartphone app “GET.ON PAPP”. Both are components of an online training to manage panic attacks and agoraphobia based on cognitive behavioral therapy. The training aims at reducing the severity of panic symptoms which are measured by the Panic and Agoraphobia Scale (PAS). The training consists of 6 lessons that are processed weekly. A lesson consists of information, exercises and homework. The smartphone supports during homework regarding the diary and exposures tasks. The expected average processing time of a lesson is approximately 60 minutes.
  •   waitlist-control-group (receives online-training without supporting e-mails following the 6-months follow-up). Before Arm 1 gets access to the online-training (GET.ON Panik), both groups, Arm 1 and Arm 2, fill in the Baseline questionnaires (online). After Arm 1 worked through the online-training (8 weeks), Arm 1 and Arm 2 fill in the post-questionnaires (online). At 3- and 6-months follow-up, again online questionnaires are to be filled in. The questionnaires assess panic severity, agoraphobia, depressive symptoms, etc. After the last assessment, 6 months after randomization, Arm 2 receives access to GET.ON Panik. During the training, Arm 2 does not receive regular e-mail support, but an online-coach is available when a participant has a question.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Severity of panic and agoraphobia symptoms, measured with Panic and Agoraphobia Scale (PAS; Bandelow, 1997) before the training (baseline), after the training (8 weeks), at 3-months follow-up and at 6-months follow-up

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Panic and agoraphobia symptoms:
- measures with Questionnaire on Body-related Anxiety, Cognitions and Avoidance (AKV), pre, post (8 weeks), 3- and 6-months follow-up,
- measures with Hamilton Anxiety Scale (HAMA), pre, post (8 weeks), 3- and 6-months follow-up;

Depressive symptoms: measures with Center for Epidemilogic Studies Depression Scale (CES-D), pre, post (8 weeks), 3- and 6-months follow-up;

Quality of life:
- measures with Short version of Health Survey (SF-12), pre, post (8 weeks), 3- and 6-months follow-up,
- measures with EuroQuol (EQ-5D), pre, post (8 weeks), 3- and 6-months follow-up;

Acceptance of the Smartphone app: measured with questionnaire based technology acceptance model (TAM), 1., 2. and 5. week during training;

Usability: measured with System Usability Scale (SUS), post (8 weeks);

Costs associated with psychiatric Illness: measured with German adaptation of the Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TiC-P), pre, 6-months follow-up;

Side effects of the online training: measured with adaptation of the German Inventary for the Assessment of negative side effects of psychotherapy (INEP), post (8 weeks);

Satisfaction with the online training: measured with German adaptation of the ZUF 8, which is the German version of the Client Satisfaction Questionnaire (CSQ), post (8 weeks)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2013/08/19
  •   90
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

clinical relevant complaints about panic attacks and agoraphobia (Panic and Agoraphobia Scale 9-28), internet access, availability of a smartphone, valid email address

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- suicidality at baseline, measured with item 9 of the BDI II (value > 1) and question A9 of the SCID, section A: affective disorder
- psychotic and dissociative disorders
- current psychotherapeutic treatment or on the waiting list for such a treatment
- not willing to sign the consent form

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Leuphana Universität Lüneburg GET.ON Gesundheitstraining.Online / Innovations-Inkubator
    • Mr.  Dr.  Dirk  Lehr 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Leuphana Universität LüneburgGET.ON GesundheitsTraining.Online / Innovations-Inkubator
    • Ms.  M.Sc.  Lara  Ebenfeld 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Leuphana Universität LüneburgGET.ON GesundheitsTraining.Online / Innovations-Inkubator
    • Ms.  M.Sc.  Lara  Ebenfeld 
    • Rotenbleicher Weg 67
    • 21335  Lüneburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • European Union (finanzielle Förderung organisiert über NBank bzw. Niedersächsisches Ministerium für Wirtschaft, Arbeit und Verkehr
    • Friedrichwall 1
    • 30159  Hannover
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.