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Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial.

Ebenfeld L, Kleine Stegemann S, Lehr D, Ebert DD, Jazaieri H, van Ballegooijen W, Funk B, Riper H, Berking M - Trials (2014)

Bottom Line: However, little is known about the clinical effects of integrating mobile technology into these interventions.Moreover, a cost-effectiveness analysis will be performed from a societal perspective.The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults.

View Article: PubMed Central - PubMed

Affiliation: Division of Health Training Online, Leuphana University Lueneburg, Innovation Incubator, Rotenbleicher Weg 67, 21335 Lueneburg, Germany. ebenfeld@inkubator.leuphana.de.

ABSTRACT

Background: Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks.

Methods/design: A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol.

Discussion: To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults.

Trial registration: German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

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Related in: MedlinePlus

Overview of study procedure. BDI-II, Beck Depression Inventory II; PAS, Panic and agoraphobia scale; SCID-I, Structured clinical interview for DSM-IV Axis I Disorders.
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Fig1: Overview of study procedure. BDI-II, Beck Depression Inventory II; PAS, Panic and agoraphobia scale; SCID-I, Structured clinical interview for DSM-IV Axis I Disorders.

Mentions: We will conduct an RCT with two arms: an internet-based self-help intervention supported by a mobile application with minimal guidance from a coach (GET.ON PANIC), and a waitlist control group who will receive the intervention after a six-month follow-up assessment. Assessments will be conducted prior to randomization, at post-treatment (eight weeks), as well as at the three- and six-month follow-up assessments (see Figure 1). The Ethical Committee of Marburg approved this study (number: 2013-23 K), and it was registered with the German Clinical Trial Register (registration number: DRKS00005223).Figure 1


Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial.

Ebenfeld L, Kleine Stegemann S, Lehr D, Ebert DD, Jazaieri H, van Ballegooijen W, Funk B, Riper H, Berking M - Trials (2014)

Overview of study procedure. BDI-II, Beck Depression Inventory II; PAS, Panic and agoraphobia scale; SCID-I, Structured clinical interview for DSM-IV Axis I Disorders.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4233107&req=5

Fig1: Overview of study procedure. BDI-II, Beck Depression Inventory II; PAS, Panic and agoraphobia scale; SCID-I, Structured clinical interview for DSM-IV Axis I Disorders.
Mentions: We will conduct an RCT with two arms: an internet-based self-help intervention supported by a mobile application with minimal guidance from a coach (GET.ON PANIC), and a waitlist control group who will receive the intervention after a six-month follow-up assessment. Assessments will be conducted prior to randomization, at post-treatment (eight weeks), as well as at the three- and six-month follow-up assessments (see Figure 1). The Ethical Committee of Marburg approved this study (number: 2013-23 K), and it was registered with the German Clinical Trial Register (registration number: DRKS00005223).Figure 1

Bottom Line: However, little is known about the clinical effects of integrating mobile technology into these interventions.Moreover, a cost-effectiveness analysis will be performed from a societal perspective.The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults.

View Article: PubMed Central - PubMed

Affiliation: Division of Health Training Online, Leuphana University Lueneburg, Innovation Incubator, Rotenbleicher Weg 67, 21335 Lueneburg, Germany. ebenfeld@inkubator.leuphana.de.

ABSTRACT

Background: Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks.

Methods/design: A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol.

Discussion: To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults.

Trial registration: German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

Show MeSH
Related in: MedlinePlus