Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial
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...
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| creator | Ebenfeld, Lara Kleine Stegemann, Stefan Lehr, Dirk Ebert, David Daniel Jazaieri, Hooria van Ballegooijen, Wouter Funk, Burkhardt Riper, Heleen Berking, Matthias |
| description | 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.
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.
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.
German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013). |
| doi_str_mv | 10.1186/1745-6215-15-427 |
| format | Article |
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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.
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.
German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/1745-6215-15-427</identifier><identifier>PMID: 25370504</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Agoraphobia ; Agoraphobia - diagnosis ; Agoraphobia - economics ; Agoraphobia - psychology ; Agoraphobia - therapy ; Analysis ; Care and treatment ; Cell Phone ; Clinical Protocols ; Clinical trials ; Cognitive therapy ; Cognitive Therapy - economics ; Cognitive Therapy - instrumentation ; Cognitive Therapy - methods ; Cost benefit analysis ; Health Care Costs ; Humans ; Internet - economics ; Panic Disorder - diagnosis ; Panic Disorder - economics ; Panic Disorder - psychology ; Panic Disorder - therapy ; Psychiatric Status Rating Scales ; Quality of Life ; Research Design ; Severity of Illness Index ; Study Protocol ; Technology application ; Therapy, Computer-Assisted - economics ; Therapy, Computer-Assisted - instrumentation ; Time Factors ; Treatment Outcome</subject><ispartof>Trials, 2014-11, Vol.15 (1), p.427-427, Article 427</ispartof><rights>COPYRIGHT 2014 BioMed Central Ltd.</rights><rights>Ebenfeld et al.; licensee BioMed Central Ltd. 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b523t-f207cdf2a37eda3074ad1ce7d6701efbbc24feebab34dc343f13d6174e0e93103</citedby><cites>FETCH-LOGICAL-b523t-f207cdf2a37eda3074ad1ce7d6701efbbc24feebab34dc343f13d6174e0e93103</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4233107/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4233107/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25370504$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ebenfeld, Lara</creatorcontrib><creatorcontrib>Kleine Stegemann, Stefan</creatorcontrib><creatorcontrib>Lehr, Dirk</creatorcontrib><creatorcontrib>Ebert, David Daniel</creatorcontrib><creatorcontrib>Jazaieri, Hooria</creatorcontrib><creatorcontrib>van Ballegooijen, Wouter</creatorcontrib><creatorcontrib>Funk, Burkhardt</creatorcontrib><creatorcontrib>Riper, Heleen</creatorcontrib><creatorcontrib>Berking, Matthias</creatorcontrib><title>Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial</title><title>Trials</title><addtitle>Trials</addtitle><description>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.
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.
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.
German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).</description><subject>Agoraphobia</subject><subject>Agoraphobia - diagnosis</subject><subject>Agoraphobia - economics</subject><subject>Agoraphobia - psychology</subject><subject>Agoraphobia - therapy</subject><subject>Analysis</subject><subject>Care and treatment</subject><subject>Cell Phone</subject><subject>Clinical Protocols</subject><subject>Clinical trials</subject><subject>Cognitive therapy</subject><subject>Cognitive Therapy - economics</subject><subject>Cognitive Therapy - instrumentation</subject><subject>Cognitive Therapy - methods</subject><subject>Cost benefit analysis</subject><subject>Health Care Costs</subject><subject>Humans</subject><subject>Internet - economics</subject><subject>Panic Disorder - diagnosis</subject><subject>Panic Disorder - economics</subject><subject>Panic Disorder - psychology</subject><subject>Panic Disorder - therapy</subject><subject>Psychiatric Status Rating Scales</subject><subject>Quality of Life</subject><subject>Research Design</subject><subject>Severity of Illness Index</subject><subject>Study Protocol</subject><subject>Technology application</subject><subject>Therapy, Computer-Assisted - economics</subject><subject>Therapy, Computer-Assisted - instrumentation</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1Uk1r3DAQNaWhSdPeeyqCXnpxoi_bmx4KYUk_IJBLehZjfeyqyBpX8gbcX1-5my5ZSNGAhpn3HjNPqqp3jF4wtmovWSebuuWsqUtI3r2ozg6ll0_y0-p1zj8pleJKyFfVKW9ERxsqz6r5xjmvQc8EHQGynfvkDcEYfLRkSuCjjxviMJERotckz8M44ZAJRENggwnGLfYePpE87cxMxoQTagx_KUBSgeHgf1tDNMYpYQglnZKH8KY6cRCyfft4n1c_vtzcr7_Vt3dfv6-vb-u-4WKqHaedNo6D6KwBQTsJhmnbmbajzLq-11w6a3vohTRaSOGYMG3Z3FJ7JRgV59Xnve646wdrtC1jQFBj8gOkWSF4ddyJfqs2-KAkF4XfFYH1XqD3-B-B447GQS3Wq8V6VaK8TFH5-DhGwl87myc1-KxtCBAt7rJiLW9ZKxvOCvTDHrqBYJWPDousXuDqupG0XTXNahG8eAZVjrGDL2Zb50v9iED3BJ0w52TdYQVG1fKdnhv6_VPvDoR__0f8AWY9yFo</recordid><startdate>20141104</startdate><enddate>20141104</enddate><creator>Ebenfeld, Lara</creator><creator>Kleine Stegemann, Stefan</creator><creator>Lehr, Dirk</creator><creator>Ebert, David Daniel</creator><creator>Jazaieri, Hooria</creator><creator>van Ballegooijen, Wouter</creator><creator>Funk, Burkhardt</creator><creator>Riper, Heleen</creator><creator>Berking, Matthias</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20141104</creationdate><title>Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial</title><author>Ebenfeld, Lara ; Kleine Stegemann, Stefan ; Lehr, Dirk ; Ebert, David Daniel ; Jazaieri, Hooria ; van Ballegooijen, Wouter ; Funk, Burkhardt ; Riper, Heleen ; Berking, Matthias</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b523t-f207cdf2a37eda3074ad1ce7d6701efbbc24feebab34dc343f13d6174e0e93103</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Agoraphobia</topic><topic>Agoraphobia - diagnosis</topic><topic>Agoraphobia - economics</topic><topic>Agoraphobia - psychology</topic><topic>Agoraphobia - therapy</topic><topic>Analysis</topic><topic>Care and treatment</topic><topic>Cell Phone</topic><topic>Clinical Protocols</topic><topic>Clinical trials</topic><topic>Cognitive therapy</topic><topic>Cognitive Therapy - economics</topic><topic>Cognitive Therapy - instrumentation</topic><topic>Cognitive Therapy - methods</topic><topic>Cost benefit analysis</topic><topic>Health Care Costs</topic><topic>Humans</topic><topic>Internet - economics</topic><topic>Panic Disorder - diagnosis</topic><topic>Panic Disorder - economics</topic><topic>Panic Disorder - psychology</topic><topic>Panic Disorder - therapy</topic><topic>Psychiatric Status Rating Scales</topic><topic>Quality of Life</topic><topic>Research Design</topic><topic>Severity of Illness Index</topic><topic>Study Protocol</topic><topic>Technology application</topic><topic>Therapy, Computer-Assisted - economics</topic><topic>Therapy, Computer-Assisted - instrumentation</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ebenfeld, Lara</creatorcontrib><creatorcontrib>Kleine Stegemann, Stefan</creatorcontrib><creatorcontrib>Lehr, Dirk</creatorcontrib><creatorcontrib>Ebert, David Daniel</creatorcontrib><creatorcontrib>Jazaieri, Hooria</creatorcontrib><creatorcontrib>van Ballegooijen, Wouter</creatorcontrib><creatorcontrib>Funk, Burkhardt</creatorcontrib><creatorcontrib>Riper, Heleen</creatorcontrib><creatorcontrib>Berking, Matthias</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Trials</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ebenfeld, Lara</au><au>Kleine Stegemann, Stefan</au><au>Lehr, Dirk</au><au>Ebert, David Daniel</au><au>Jazaieri, Hooria</au><au>van Ballegooijen, Wouter</au><au>Funk, Burkhardt</au><au>Riper, Heleen</au><au>Berking, Matthias</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial</atitle><jtitle>Trials</jtitle><addtitle>Trials</addtitle><date>2014-11-04</date><risdate>2014</risdate><volume>15</volume><issue>1</issue><spage>427</spage><epage>427</epage><pages>427-427</pages><artnum>427</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>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.
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.
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.
German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>25370504</pmid><doi>10.1186/1745-6215-15-427</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Agoraphobia Agoraphobia - diagnosis Agoraphobia - economics Agoraphobia - psychology Agoraphobia - therapy Analysis Care and treatment Cell Phone Clinical Protocols Clinical trials Cognitive therapy Cognitive Therapy - economics Cognitive Therapy - instrumentation Cognitive Therapy - methods Cost benefit analysis Health Care Costs Humans Internet - economics Panic Disorder - diagnosis Panic Disorder - economics Panic Disorder - psychology Panic Disorder - therapy Psychiatric Status Rating Scales Quality of Life Research Design Severity of Illness Index Study Protocol Technology application Therapy, Computer-Assisted - economics Therapy, Computer-Assisted - instrumentation Time Factors Treatment Outcome |
| title | Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial |
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