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      Evaluation of a Web-Based Self-Help Intervention for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial

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          Abstract

          Background

          Generalized anxiety disorder (GAD) is a highly prevalent and severely distressing condition that can lead to functional impairments and is considered one of the most difficult anxiety disorders to treat. Following new technological developments, a highly structured cognitive behavioral therapy (CBT) approach that has already shown success in face-to-face psychotherapy can be implemented: internet-delivered CBT (iCBT). There is now evidence for the efficacy of both guided and unguided iCBT interventions for GAD regarding symptom reduction.

          Objective

          To establish the usefulness of such interventions, we plan to evaluate the efficacy of a web-based self-help program (Selfapy) for GAD in a relatively large sample. We aim to assess effects beyond symptom reduction, including effects on well-being, functioning, and mental health literacy, as well as the effect on health care burden, while testing the intervention in conditions comparable to routine care.

          Methods

          Patients (n=156) who have been diagnosed with GAD, are aged between 18 and 65 years, have internet access, and have sufficient German language skills will be recruited for this study. The intervention group (n=78) will receive access to the 12-week self-help web-based program Selfapy. The waitlist control group (n=78) will receive no intervention in the context of the study. However, both groups will be allowed to access further health care services (eg, psychotherapy, medication), reflecting current routine care in Germany. Outcome measures will be assessed at baseline (T1) and 6 weeks (T2) and 12 weeks (T3) after the start of the intervention. The primary outcome will be generalized anxiety symptoms and quality of life at T3. Additional outcomes include depression, work capacity, therapy-related expenses and burdens, health literacy, and negative effects.

          Results

          By May 2023, all participants had finished the trial and the report was being prepared for publication.

          Conclusions

          Web-based interventions may be an important addition to the German health care system to reduce barriers to treatment access. Further, they may prove cost-effective for the treatment of GAD.

          Trial Registration

          Deutsches Register Klinischer Studien DRKS00023799; https://tinyurl.com/22bds38x

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/41440

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          Most cited references53

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Robert L Spitzer, Kurt Kroenke, Janet B W Williams … (2006)
          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            The PHQ-9: validity of a brief depression severity measure.

            K Kroenke, R L Spitzer, J B Williams (2001)
            While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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              The WHO-5 Well-Being Index: a systematic review of the literature.

              Christian Topp, Søren Dinesen Østergaard, Susan Søndergaard … (2015)
              The 5-item World Health Organization Well-Being Index (WHO-5) is among the most widely used questionnaires assessing subjective psychological well-being. Since its first publication in 1998, the WHO-5 has been translated into more than 30 languages and has been used in research studies all over the world. We now provide a systematic review of the literature on the WHO-5.
              Article 0 comments Cited 1123 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Christopher Lalk:
                ORCID: https://orcid.org/0000-0002-1793-3507
                Faculty of Psychology and Sport ScienceJustus-Liebig-University GiessenOtto-Behaghel-Straße 10Haus F1Gießen, 35394Germany49 1758438839Christopher.lalk@uni-osnabrueck.de
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: 2023
                Publication date (Electronic): 26 July 2023
                Volume: 12
                Electronic Location Identifier: e41440
                Affiliations
                [1 ] Faculty of Psychology and Sport Science Justus-Liebig-University Giessen Gießen Germany
                [2 ] Faculty of Behavioral and Empirical Cultural Studies Heidelberg University Heidelberg Germany
                [3 ] Clinic and Polyclinic for Psychiatry and Psychotherapy University Hospital Tuebingen Tuebingen Germany
                Author notes
                Corresponding Author: Christopher Lalk Christopher.lalk@ 123456uni-osnabrueck.de
                Author information
                https://orcid.org/0000-0002-9625-6611
                https://orcid.org/0009-0004-7273-7244
                https://orcid.org/0000-0002-4796-9682
                https://orcid.org/0000-0002-3675-6163
                https://orcid.org/0000-0001-7597-027X
                https://orcid.org/0009-0004-5359-9384
                https://orcid.org/0009-0008-5911-4404
                https://orcid.org/0000-0003-1549-0762
                https://orcid.org/0000-0002-1793-3507
                Article
                Publisher ID: v12i1e41440
                DOI: 10.2196/41440
                PMC ID: 10413245
                PubMed ID: 37494105
                SO-VID: 7c946942-5172-4f71-9ecd-4730504ff802
                Copyright © ©Julian Rubel, Jannis Quest, Luise Pruessner, Christina Timm, Steffen Hartmann, Sven Barnow, Lisa Rittmeyer, David Rosenbaum, Christopher Lalk. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.07.2023.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 26 July 2022
                Date revision requested : 15 May 2023
                Date revision received : 1 June 2023
                Date accepted : 19 June 2023
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: generalized anxiety disorder,gad,online self-help,randomized controlled trial,rct,self-help,guided,anxiety,online intervention,mental health,mental illness,mental disorder,psychotherapy,internet-based,internet intervention,web-based
                Data availability:
                Keywords: generalized anxiety disorder, gad, online self-help, randomized controlled trial, rct, self-help, guided, anxiety, online intervention, mental health, mental illness, mental disorder, psychotherapy, internet-based, internet intervention, web-based

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