Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention
BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to i...
Ausführliche Beschreibung
Autor*in: |
Ai Ito [verfasserIn] Fumikazu Hiyoshi [verfasserIn] Ayako Kanie [verfasserIn] Azumi Maruyama [verfasserIn] Mari S Oba [verfasserIn] Shinsuke Kito [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
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2023 |
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Übergeordnetes Werk: |
In: JMIR Research Protocols - JMIR Publications, 2013, 12, p e49698(2023) |
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Übergeordnetes Werk: |
volume:12, p e49698 ; year:2023 |
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DOI / URN: |
10.2196/49698 |
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Katalog-ID: |
DOAJ09069662X |
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520 | |a BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 | ||
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700 | 0 | |a Shinsuke Kito |e verfasserin |4 aut | |
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10.2196/49698 doi (DE-627)DOAJ09069662X (DE-599)DOAJ3bd8129fe1844e2e9f6aad5613cfdb10 DE-627 ger DE-627 rakwb eng R858-859.7 Ai Ito verfasserin aut Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 Medicine R Computer applications to medicine. Medical informatics Fumikazu Hiyoshi verfasserin aut Ayako Kanie verfasserin aut Azumi Maruyama verfasserin aut Mari S Oba verfasserin aut Shinsuke Kito verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 12, p e49698(2023) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:12, p e49698 year:2023 https://doi.org/10.2196/49698 kostenfrei https://doaj.org/article/3bd8129fe1844e2e9f6aad5613cfdb10 kostenfrei https://www.researchprotocols.org/2023/1/e49698 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12, p e49698 2023 |
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10.2196/49698 doi (DE-627)DOAJ09069662X (DE-599)DOAJ3bd8129fe1844e2e9f6aad5613cfdb10 DE-627 ger DE-627 rakwb eng R858-859.7 Ai Ito verfasserin aut Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 Medicine R Computer applications to medicine. Medical informatics Fumikazu Hiyoshi verfasserin aut Ayako Kanie verfasserin aut Azumi Maruyama verfasserin aut Mari S Oba verfasserin aut Shinsuke Kito verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 12, p e49698(2023) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:12, p e49698 year:2023 https://doi.org/10.2196/49698 kostenfrei https://doaj.org/article/3bd8129fe1844e2e9f6aad5613cfdb10 kostenfrei https://www.researchprotocols.org/2023/1/e49698 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12, p e49698 2023 |
allfields_unstemmed |
10.2196/49698 doi (DE-627)DOAJ09069662X (DE-599)DOAJ3bd8129fe1844e2e9f6aad5613cfdb10 DE-627 ger DE-627 rakwb eng R858-859.7 Ai Ito verfasserin aut Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 Medicine R Computer applications to medicine. Medical informatics Fumikazu Hiyoshi verfasserin aut Ayako Kanie verfasserin aut Azumi Maruyama verfasserin aut Mari S Oba verfasserin aut Shinsuke Kito verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 12, p e49698(2023) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:12, p e49698 year:2023 https://doi.org/10.2196/49698 kostenfrei https://doaj.org/article/3bd8129fe1844e2e9f6aad5613cfdb10 kostenfrei https://www.researchprotocols.org/2023/1/e49698 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12, p e49698 2023 |
allfieldsGer |
10.2196/49698 doi (DE-627)DOAJ09069662X (DE-599)DOAJ3bd8129fe1844e2e9f6aad5613cfdb10 DE-627 ger DE-627 rakwb eng R858-859.7 Ai Ito verfasserin aut Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 Medicine R Computer applications to medicine. Medical informatics Fumikazu Hiyoshi verfasserin aut Ayako Kanie verfasserin aut Azumi Maruyama verfasserin aut Mari S Oba verfasserin aut Shinsuke Kito verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 12, p e49698(2023) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:12, p e49698 year:2023 https://doi.org/10.2196/49698 kostenfrei https://doaj.org/article/3bd8129fe1844e2e9f6aad5613cfdb10 kostenfrei https://www.researchprotocols.org/2023/1/e49698 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12, p e49698 2023 |
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10.2196/49698 doi (DE-627)DOAJ09069662X (DE-599)DOAJ3bd8129fe1844e2e9f6aad5613cfdb10 DE-627 ger DE-627 rakwb eng R858-859.7 Ai Ito verfasserin aut Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 Medicine R Computer applications to medicine. Medical informatics Fumikazu Hiyoshi verfasserin aut Ayako Kanie verfasserin aut Azumi Maruyama verfasserin aut Mari S Oba verfasserin aut Shinsuke Kito verfasserin aut In JMIR Research Protocols JMIR Publications, 2013 12, p e49698(2023) (DE-627)749502304 (DE-600)2719222-2 19290748 nnns volume:12, p e49698 year:2023 https://doi.org/10.2196/49698 kostenfrei https://doaj.org/article/3bd8129fe1844e2e9f6aad5613cfdb10 kostenfrei https://www.researchprotocols.org/2023/1/e49698 kostenfrei https://doaj.org/toc/1929-0748 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12, p e49698 2023 |
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Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention |
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BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 |
abstractGer |
BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 |
abstract_unstemmed |
BackgroundThe clinical usefulness of cognitive behavioral therapy (CBT) for patients with depression who do not remit with pharmacotherapy has been recognized. However, the longer time burden on health care providers associated with conducting CBT and the lack of a system for providing CBT lead to inadequate CBT provision to patients who wish to receive it. ObjectiveWe aim to evaluate the feasibility of introducing virtual reality (VR) into CBT for patients with depression. MethodsThis is a single-center, interventional, exploratory, single-arm, nonrandomized, open, pre-post–comparative feasibility study of an unapproved medical device program to evaluate the acceptability, preliminary efficacy, and safety of the study device. Eligible patients meet the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) for major depressive disorder, have a 17-item Hamilton Depression Rating Scale (HAMD-17) score of ≥12, and are aged 18-65 years. The sample will comprise 12 patients. VR-based CBT (CBT-VR) sessions will be conducted once a week in an outpatient setting. CBT-VR has been developed in accordance with 6 stages and 16 sessions in the current CBT therapist manual. VR contents and other components correspond to the themes of these 16 sessions. The flow of CBT-VR treatment is similar to that of normal CBT; however, this product replaces the in-person portion of CBT. The primary end point will be the change in the HAMD-17 score from baseline up to 16 sessions. Secondary end points will be treatment retention; psychiatrist consultation time; satisfaction with the equipment or program; ease of use; homework compliance; change in the HAMD-17 score from baseline up to 8 sessions; change in Montgomery-Åsberg Depression Rating Scale (MADRS), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), EQ-5D-5L, and Clinical Global Impressions (CGI) scores from baseline up to 8 and 16 sessions; and change in remission and response rates and HAMD-17, MADRS, QIDS-SR, and EQ-5D-5L scores from baseline to 3 and 6 months post intervention (or discontinuation). CBT-VR’s feasibility will be assessed at baseline, after 8 sessions, after 16 sessions, or treatment discontinuation, by measuring the time required for testing and medical care during each session and with a patient questionnaire. After intervention discontinuation, a follow-up evaluation will be conducted unless the patient withdraws consent or otherwise discontinues participation in the study after 3 and 6 months. ResultsParticipant recruitment started on November 30, 2022, and data collection is ongoing as of September 2023. ConclusionsThis study is the first step in testing the acceptability, feasibility, and preliminary efficacy and safety of CBT-VR for patients with depression without controls in an open-label trial. If its feasibility for depression treatment is confirmed, we intend to proceed to a large-scale validation study. Trial RegistrationJapan Registry of Clinical Trials jRCTs032220481; https://jrct.niph.go.jp/en-latest-detail/jRCTs032220481 International Registered Report Identifier (IRRID)DERR1-10.2196/49698 |
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title_short |
Feasibility Study of Virtual Reality–Based Cognitive Behavioral Therapy for Patients With Depression: Protocol for an Open Trial and Therapeutic Intervention |
url |
https://doi.org/10.2196/49698 https://doaj.org/article/3bd8129fe1844e2e9f6aad5613cfdb10 https://www.researchprotocols.org/2023/1/e49698 https://doaj.org/toc/1929-0748 |
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Fumikazu Hiyoshi Ayako Kanie Azumi Maruyama Mari S Oba Shinsuke Kito |
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up_date |
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