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Appropriate controls for digital therapeutic clinical trials: A narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content
16 references·16 citing·54 second hopsampled
Appropriate controls for digital therapeutic clinical trials: A narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content (2022)Appropriate controls for digital therapeu…Banbury Forum Consensus Statement on the Path Forward for Digital Mental Health Treatment (2021)Banbury Forum Consensus State…Digital mental health apps and the therapeutic alliance: initial review (2019)Digital mental health apps an…Clinically Meaningful Use of Mental Health Apps and its Effects on Depression: Mixed Methods Study (2019)Clinically Meaningful Use of …Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms (2017)Efficacy of Self-guided Inter…The digital placebo effect: mobile mental health meets clinical psychiatry (2016)The digital placebo effect: m…Form of delivery as a key ‘active ingredient’ in behaviour change interventions (2016)Form of delivery as a key ‘ac…How important are the common factors in psychotherapy? An update (2015)How important are the common …Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014)Better reporting of intervent…A Randomized, Placebo-Controlled Trial of Online Cognitive Behavioral Therapy for Chronic Insomnia Disorder Delivered via an Automated Media-Rich Web Application (2012)A Randomized, Placebo-Control…Mediators and Mechanisms of Change in Psychotherapy Research (2007)Mediators and Mechanisms of C…Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials (2004)Blinding was judged more diff…The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration (2001)The Revised CONSORT Statement…Behavioral Activation Treatment for Depression: Returning to Contextual Roots (2001)Behavioral Activation Treatme…The heart and soul of change: What works in therapy. (1999)The heart and soul of change:…The empirical case for the common factors in therapy: Quantitative findings. (1999)The empirical case for the co…Pleasant activities and depression. (1973)Pleasant activities and depre…From awareness to integration: a qualitative interview study on the impact of digital therapeutics on physicians’ practices in Germany (2025)From awareness to integration…Feasibility of a digital therapeutic for experiential negative symptoms of schizophrenia: results from an exploratory study (2025)Feasibility of a digital ther…Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies (2025)Digital therapeutics as a new…Analyzing metaverse-based digital therapies, their effectiveness, and potential risks in mental healthcare (2025)Analyzing metaverse-based dig…A digital therapeutic (CT-152) as adjunct to antidepressant medication: A phase 3 randomized controlled trial (the Mirai study) (2025)A digital therapeutic (CT-152…Self-help digital mental health intervention in improving burnout and mental health outcomes among healthcare workers: A narrative review (2024)Self-help digital mental heal…Exploring the potential of digital therapeutics: An assessment of progress and promise (2024)Exploring the potential of di…Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study (2024)Evaluating the Efficacy of a …Elderly patients' reactions to gamification-based digital therapeutics (DTx): The relevance of socialization tendency seeking (2024)Elderly patients' reactions t…Use and Engagement With Low-Intensity Cognitive Behavioral Therapy Techniques Used Within an App to Support Worry Management: Content Analysis of Log Data (2023)Use and Engagement With Low-I…Systematic Review of Extended Reality Digital Therapy for Enhancing Mental Health Among South Korean Adolescents and Young Adults (2023)Systematic Review of Extended…Economic Evaluation Associated With Clinical-Grade Mobile App–Based Digital Therapeutic Interventions: Systematic Review (2023)Economic Evaluation Associate…Digital therapeutics in the clinic (2023)Digital therapeutics in the c…Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology (2023)Digital Therapeutics as a New…Development and Evaluation of a Smartphone-Based Chatbot Coach to Facilitate a Balanced Lifestyle in Individuals With Headaches (BalanceUP App): Randomized Controlled Trial (2023)Development and Evaluation of…Challenges With the Use of Digital Sham: Systematic Review and Recommendations (2023)Challenges With the Use of Di…Attachment and Loss (1969)The generalizability of the psychoanalytic concept of the working alliance. 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References

  • 2014Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide10,521 cited
  • 2001The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration3,828 cited
  • 2007Mediators and Mechanisms of Change in Psychotherapy Research2,503 cited
  • 2015How important are the common factors in psychotherapy? An update1,725 cited
  • 1999The heart and soul of change: What works in therapy.1,400 cited
  • 2001Behavioral Activation Treatment for Depression: Returning to Contextual Roots1,010 cited
  • 1999The empirical case for the common factors in therapy: Quantitative findings.743 cited
  • 2017Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms691 cited
  • 2012A Randomized, Placebo-Controlled Trial of Online Cognitive Behavioral Therapy for Chronic Insomnia Disorder Delivered via an Automated Media-Rich Web Application551 cited
  • 1973Pleasant activities and depression.539 cited
  • 2004Blinding was judged more difficult to achieve and maintain in nonpharmacologic than pharmacologic trials300 cited
  • 2016The digital placebo effect: mobile mental health meets clinical psychiatry200 cited
  • 2016Form of delivery as a key ‘active ingredient’ in behaviour change interventions168 cited
  • 2019Digital mental health apps and the therapeutic alliance: initial review

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152 cited
  • 2021Banbury Forum Consensus Statement on the Path Forward for Digital Mental Health Treatment115 cited
  • 2019Clinically Meaningful Use of Mental Health Apps and its Effects on Depression: Mixed Methods Study91 cited
  • Cited by

    • 2023Digital therapeutics in the clinic86 cited
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    • 2024Exploring the potential of digital therapeutics: An assessment of progress and promise35 cited
    • 2025Analyzing metaverse-based digital therapies, their effectiveness, and potential risks in mental healthcare35 cited
    • 2023Economic Evaluation Associated With Clinical-Grade Mobile App–Based Digital Therapeutic Interventions: Systematic Review30 cited
    • 2023Challenges With the Use of Digital Sham: Systematic Review and Recommendations28 cited
    • 2024Elderly patients' reactions to gamification-based digital therapeutics (DTx): The relevance of socialization tendency seeking23 cited
    • 2023Digital Therapeutics as a New Therapeutic Modality: A Review from the Perspective of Clinical Pharmacology17 cited
    • 2025A digital therapeutic (CT-152) as adjunct to antidepressant medication: A phase 3 randomized controlled trial (the Mirai study)14 cited
    • 2024Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study12 cited
    • 2023Systematic Review of Extended Reality Digital Therapy for Enhancing Mental Health Among South Korean Adolescents and Young Adults11 cited
    • 2025From awareness to integration: a qualitative interview study on the impact of digital therapeutics on physicians’ practices in Germany10 cited
    • 2025Feasibility of a digital therapeutic for experiential negative symptoms of schizophrenia: results from an exploratory study9 cited
    • 2023Use and Engagement With Low-Intensity Cognitive Behavioral Therapy Techniques Used Within an App to Support Worry Management: Content Analysis of Log Data8 cited
    • 2024Self-help digital mental health intervention in improving burnout and mental health outcomes among healthcare workers: A narrative review8 cited
    • 2025Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies6 cited