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Preregistration

Informed Consent for Psychotherapy: A Randomized Controlled Trial evaluating the Efficacy of an Optimized Informed Consent on Treatment Expectations and Capacity to Consent

Author(s) / Creator(s)

Gerke, Leonie
Ladwig, Sönke
Pauls, Franz
Härter, Martin
Nestoriuc, Yvonne

Abstract / Description

Informed consent is a legal and ethical prerequisite for conducting psychotherapy. However, the informed consent for psychotherapy still seems to play a minor role in daily practice. The aim of the present study is to evaluate the efficacy of a newly developed optimized informed consent consultation for psychotherapy (OIC) in a randomized controlled online trial. N=122 adults with indication for psychotherapy will be recruited. After baseline assessment (t0), participants will be randomly assigned either to a control group receiving an information brochure as treatment as usual (TAU) or to the intervention group receiving the OIC in addition to TAU. OIC and post-assessment will take place at the second online study visit (t1; 2 weeks following t0). Two weeks and three months after t1, participants will receive online follow-up questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include capacity to consent, decisional conflicts, autonomous treatment motivation, and adherence intention.
This is a preregistration of the article: Gerke, L., Ladwig, S., Pauls, F., Trachsel, M., Härter, M., & Nestoriuc, Y. (2022). Optimized Informed Consent for Psychotherapy: Protocol for a Randomized Controlled Trial. JMIR Research Protocols, 11(9). https://doi.org/10.2196/39843

Keyword(s)

counselling shared-decision making risks and side effects of psychotherapy expectation management ethics placebo effect nocebo effect outpatient psychotherapy

Persistent Identifier

PsychArchives acquisition timestamp

2021-06-17 11:37:39 UTC

Publisher

PsychArchives

Citation

Gerke, L., Ladwig, S., Pauls, F., Härter, M., & Nestoriuc, Y. (2021). Informed Consent for Psychotherapy: A Randomized Controlled Trial evaluating the Efficacy of an Optimized Informed Consent on Treatment Expectations and Capacity to Consent. PsychArchives. https://doi.org/10.23668/PSYCHARCHIVES.4929
  • Author(s) / Creator(s)
    Gerke, Leonie
  • Author(s) / Creator(s)
    Ladwig, Sönke
  • Author(s) / Creator(s)
    Pauls, Franz
  • Author(s) / Creator(s)
    Härter, Martin
  • Author(s) / Creator(s)
    Nestoriuc, Yvonne
  • PsychArchives acquisition timestamp
    2021-06-17T11:37:39Z
  • Made available on
    2021-06-17T11:37:39Z
  • Date of first publication
    2021-06-17
  • Abstract / Description
    Informed consent is a legal and ethical prerequisite for conducting psychotherapy. However, the informed consent for psychotherapy still seems to play a minor role in daily practice. The aim of the present study is to evaluate the efficacy of a newly developed optimized informed consent consultation for psychotherapy (OIC) in a randomized controlled online trial. N=122 adults with indication for psychotherapy will be recruited. After baseline assessment (t0), participants will be randomly assigned either to a control group receiving an information brochure as treatment as usual (TAU) or to the intervention group receiving the OIC in addition to TAU. OIC and post-assessment will take place at the second online study visit (t1; 2 weeks following t0). Two weeks and three months after t1, participants will receive online follow-up questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include capacity to consent, decisional conflicts, autonomous treatment motivation, and adherence intention.
    en
  • Abstract / Description
    This is a preregistration of the article: Gerke, L., Ladwig, S., Pauls, F., Trachsel, M., Härter, M., & Nestoriuc, Y. (2022). Optimized Informed Consent for Psychotherapy: Protocol for a Randomized Controlled Trial. JMIR Research Protocols, 11(9). https://doi.org/10.2196/39843
    en
  • Publication status
    other
    en
  • Review status
    unknown
    en
  • Citation
    Gerke, L., Ladwig, S., Pauls, F., Härter, M., & Nestoriuc, Y. (2021). Informed Consent for Psychotherapy: A Randomized Controlled Trial evaluating the Efficacy of an Optimized Informed Consent on Treatment Expectations and Capacity to Consent. PsychArchives. https://doi.org/10.23668/PSYCHARCHIVES.4929
    en
  • Persistent Identifier
    https://hdl.handle.net/20.500.12034/4357
  • Persistent Identifier
    https://doi.org/10.23668/psycharchives.4929
  • Language of content
    eng
  • Publisher
    PsychArchives
    en
  • Is related to
    https://doi.org/10.2196/39843
  • Keyword(s)
    counselling
    en
  • Keyword(s)
    shared-decision making
    en
  • Keyword(s)
    risks and side effects of psychotherapy
    en
  • Keyword(s)
    expectation management
    en
  • Keyword(s)
    ethics
    en
  • Keyword(s)
    placebo effect
    en
  • Keyword(s)
    nocebo effect
    en
  • Keyword(s)
    outpatient psychotherapy
    en
  • Dewey Decimal Classification number(s)
    150
  • Title
    Informed Consent for Psychotherapy: A Randomized Controlled Trial evaluating the Efficacy of an Optimized Informed Consent on Treatment Expectations and Capacity to Consent
    en
  • DRO type
    preregistration
    en
  • Visible tag(s)
    PRP-QUANT
    en