Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder: study protocol for a multicenter randomized controlled trial (IMPROVE) (2024)

Abstract

Background: Exposure-based therapy is the treatment of choice for anxiety disorders, but many patients do not benefit sufficiently from it. Distressing images of threat related to the future or past may maintain the anxiety symptomatology or impede exposure therapy. An intervention that targets threat-related imagery is eye movement desensitization and reprocessing (EMDR) therapy. The main goal of this multicenter randomized controlled trial is to investigate whether EMDR therapy plus exposure therapy, relative to supportive counseling plus exposure therapy, improves treatment efficacy, tolerability, and adherence in patients with panic disorder. In addition, we will examine potential predictors of optimal treatment allocation, mechanisms of change as well as the long term effects of treatment. Finally, we will assess cost-effectiveness.

Methods: A multicenter randomized controlled trial mixed design will be conducted. Participants will be 50 patients, aged ≥ 18, diagnosed with a panic disorder. They will be randomly assigned to one of two conditions: EMDR therapy (i.e., flashforward strategy) or supportive counseling (each consisting of four weekly sessions of 90min each) prior to exposure therapy (consisting of eight weekly sessions of 90min each). Assessments will be made pre-treatment (T1), between-treatments (T2), post-treatment (T3), one month post-treatment (FU1) and six months post-treatment (FU2) by an assessor blind to treatment condition. The primary outcome measure is severity of panic-related symptoms. Secondary outcome measures are: tolerability of exposure therapy (initial avoidance, willingness to start exposure therapy, considered drop-out; no-show and drop-out), related symptomatology (generalized anxiety, depression), and functional impairment.

Discussion: The primary goals of this research are to compare the efficacy, tolerability, and adherence of EMDR therapy plus exposure therapy and supportive counseling plus exposure therapy and to identify predictors, moderators, and mediators for treatment success. This multi-center research aims to make a significant contribution to our understanding as to how treatment for patients with anxiety disorders can be optimized, and elucidate who can benefit most from this novel approach.

Trial registration: ISRCTN—ISRCTN29668369: Improving anxiety treatment by modifying emotional memories before real-life exposure. Registered 27 June 2022—retrospectively registered. ISRCTN—ISRCTN29668369.

Original languageEnglish
Article number157
Number of pages16
JournalBMC Psychiatry
Volume23
Issue number1
DOIs
Publication statusPublished - 14 Mar 2023

Keywords

  • Anxiety Disorder
  • Cognitive-Behavioral Therapy (CBT)
  • Exposure Therapy
  • Eye Movement Desensitization and Reprocessing (EMDR) therapy
  • Panic Disorder
  • Randomized Controlled Trial
  • Supportive Counseling

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    Endhoven, B., De Cort, K., Matthijssen, S. J. M. A., de Jongh, A., van Minnen, A., Duits, P., Schruers, K. R. J., van Dis, E. A. M., Krypotos, A. M., Gerritsen, L. (2023). Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder: study protocol for a multicenter randomized controlled trial (IMPROVE). BMC Psychiatry, 23(1), Article 157. https://doi.org/10.1186/s12888-022-04320-4

    Endhoven, B. ; De Cort, K. ; Matthijssen, S.J.M.A. et al. / Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder : study protocol for a multicenter randomized controlled trial (IMPROVE). In: BMC Psychiatry. 2023 ; Vol. 23, No. 1.

    @article{b48f6bb05c7340818c87ecfb3f635722,

    title = "Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder: study protocol for a multicenter randomized controlled trial (IMPROVE)",

    abstract = "Background: Exposure-based therapy is the treatment of choice for anxiety disorders, but many patients do not benefit sufficiently from it. Distressing images of threat related to the future or past may maintain the anxiety symptomatology or impede exposure therapy. An intervention that targets threat-related imagery is eye movement desensitization and reprocessing (EMDR) therapy. The main goal of this multicenter randomized controlled trial is to investigate whether EMDR therapy plus exposure therapy, relative to supportive counseling plus exposure therapy, improves treatment efficacy, tolerability, and adherence in patients with panic disorder. In addition, we will examine potential predictors of optimal treatment allocation, mechanisms of change as well as the long term effects of treatment. Finally, we will assess cost-effectiveness. Methods: A multicenter randomized controlled trial mixed design will be conducted. Participants will be 50 patients, aged ≥ 18, diagnosed with a panic disorder. They will be randomly assigned to one of two conditions: EMDR therapy (i.e., flashforward strategy) or supportive counseling (each consisting of four weekly sessions of 90min each) prior to exposure therapy (consisting of eight weekly sessions of 90min each). Assessments will be made pre-treatment (T1), between-treatments (T2), post-treatment (T3), one month post-treatment (FU1) and six months post-treatment (FU2) by an assessor blind to treatment condition. The primary outcome measure is severity of panic-related symptoms. Secondary outcome measures are: tolerability of exposure therapy (initial avoidance, willingness to start exposure therapy, considered drop-out; no-show and drop-out), related symptomatology (generalized anxiety, depression), and functional impairment. Discussion: The primary goals of this research are to compare the efficacy, tolerability, and adherence of EMDR therapy plus exposure therapy and supportive counseling plus exposure therapy and to identify predictors, moderators, and mediators for treatment success. This multi-center research aims to make a significant contribution to our understanding as to how treatment for patients with anxiety disorders can be optimized, and elucidate who can benefit most from this novel approach. Trial registration: ISRCTN—ISRCTN29668369: Improving anxiety treatment by modifying emotional memories before real-life exposure. Registered 27 June 2022—retrospectively registered. ISRCTN—ISRCTN29668369.",

    keywords = "Anxiety Disorder, Cognitive-Behavioral Therapy (CBT), Exposure Therapy, Eye Movement Desensitization and Reprocessing (EMDR) therapy, Panic Disorder, Randomized Controlled Trial, Supportive Counseling",

    author = "B. Endhoven and {De Cort}, K. and S.J.M.A. Matthijssen and {de Jongh}, A. and {van Minnen}, A. and P. Duits and K.R.J. Schruers and {van Dis}, E.A.M. and A.M. Krypotos and L. Gerritsen and I.M. Engelhard",

    note = "Funding Information: The IMPROVE-study is funded by a VICI grant for innovational research (453–15-005) awarded to Prof. dr. Iris Engelhard by the Dutch Research Council (NWO). The sponsor (NWO) had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. As part of the funding process, the sponsor peer-reviewed the study protocol. The funding body The sponsor promotes open science and knowledge utilization. NWO: P.O. Box 93138, 2509AC The Hague, https://www.nwo.nl/ Funding Information: We would like to thank all patients, therapists, supervisors and research assistants who will participate in the study. We appreciate advice given by our consultants, prof. dr. Marcel van den Hout and prof. dr. Rens van de Schoot. Additionally, we thank the management of Altrecht and Mondriaan for enabling the implementation of the study in the treatment centers. Finally, we thank Suzanne van Veen for her involvement in the conceptualization and design of the study, and Carmen van den Bulck and Sanne Beishuizen for coordinating the study as research assistants. Publisher Copyright: {\textcopyright} 2023, The Author(s).",

    year = "2023",

    month = mar,

    day = "14",

    doi = "10.1186/s12888-022-04320-4",

    language = "English",

    volume = "23",

    journal = "BMC Psychiatry",

    issn = "1471-244X",

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    number = "1",

    }

    Endhoven, B, De Cort, K, Matthijssen, SJMA, de Jongh, A, van Minnen, A, Duits, P, Schruers, KRJ, van Dis, EAM, Krypotos, AM, Gerritsen, L 2023, 'Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder: study protocol for a multicenter randomized controlled trial (IMPROVE)', BMC Psychiatry, vol. 23, no. 1, 157. https://doi.org/10.1186/s12888-022-04320-4

    Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder: study protocol for a multicenter randomized controlled trial (IMPROVE). / Endhoven, B.; De Cort, K.; Matthijssen, S.J.M.A. et al.
    In: BMC Psychiatry, Vol. 23, No. 1, 157, 14.03.2023.

    Research output: Contribution to journalArticleAcademicpeer-review

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    T1 - Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder

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    AU - Endhoven, B.

    AU - De Cort, K.

    AU - Matthijssen, S.J.M.A.

    AU - de Jongh, A.

    AU - van Minnen, A.

    AU - Duits, P.

    AU - Schruers, K.R.J.

    AU - van Dis, E.A.M.

    AU - Krypotos, A.M.

    AU - Gerritsen, L.

    AU - Engelhard, I.M.

    N1 - Funding Information:The IMPROVE-study is funded by a VICI grant for innovational research (453–15-005) awarded to Prof. dr. Iris Engelhard by the Dutch Research Council (NWO). The sponsor (NWO) had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results. As part of the funding process, the sponsor peer-reviewed the study protocol. The funding body The sponsor promotes open science and knowledge utilization. NWO: P.O. Box 93138, 2509AC The Hague, https://www.nwo.nl/ Funding Information:We would like to thank all patients, therapists, supervisors and research assistants who will participate in the study. We appreciate advice given by our consultants, prof. dr. Marcel van den Hout and prof. dr. Rens van de Schoot. Additionally, we thank the management of Altrecht and Mondriaan for enabling the implementation of the study in the treatment centers. Finally, we thank Suzanne van Veen for her involvement in the conceptualization and design of the study, and Carmen van den Bulck and Sanne Beishuizen for coordinating the study as research assistants.Publisher Copyright:© 2023, The Author(s).

    PY - 2023/3/14

    Y1 - 2023/3/14

    N2 - Background: Exposure-based therapy is the treatment of choice for anxiety disorders, but many patients do not benefit sufficiently from it. Distressing images of threat related to the future or past may maintain the anxiety symptomatology or impede exposure therapy. An intervention that targets threat-related imagery is eye movement desensitization and reprocessing (EMDR) therapy. The main goal of this multicenter randomized controlled trial is to investigate whether EMDR therapy plus exposure therapy, relative to supportive counseling plus exposure therapy, improves treatment efficacy, tolerability, and adherence in patients with panic disorder. In addition, we will examine potential predictors of optimal treatment allocation, mechanisms of change as well as the long term effects of treatment. Finally, we will assess cost-effectiveness. Methods: A multicenter randomized controlled trial mixed design will be conducted. Participants will be 50 patients, aged ≥ 18, diagnosed with a panic disorder. They will be randomly assigned to one of two conditions: EMDR therapy (i.e., flashforward strategy) or supportive counseling (each consisting of four weekly sessions of 90min each) prior to exposure therapy (consisting of eight weekly sessions of 90min each). Assessments will be made pre-treatment (T1), between-treatments (T2), post-treatment (T3), one month post-treatment (FU1) and six months post-treatment (FU2) by an assessor blind to treatment condition. The primary outcome measure is severity of panic-related symptoms. Secondary outcome measures are: tolerability of exposure therapy (initial avoidance, willingness to start exposure therapy, considered drop-out; no-show and drop-out), related symptomatology (generalized anxiety, depression), and functional impairment. Discussion: The primary goals of this research are to compare the efficacy, tolerability, and adherence of EMDR therapy plus exposure therapy and supportive counseling plus exposure therapy and to identify predictors, moderators, and mediators for treatment success. This multi-center research aims to make a significant contribution to our understanding as to how treatment for patients with anxiety disorders can be optimized, and elucidate who can benefit most from this novel approach. Trial registration: ISRCTN—ISRCTN29668369: Improving anxiety treatment by modifying emotional memories before real-life exposure. Registered 27 June 2022—retrospectively registered. ISRCTN—ISRCTN29668369.

    AB - Background: Exposure-based therapy is the treatment of choice for anxiety disorders, but many patients do not benefit sufficiently from it. Distressing images of threat related to the future or past may maintain the anxiety symptomatology or impede exposure therapy. An intervention that targets threat-related imagery is eye movement desensitization and reprocessing (EMDR) therapy. The main goal of this multicenter randomized controlled trial is to investigate whether EMDR therapy plus exposure therapy, relative to supportive counseling plus exposure therapy, improves treatment efficacy, tolerability, and adherence in patients with panic disorder. In addition, we will examine potential predictors of optimal treatment allocation, mechanisms of change as well as the long term effects of treatment. Finally, we will assess cost-effectiveness. Methods: A multicenter randomized controlled trial mixed design will be conducted. Participants will be 50 patients, aged ≥ 18, diagnosed with a panic disorder. They will be randomly assigned to one of two conditions: EMDR therapy (i.e., flashforward strategy) or supportive counseling (each consisting of four weekly sessions of 90min each) prior to exposure therapy (consisting of eight weekly sessions of 90min each). Assessments will be made pre-treatment (T1), between-treatments (T2), post-treatment (T3), one month post-treatment (FU1) and six months post-treatment (FU2) by an assessor blind to treatment condition. The primary outcome measure is severity of panic-related symptoms. Secondary outcome measures are: tolerability of exposure therapy (initial avoidance, willingness to start exposure therapy, considered drop-out; no-show and drop-out), related symptomatology (generalized anxiety, depression), and functional impairment. Discussion: The primary goals of this research are to compare the efficacy, tolerability, and adherence of EMDR therapy plus exposure therapy and supportive counseling plus exposure therapy and to identify predictors, moderators, and mediators for treatment success. This multi-center research aims to make a significant contribution to our understanding as to how treatment for patients with anxiety disorders can be optimized, and elucidate who can benefit most from this novel approach. Trial registration: ISRCTN—ISRCTN29668369: Improving anxiety treatment by modifying emotional memories before real-life exposure. Registered 27 June 2022—retrospectively registered. ISRCTN—ISRCTN29668369.

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    KW - Eye Movement Desensitization and Reprocessing (EMDR) therapy

    KW - Panic Disorder

    KW - Randomized Controlled Trial

    KW - Supportive Counseling

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    Endhoven B, De Cort K, Matthijssen SJMA, de Jongh A, van Minnen A, Duits P et al. Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder: study protocol for a multicenter randomized controlled trial (IMPROVE). BMC Psychiatry. 2023 Mar 14;23(1):157. doi: 10.1186/s12888-022-04320-4

    Eye movement desensitization and reprocessing (EMDR) therapy or supportive counseling prior to exposure therapy in patients with panic disorder: study protocol for a multicenter randomized controlled trial (IMPROVE) (2024)
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