Online Therapy Youth, Equivalent to Treatment As Usual?
NCT ID: NCT06617663
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
172 participants
INTERVENTIONAL
2024-07-01
2026-09-01
Brief Summary
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This study therefore focuses on investigating the effectiveness of fully online treatment using two proven effective interventions: Eye Movement Desensitization and Reprocessing (EMDR) and Acceptance and Commitment Therapy (ACT) within the youth sGGZ. With the results of this research at GGZ-NHN, the investigators want to contribute to the development of guidelines and standards for the implementation of online treatments within Dutch youth mental health care.
Detailed Description
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It is plausible that fully online treatment with youth is at least as effective as treatment in a physical location, regardless of cultural origin, gender, or social environment, because youth are familiar with digital communication, the technical application has now been sufficiently developed, and blended treatment has been assessed as effective in research. However, it has not yet been sufficiently scientifically studied whether fully online treatment via video calling in youth is actually a worthy alternative to physical treatment in reducing mental health problems among youth.
This research project of GGZ Noord-Holland-Noord (GGZ-NHN), on which Drs. E. te Brake will receive her doctorate, therefore focuses on the effectiveness of fully online treatment within the youth sGGZ compared to regular treatment at a physical location. This study explicitly includes a role for experts by experience who, from the perspective of clients and relatives, contribute to the design and execution of the study and the implementation of the results into treatment practice.
The proposed research includes a Randomized Controlled Trial (RCT), specifically focused on two common therapies with adolescents in the sGGZ: Acceptance and Commitment Therapy (ACT) and Eye Movement Desensitization and Reprocessing (EMDR). Cognitive behavior therapy (CBT) could be an obvious choice because of its extensive knowledge and experience, as well as available scientific evidence. But the investigators prefer the more generalist ACT because CBT uses a separate protocol for each target group. As a third-generation form of therapy, ACT is a suitable intervention because its universal protocol is applicable to a broad target group. Moreover, ACT has been shown to be not inferior to cognitive behavioral therapy in terms of effectiveness. The methodology shows significant improvements in depressive symptoms, quality of life, and perception of competence.
Treatment will be protocolized according to the guidelines prescribed by the manual for this purpose. The protocol used is specifically intended for the target group aged 15-25. However, it is known that adolescents between 12 and 15 can also benefit well from ACT. Age-appropriate adjustments in language use will be applied here. In addition, EMDR will be investigated for trauma-specific symptoms, as digital tools are available with EMDR that allow for a good comparison with EMDR in a physical location.
Because an RCT generates reliable and generalizable information, and the investigators examine two commonly used interventions in the mental health system, the study fits well with policymakers' effectiveness-evidence criteria. If it turns out that fully online treatment is a worthy alternative to treatment at a physical location, then this lays a foundation for online work. It thus contributes to the low threshold, accessibility, and affordability of youth mental health care.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
In both the intention-to-treat and \"per protocol\" analyses, mixed general linear (or nonlinear, depending on score distribution) models will be performed, where the main effect of treatment and the interaction between effect and treatment setting are our main measures of interest. Mixed models have the advantage that they 1) account for multiple measures within the same individual, and 2) account for missing values. All analyses are adjusted for baseline value on the outcome measure, gender, and age. To detect age- and gender-specific effects, analyses will also be performed separately by gender and age group.
TREATMENT
DOUBLE
Study Groups
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EMDR online
The investigators will use the Association for EMDR (called VEN in the Netherlands) protocol for individuals up to age 18 through videoconferencing with a therapist, supported by MOOVD as a digital intervention platform.
EMDR
Eye Movement Desensitization and Reprocessing (EMDR) is a therapy designed to alleviate the distress associated with traumatic memories.
EMDR on-site
The investigators will use the Association for EMDR (called VEN in the Netherlands) protocol for individuals up to age 18 at a physical location . Various working memory load techniques may be used, including the light bar.
EMDR
Eye Movement Desensitization and Reprocessing (EMDR) is a therapy designed to alleviate the distress associated with traumatic memories.
ACT online
ACT, along with an e-health program, will be offered through video conferencing.
ACT
Acceptance and Commitment Therapy (ACT) is an action-oriented approach to psychotherapy that stems from traditional behavior therapy and cognitive behavioral therapy. Clients learn to stop avoiding, denying, and struggling with their inner emotions and, instead, accept that these deeper feelings are appropriate responses to certain situations and should not prevent them from moving forward in their lives. The ACT Your Way method is specifically designed for young people.
ACT on-site
ACT will be offered at a physical location without additional e-health modules.
ACT
Acceptance and Commitment Therapy (ACT) is an action-oriented approach to psychotherapy that stems from traditional behavior therapy and cognitive behavioral therapy. Clients learn to stop avoiding, denying, and struggling with their inner emotions and, instead, accept that these deeper feelings are appropriate responses to certain situations and should not prevent them from moving forward in their lives. The ACT Your Way method is specifically designed for young people.
Interventions
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EMDR
Eye Movement Desensitization and Reprocessing (EMDR) is a therapy designed to alleviate the distress associated with traumatic memories.
ACT
Acceptance and Commitment Therapy (ACT) is an action-oriented approach to psychotherapy that stems from traditional behavior therapy and cognitive behavioral therapy. Clients learn to stop avoiding, denying, and struggling with their inner emotions and, instead, accept that these deeper feelings are appropriate responses to certain situations and should not prevent them from moving forward in their lives. The ACT Your Way method is specifically designed for young people.
Eligibility Criteria
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Inclusion Criteria
* Client is stable, i.e. there is no serious crisis (to be determined by screener cq primary practitioner)
* Sufficient command of the Dutch language to complete the questionnaires.
* Client does not participate in other (intervention) studies
Exclusion Criteria
* Clients who are in forced care (wvggz)
12 Years
18 Years
ALL
Yes
Sponsors
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UMC Utrecht
OTHER
GGZ Noord-Holland-Noord
OTHER
Responsible Party
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Locations
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GGZ NHN
Alkmaar, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Elles te Brake, MSc
Role: primary
Eva Velthorst, PhD
Role: backup
References
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Midgley N, Guerrero-Tates B, Mortimer R, Edbrooke-Childs J, Mechler J, Lindqvist K, Hajkowski S, Leibovich L, Martin P, Andersson G, Vlaescu G, Lilliengren P, Kitson A, Butler-Wheelhouse P, Philips B. The Depression: Online Therapy Study (D:OTS)-A Pilot Study of an Internet-Based Psychodynamic Treatment for Adolescents with Low Mood in the UK, in the Context of the COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Dec 9;18(24):12993. doi: 10.3390/ijerph182412993.
Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, Power M, Duer W, Cloetta B, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007 Oct;16(8):1347-56. doi: 10.1007/s11136-007-9240-2. Epub 2007 Aug 1.
Porter CM, Galloghly E, Burbach FR. The effective delivery of digital CBT: a service evaluation exploring the outcomes of young people who completed video conferencing therapy in 2020. The Cognitive Behaviour Therapist. 2022;15:e27. doi:10.1017/S1754470X22000216
Pelzer, A. et al (2022), K. De balans is zoek in Jeugdzorgland. Kind Adolesc Prakt 21, 34-36
Schueller SM, Stiles-Shields C, Yarosh L. Online Treatment and Virtual Therapists in Child and Adolescent Psychiatry. Child Adolesc Psychiatr Clin N Am. 2017 Jan;26(1):1-12. doi: 10.1016/j.chc.2016.07.011. Epub 2016 Oct 15.
Stinckens, Nele & Ulburghs, A. & Claes, Laurence. (2009). De werkalliantie als sleutelelement in het therapiegebeuren: Meting met behulp van de WAV-12, de Nederlandstalige verkorte versie van de Working Alliance Inventory. Tijdschrift Klinische Psychologie. 39. 44-60.
Schraven, J., et al. (2023) ACT your way, kwaliteit van het protocol en eerste bevindingen van een pilot- effectonderzoek bij adolescenten met een recidiverende depressie
caleidoZorg & CZ (2023) Tijd effectiviteit van WeMind vs. Lightbar bij EMDR-therapie in een klinische populatie
Swain, J. et al (2015). Acceptance and Commitment Therapy for children: A systematic review of intervention studies.
Other Identifiers
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GGZNHNETB2024
Identifier Type: -
Identifier Source: org_study_id