Online Therapy Youth, Equivalent to Treatment As Usual?

NCT06617663 | Recruiting DMC

• 1 other identifier: GGZNHNETB2024
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

With growing waiting lists in specialized youth mental health care (sGGZ) and shortages of care staff, finding creative solutions to respond to this scarcity issue is important. Online treatment is an example of this, which, especially for young people growing up in a digital age, can be an appropriate and accessible alternative to treatment at a physical location. Online treatment via video calling among youth, while researched and proven effective in a blended form, has not yet been sufficiently researched as a complete replacement for treatment at a physical location. As a result, the potential added value of online treatment for the pressing scarcity issue in healthcare is not yet sufficiently clear. 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.

Conditions

Depression; Trauma; Compulsive Disorder; Anxiety; Unexplained Symptom, Medically

Keywords

EMDR intervention; ACT internvention; youth 12.18

Outcome Measures

Primary Outcomes (4)

• Change in the level of psychological flexibility (for the ACT arms), as measured by the AFQ-Y.

  Differences in psychological flexibility between individuals that receive ACT online and on-site will be measured wit the AFQ-Y. The scale has a minimum score of 0 and a maximum score of 68. A higher score indicates a greater psychological inflexibility.

  At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)

• Change in the degree of overall symptomatic distress, as measured by the Youth Outcome questionnaire (YOQ)

  Differences in symptomatic distress between treatments performed on site and those performed online will be measured with the YOQ. The questionnaire has a minimum score of 0 and a maximum score of 120. A higher scores indicate a greater level of distress.

  At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)

• Change in post-traumatic symptoms (for the EMDR arms), as measured by the KJTS EMDR questionnaire

  Differences in posttraumatic stress symptoms between individuals that receive EMDR treatment on site and online will be measured with the KJTS EMDR. KJTS has a minimum score of 0 and a maximum score of 60. A higher score indicates more symptoms.

  At baseline, +/- 3-months within treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)

• Change in the degree of societal recovery, as measured by the kidsscreen-27.

  It will be measured whether there is a significant difference in societal functioning between individuals who receive treatment on site and online. Minimum score is 27, maximum score is 135. Higher score indicates better societal functioning

  At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)

Secondary Outcomes (1)

• Differences in the therapeutic relationship, as measured by the WAV-12 (work alliance questionnaire)

  At +/- 1 1/2 month after start treatment

Study Arms (4)

EMDR online

EXPERIMENTAL

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.

Behavioral: EMDR

EMDR on-site

ACTIVE COMPARATOR

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.

Behavioral: EMDR

ACT online

EXPERIMENTAL

ACT, along with an e-health program, will be offered through video conferencing.

Behavioral: ACT

ACT on-site

ACTIVE COMPARATOR

ACT will be offered at a physical location without additional e-health modules.

Behavioral: ACT

Interventions

EMDR BEHAVIORAL

Eye Movement Desensitization and Reprocessing (EMDR) is a therapy designed to alleviate the distress associated with traumatic memories.

EMDR on-site; EMDR online

ACT BEHAVIORAL

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 online

Eligibility Criteria

• Age: 12 Years - 18 Years
• Gender Eligibility Details: Male, female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged 12-18 years who would benefit from ACT or EMDR within the SGGZ, as determined by the screeners at registration or current primary practitioner.
• 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

You may not qualify if:

• Clients who are crisis-prone or enter in crisis
• Clients who are in forced care (wvggz)

Sponsors & Collaborators

• GGZ Noord-Holland-Noord: lead
• UMC Utrecht: collaborator

Study Sites (1)

GGZ NHN

Alkmaar, North Holland, 1817 EX, Netherlands

RECRUITING

Related Publications (10)

• 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.

  PMID: 34948601 BACKGROUND

• 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.

  PMID: 17668292 BACKGROUND

• 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

  BACKGROUND

• Pelzer, A. et al (2022), K. De balans is zoek in Jeugdzorgland. Kind Adolesc Prakt 21, 34-36

  BACKGROUND

• 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.

  PMID: 27837935 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• caleidoZorg & CZ (2023) Tijd effectiviteit van WeMind vs. Lightbar bij EMDR-therapie in een klinische populatie

  BACKGROUND

• Swain, J. et al (2015). Acceptance and Commitment Therapy for children: A systematic review of intervention studies.

  BACKGROUND

• Brake ET, Scheepers F, Mous T, Visser I, Vernhout S, Velthorst E. Comparing the effectiveness of online therapy versus in-person therapy in youth: protocol for a non-inferiority randomized controlled trial. Trials. 2025 Dec 1;27(1):3. doi: 10.1186/s13063-025-09312-9.

  PMID: 41327248 DERIVED

MeSH Terms

Conditions

Depression; Wounds and Injuries; Compulsive Personality Disorder; Anxiety Disorders; Medically Unexplained Symptoms

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personality Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Elles te Brake, Msc

CONTACT

0031623942414; e.tebrake@ggz-nhn.nl

Eva Velthorst, PhD

CONTACT

0031618644345; e.velthorst@ggz-nhn.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Block randomization will be conducted by an independent researcher who is not involved in the study assessments or therapies. This process will assign clients to either online or in-patient treatment to ensure approximately equal distributions of individuals aged 12-15 and 15-18, as well as balanced representation of different sexes. For both video call treatment and treatment at a physical location, the waiting time until the start of treatment will be the same; treatment will begin within a maximum of 2 months from registration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized non-inferiority design will be used to demonstrate whether or not online treatment is inferior to treatment as usual (TAU). Data will be analyzed according to the intention-to-treat principle, with all randomized clients included in the analysis, as well as \"per protocol\" (where a minimum of 12 sessions must be completed). 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.

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: September 27, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-08

Locations

NL (1)