GGZ NHN
Alkmaar, North Holland, 1817 EX, Netherlands
Location status: Recruiting
Location contact
Elles te Brake, MSc
CONTACT
Eva Velthorst, PhD
CONTACT
NCT Number: NCT06617663
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.
Interested in participating?
Request Info12 year–18 year
All sexes
Interventional
Not applicable
Alkmaar, North Holland, 1817 EX, Netherlands
Location status: Recruiting
Elles te Brake, MSc
CONTACT
Eva Velthorst, PhD
CONTACT
In recent years, there has been tension between young people's need for specialty mental health care (sGGZ) and the lack of sufficient available resources and staff. As a result, waiting lists have increased. To increase the accessibility and efficiency of care, online treatment through video calling is a promising method. Online treatment can help reduce waiting lists, as there are no limitations in terms of physical space and geographical proximity to clients and health care professionals, and it allows mental health professionals to work more efficiently and reach more young people, as they have no travel time and can plan flexibly from any location. An additional advantage of online treatment is its low threshold. Young people with mental health problems often face stigma and shame for physically going to a mental health facility. Online treatment via video call can remove this barrier and allow young people to access the care they need from their familiar surroundings.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eye Movement Desensitization and Reprocessing (EMDR) is a therapy designed to alleviate the distress associated with traumatic memories.
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.
Time frame: At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)
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.
Time frame: At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)
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.
Time frame: At baseline, +/- 3-months within treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)
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.
Time frame: At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)
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
Time frame: At +/- 1 1/2 month after start treatment
The WAV-12 will be used to examine whether there is a significant difference in therapeutic alliance between treatments performed on site and online. The minimum score of the WAV-12 , the maximum score is 60. A high score reflects a better therapeutic bond
Contact information is provided by the study sponsor or research team.
Elles te Brake, Msc
CONTACT
Eva Velthorst, PhD
CONTACT
GGZ Noord-Holland-Noord
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04725721
Anxiety, Anxiety Disorders
Cambridge, Massachusetts, United States
View Trial DetailsNCT07251478
Anxiety, Anxiety Disorders
View Trial DetailsNCT06628518
Anxiety, Anxiety Disorders
View Trial DetailsNCT06064578
Anxiety, Anxiety Disorders
Cambridge, Massachusetts, United States
View Trial Details