跳至主要内容
临床试验/NCT06617663
NCT06617663招募中不适用

Online Therapy Youth, Equivalent to Treatment As Usual?

GGZ Noord-Holland-Noord2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
172
试验地点
2
主要终点
Change in the level of psychological flexibility (for the ACT arms), as measured by the AFQ-Y.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

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.

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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

次要结局

  • Differences in the therapeutic relationship, as measured by the WAV-12 (work alliance questionnaire)(At +/- 1 1/2 month after start treatment)

研究者

发起方
GGZ Noord-Holland-Noord
申办方类型
Other
责任方
Sponsor

研究点 (2)

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