Online Therapy Youth, Equivalent to Treatment As Usual?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorGGZ Noord-Holland-Noord
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Clients who are crisis-prone or enter in crisis
Clients who are in forced care (wvggz)
Trial design
Design model
Parallel
Treatments tested in this trial
EMDR
BehavioralEye Movement Desensitization and Reprocessing (EMDR) is a therapy designed to alleviate the distress associated with traumatic memories.
ACT
BehavioralAcceptance 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.
Treatment groups
172 Participants
are divided into 4 treatment groupsGroup A: EMDR onlineExperimental treatment 1 intervention
Group B: EMDR on-siteActive comparator 1 intervention
Group C: ACT onlineExperimental treatment 1 intervention
Group D: ACT on-siteActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)2
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.
Time frame
At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)3
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.
Time frame
At baseline, +/- 3-months within treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)4
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
Time frame
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)
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
Time frame
At +/- 1 1/2 month after start treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
GGZ Noord-Holland-Noord
Lead sponsor
UMC Utrecht
Collaborator
Source ClinicalTrials.gov