DepressionNCT06617663
Online Therapy Youth, Equivalent to Treatment As Usual?
A study testing EMDR and ACT in people with Depression and Trauma, run by GGZ Noord-Holland-Noord at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Trauma, Compulsive Disorder
- What is being tested?
- EMDR and ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Clients who are crisis-prone or enter in crisis
- Clients who are in forced care (wvggz)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
GGZ NHN
Alkmaar, North Holland, 1817 EX
Elles te Brake, MSc, 0031623942414, e.tebrake@ggz-nhn.nl
Eva Velthorst, PhD, 0031618644345, e.velthorst@ggz-nhn.nl
About this study
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.
Read the detailed description
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.
- Conditions
- Depression, Trauma, Compulsive Disorder, Anxiety, Unexplained Symptom, Medically
- Being tested
- EMDR, ACT
- Keywords
- EMDR intervention, ACT internvention, youth 12.18
- Medical subject headings
- Depression, Wounds and Injuries, Compulsive Personality Disorder, Anxiety Disorders, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDRBehavioural
Eye Movement Desensitization and Reprocessing (EMDR) is a therapy designed to alleviate the distress associated with traumatic memories.
ACTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: EMDR |
| ACT online | Experimental | ACT, along with an e-health program, will be offered through video conferencing. Receives: Behavioral: ACT |
| ACT on-site | Active comparator | ACT will be offered at a physical location without additional e-health modules. Receives: Behavioral: ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: At +/- 1 1/2 month after start treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jul 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GGZ Noord-Holland-Noord
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617663
- Sponsor's protocol ID
- GGZNHNETB2024
- Status last verified
- Aug 2024
- First submitted
- 27 May 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34948601Ravens-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.
PubMed 17668292Porter 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.
PubMed 27837935Stinckens, 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.
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.
PubMed 41327248
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Therapy Youth, Equivalent to Treatment As Usual?
- ClinicalTrials.gov ID
- NCT06617663
- Acronym / sponsor ID
- GGZNHNETB2024
- Conditions
- Depression, Trauma, Compulsive Disorder, Anxiety, Unexplained Symptom, Medically
- Keywords
- EMDR intervention, ACT internvention, youth 12.18
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- GGZ Noord-Holland-NoordUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EMDR online | Experimental | Behavioral: EMDRThe 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 on-site | Active comparator | Behavioral: EMDRThe 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. |
| ACT online | Experimental | Behavioral: ACTACT, along with an e-health program, will be offered through video conferencing. |
| ACT on-site | Active comparator | Behavioral: ACTACT will be offered at a physical location without additional e-health modules. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Clients who are crisis-prone or enter in crisis
- Clients who are in forced care (wvggz)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDREye Movement Desensitization and Reprocessing (EMDR) is a therapy designed to alleviate the distress associated with traumatic memories. | Behavioural | EMDR on-site, EMDR online |
| ACTAcceptance 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. | Behavioural | ACT on-site, ACT online |
Primary outcome
Change in the level of psychological flexibility (for the ACT arms), as measured by the AFQ-Y.
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.
Change in the degree of overall symptomatic distress, as measured by the Youth Outcome questionnaire (YOQ)
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.
Change in post-traumatic symptoms (for the EMDR arms), as measured by the KJTS EMDR questionnaire
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.
Change in the degree of societal recovery, as measured by the kidsscreen-27.
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
1 secondary outcome
Differences in the therapeutic relationship, as measured by the WAV-12 (work alliance questionnaire)
Time frame: At +/- 1 1/2 month after start treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Background: PubMed 34948601Midgley 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.
- Background: PubMed 17668292Ravens-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.
- BackgroundPorter 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
- BackgroundPelzer, A. et al (2022), K. De balans is zoek in Jeugdzorgland. Kind Adolesc Prakt 21, 34-36
- Background: PubMed 27837935Schueller 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.
- BackgroundStinckens, 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.
- BackgroundSchraven, J., et al. (2023) ACT your way, kwaliteit van het protocol en eerste bevindingen van een pilot- effectonderzoek bij adolescenten met een recidiverende depressie
- BackgroundcaleidoZorg & CZ (2023) Tijd effectiviteit van WeMind vs. Lightbar bij EMDR-therapie in een klinische populatie
- BackgroundSwain, J. et al (2015). Acceptance and Commitment Therapy for children: A systematic review of intervention studies.
- Derived from this study: PubMed 41327248Brake 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR and ACT in people with Depression and Trauma, run by GGZ Noord-Holland-Noord at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elles te Brake, Msc (0031623942414, e.tebrake@ggz-nhn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of psychological flexibility (for the ACT arms), as measured by the AFQ-Y. (time frame: At baseline, +/- 3-months after start treatment, and at 6-months after completion of intervention (equals +/- 9 months after baseline assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06617663, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.