angststoornissen anxiety Depression mood disorder
Conditions
Interventions
ERT consists of 6 online sessions of 25 minutes. These will be combined with 2
face-to-face sessions, resulting in a so-called blended treatment. The study
will make use of the online Therapieland p
hence, ERT will be completed in 6 to 12 weeks. The content
of the program is based on existing face-to-face ER interventions for children
and adolescents (Southam-Gerow, 2014). The intervention comp
Sponsors
Arkin (Amsterdam)
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1) Primary diagnosis of depressive disorder or anxiety disorder according to DSM-5 criteria 2) Indication for CBT at Arkin Jeugd&Gezin 3) Age 13-18 years 4) Regular access to a computer, tablet or mobile phone with internet connection 5) Informed consent regarding study participation provided by the participant, and in case patient is
Exclusion criteria
Exclusion criteria: 1) Psychotic disorder according to DSM-5 criteria 2) Acute suicidal behavior 3) Insufficient understanding of the spoken and written Dutch language 4) Substance dependency that requires treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability and feasibility of add-on ERT training and trial design Quantitative data: - Patient satisfaction with ERT training (modified version of the Client Satisfaction Questionnaire; CSQ-8) (T2) - Intervention uptake of both CBT and ERT, based on electronic patient record registrations and online intervention data. We will register the compliance (i.e., amount of completed sessions) for both CBT and ERT, as well as the amount of no shows (for CBT), and the reasons for termination of treatment (for CBT and ERT). - Recruitment and refusal rates, retention rates, follow-up rates of all outcome measures of both patients and their parents. - Therapist satisfaction with internet module (System Usability Scale) Qualitative data: - Qualitative evaluation of ERT training by respondents in focus groups - Adolescent patients preferences regarding add-on e-health interventions - Evaluation of feasibility for therapists to guide participants through the add-on ERT training in focus groups We will conduct a focus group with a random sample of 12 participants of the experimental condition to examine the acceptability of the internet-based ER training. Qualitative research methods aimed at analyzing focus groups will be used; audio tapes will be separately analyzed by two researchers. To motivate participants for these focusgroups every participant will receive a reward of ¤25,- (bol.com voucher). A similar focusgroup will be organized will all therapists that used the ERT-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients - Depressive symptoms Depressive symptoms will be measured with the Dutch version of the Children*s Depression Inventory, second edition (Bodden, Braet, & Stikkelbroek, 2016). A CDI-2 cut-off score of 16 is indicative of *significant* depressive symptoms according to the Dutch Mental Health Care guideline (Buitelaar et al., 2009: Multidisciplinaire Richtlijn GGZ, Addendum Depressie bij Jeugd, 2009). Patients will fill in this questionnaire at T0, T1, and T2. The primary endpoint for patients with a primary depressive disorder is the level of depressive symptoms (continuous variable) at T2. The continuous primary outcome measures are depressive symptoms (as measured with the CDI-2) and anxiety symptoms (as measured with the SCARED) at T2. - Anxiety symptoms Anxiety symptoms will be measured with the Screen for Child Anxiety Related Emotional Disorders (SCARED; Muris, Bodden, Hale, Birmaher, & Mayer, 2007). With the SCARED it is possible to assess different anxiety disorders, according to the DSM-IV (Hale et al., 2009). The questionnaire distinguishes between panic disorder, separation anxiety, specific phobia (animal type, medical type, and situational type), social phobia, obsessive-compulsive disorder, posttraumatic stress disorder, and general anxiety. The total score of the SCARED ranges between 0 and 207. Both the child and parent version have been demonstrated to have good psychometric properties and clinical relevance (Runyon et al., 2018). Patients will fill in this questionnaire at T0, T1, and T2. The primary endpoint for patients with a primary anxiety disorder is the level of anxiety symptoms (continuous variable) at T2. - Emotion Regulation (Feel KJ) (T0, T1, T2) - Behavioural competency and problems (Youth Self-report Scale, Child version)* (T0, T2) *To reduce workload for participants, only the subscale "Internalizing problems" will be used. Parent/caregivers - Behavioural competency and problems (Child Behaviour | — |
Countries
Netherlands
Outcome results
None listed