No registrations found.
ID
Source
Brief title
Health condition
Depression
Anxiety
Emotion regulation
Psychiatric disorders
Sponsors and support
Intervention
Outcome measures
Primary outcome
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, 6 months after baseline)
- 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
Secondary outcome
Patients
Depressive symptoms
- Dutch version of the Children’s Depression Inventory, second edition. The primary endpoint for patients with a primary depressive disorder is the level of depressive symptoms (continuous variable) at T2 (6 months after baseline).
Anxiety symptoms
- Screen for Child Anxiety Related Emotional Disorders. 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 Checklist List, Parent version) (T0, T2)
- Depressive symptoms of patient (CDI-2 parent version) (T0, T1, T2)
- Anxiety symptoms of patient (SCARED parent version) (T0, T1, T2)
Therapists
- Clinician's view of the patient's global functioning and improvement (Clinical Global Impressions scale; CGI) (T0, T1, T2)
Background summary
Depressive and anxiety disorders are highly prevalent among adolescents. Research suggests emotion dysregulation to play an important role in this critical developmental phase. Given the important role of emotion regulation in the development and duration of depressive and anxiety disorders, we hypothesize that enhancing regular treatment for these disorders with an internet-based emotion regulation training may reduce depressive and anxiety symptoms.
The primary aim of the proposed study is to examine the acceptability and feasibility of an add-on internet-based emotion regulation training investigated in a randomized controlled trial (RCT) in adolescents with depressive and anxiety disorders and their therapists. Second, this study aims to provide a first estimate of the effectiveness of CBT + ERT in reducing depressive and anxiety symptoms against CBT alone in adolescent patients (aged 13-18) with depressive or anxiety disorders, in preparation of a future, larger RCT.
Study objective
Anxiety and depressive disorders are common in children and adolescents. Given the high prevalence and detrimental effects of anxiety and depressive disorders in adolescents, it is of utmost importance to gain insight into potential mechanisms underlying these disorders in this vulnerable group. Research suggests emotion dysregulation to play an important role in this critical developmental phase. Given the important role of emotion regulation in the development and duration of depressive and anxiety disorders, we hypothesize that enhancing regular treatment for these disorders with an internet-based emotion regulation training may reduce depressive and anxiety symptoms.
The primary aim of the proposed study is to examine the acceptability and feasibility of an add-on internet-based emotion regulation training investigated in a randomized controlled trial (RCT) in adolescents with depressive and anxiety disorders and their therapists. Second, this study aims to provide a first estimate of the potential effectiveness of CBT + ERT in reducing emotion regulation difficulties, depressive symptoms, and anxiety symptoms against CBT alone in adolescent patients (aged 13-18) with depressive or anxiety disorders, in preparation of a future, definitive RCT.
Study design
T0: Baseline (0 months)
T1: 3 months after baseline
T2: 6 months after baseline
Intervention
Intervention: An internet-based Emotion Regulation Training that consists of 6 sessions, with guidance by a trained ER therapist will be added to treatment as usual (cognitive behavioural therapy).
Control intervention: regular Cognitive Behavioral Therapy.
Inclusion criteria
(1) Primary diagnosis of depressive disorder or anxiety disorder;
(2) Enrolling for cognitive behavioural therapy at Arkin Jeugd & Gezin in Amsterdam;
(3) Age 13-18 years;
(4) At least moderately proficient in Dutch;
(5) Regular access to a computer, tablet or mobile phone with internet connection;
(6) Informed consent regarding study participation provided by the participant, and in case the patient is <16 years, both parents.
Exclusion criteria
(1) Current psychotic disorder;
(2) Acute suicidal behavior;
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8304 |
| CCMO | NL69405.100.19 |
| OMON | NL-OMON48366 |