Clinical trial NCT05827809: Feasibility, Acceptability and Effect of a Transdiagnostic Psychological Treatment for Anxiety and Depression in Youth.
Official title: A Transdiagnostic Psychological Treatment for Anxiety and Depression in Youth: Feasibility, Acceptability and Effect in a Clinical Open Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
CBT
Keywords: Unified Protocol
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A clinical open trial evaluating feasibility, acceptability, treatment facilitators as well as treatment effects measured before, after and at 6-month follow-up, for a relatively new transdiagnostic psychological treatment, Unified Protocol, for children and youth with anxiety disorders and/or depression and their parents.

The therapists in the project will also be in-depth interviewed about the treatment feasibility, compliance and acceptance of the treatment intervention. The study is conducted at 2 primary care clinics with patients and parents seeking for routine care.
Primary purpose: TREATMENT

Brief summary: The goal of this open clinical trial is to try out and evaluate a relatively new transdiagnostic psychological treatment, Unified Protocol (UP-C/A), in group format for children and adolescents aged 7-17 years of age with anxiety and/or depression and their parents, in primary care. The therapists in the project will receive training and on-going supervision in UP-C/A.

The main questions it aims to answer are:

1. What are the children's (patients) and parents experience of undergoing a transdiagnostic psychological treatment (UP-C/A) in primary care?
2. What are the therapists' experience of having carried out the treatment with a transdiagnostic psychological treatment (UP-C/A) in primary care?
3. To what extent do children and parents answer self-reports and clinician administered instruments regarding symptoms of anxiety, depression, function and quality of life?
4. To what extent do children and their parents complete the treatment and what is the dropout rate?
5. What does the distribution of diagnoses and co-morbidity look like for patients included in the study?
6. What is the treatment outcome with regard to emotion regulation, symptoms of anxiety, depression, function and quality of life? rated by patients, parents and therapists.
7. To what extent are any effects maintained at a 6-month follow-up?

The participants and their parents will partake in group treatment with Unified Protocol of 11 sessions following an initial screening with the Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID).

Detailed description: Participants in the study are children (7 to 17 years of age) seeking help for anxiety and depression in routine primary care and their parents. The children are screened with the Mini-International Neuropsychiatric Interview for children and adolescents (MINI-KID). Patients assessed as fulfilling criteria for anxiety disorders, obsessive compulsive disorders and/or depression and checked against inclusion and exclusion criteria are informed about the project orally and in writing. Informed consent is obtained verbally and in writing. Recruitment in the two separate clinical sites continues until up to 8 children and their parents constitute a group.

After inclusion children and their parents fill in self-report scales. Some of these self-report scales are already in use in the primary care platform (SDQ) and (R-CADS). The ERICA, KIDSCREEN-10, Client Safisfaction Questionnaire (CSQ) are in paperformat and saved in the clinic. The therapist in the project are asked to fill in a scale that assesses feasibility and acceptability of the intervention, after treatment completion.

Data will be analysed descriptively to answer research question from self-reports from the children, parents and therapist as to satisfaction with treatment, feasibility and acceptability. Treatment effect will be analyzed with paired sample t-test on primary and secondary outcomes.

Therapist have received training in UP-C/A by certified educators in UP and will receive on-going supervision in Unified-Protocol by a UP-certified psychologist, during the group intervention. Also, the group intervention is audio-taped. A random sample of 20% of the sessions will be rated as to compliance with the Unified Protocol. The ratings will be performed by the project investigator, also trained in UP-C/A.

A sample size of about 30 is aimed for based on an average of 6 patients in a group and five treatment groups in total. One clinic is aiming for three groups and the other for two treatment groups. Detailed and clear information about the treatment, time consumption for child and parent groups and a good structure for data collection in the clinics are some planned strategies to minimize dropouts and data loss.

From the overall collected data on child and parent satisfaction, therapist ratings of acceptability, feasibility and treatment effects at a 6-month follow-up, a randomized controlled trial (RCT) is planned for in primary care.

Eligibility criteria: Inclusion Criteria:

* Age 7-17 years of age
* Anxiety syndrome, obsessive-compulsive disorder and/or depression according to the Diagnostic and Statistical Manual of Mental disorders (DSM) as primary problem
* Patients and parents master the Swedish language without interpreter support.
* Willingness/ability to participate after receiving information about what participation entails
* In case of medication, this is on a stable dose, since six weeks

Exclusion Criteria:

* Psychosis, bipolar disorder. substance use syndrome, severely suicidal or pervasive developmental disorder
* Ongoing other psychological treatment
* Abuse or domestic violence

Primary outcomes:
measure: Emotion Regulation Index for Children and Adolescents (ERICA)
timeFrame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
Secondary outcomes:
measure: Revised Children's Anxiety and Depression Scale (R-CADS)
timeFrame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
measure: The Strengths and difficulties questionnaire (SDQ)
timeFrame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
measure: Kidscreen-10 Index
timeFrame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
measure: Children's Global Assessment Scale (C-GAS).
timeFrame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: After treatment completion at 12 weeks.
measure: A scale on the Acceptability of Intervention Measure (AIM); Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM).
timeFrame: After the treatment group intervention is completed at 12 weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Liljeholmens Vårdcentral
city: Stockholm
country: Sweden
facility: Älvsjö Vårdcental
state: Älvsjö
Study officials:
affiliation: Region Stockholm
name: Lena Reuterskiöld, PhD
role: PRINCIPAL_INVESTIGATOR
References: