Feasibility, Acceptability and Effect of a Transdiagnostic Psychological Treatment for Anxiety and Depression in Youth.

NCT05827809 | Completed

• 1 other identifier: 2021-05939-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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. 1.What are the children's (patients) and parents experience of undergoing a transdiagnostic psychological treatment (UP-C/A) in primary care?
2. 2.What are the therapists' experience of having carried out the treatment with a transdiagnostic psychological treatment (UP-C/A) in primary care?
3. 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. 4.To what extent do children and their parents complete the treatment and what is the dropout rate?
5. 5.What does the distribution of diagnoses and co-morbidity look like for patients included in the study?
6. 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. 7.To what extent are any effects maintained at a 6-month follow-up?

Conditions

Anxiety Depression; CBT

Keywords

Unified Protocol

Outcome Measures

Primary Outcomes (1)

• Emotion Regulation Index for Children and Adolescents (ERICA)

  A self-report that measures various aspects of emotion regulation with three subscales: 1: Emotional Control (lower scores indicate more emotional control); 2: Emotional Self-Awareness (higher scores indicate more emotional self-awareness); 3: Situational Responsiveness (higher scores indicate more situational responsiveness). 16 items in total. Some scores are reversed. Likert-type scale 1 to 5.

  Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.

Secondary Outcomes (6)

• Revised Children's Anxiety and Depression Scale (R-CADS)

  Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.

• The Strengths and difficulties questionnaire (SDQ)

  Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.

• Kidscreen-10 Index

  Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.

• Children's Global Assessment Scale (C-GAS).

  Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.

• Client Satisfaction Questionnaire (CSQ-8)

  After treatment completion at 12 weeks.

Study Arms (1)

Unified Protocol (UP-C/A) for children and youth with anxiety disorders and/or depression

EXPERIMENTAL

A within group design where one clinical manualised intervention, the Unified protocol based on the third-wave of Cognitive Behavior Therapy (CBT), is offered in a 11 session group format to children and adolescents. Parent training is at the same time also offered in a group format. Therapists are trained in the method and receive regular supervision adhering to the evidence-based manual. The group treatment and parent training is delivered face-to- face.

Behavioral: Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depression

Interventions

Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depression BEHAVIORAL

A transdiagnostic psychological group treatment, Unified Protocol (UP-C/A), one intervention, is tested for children and youth with anxiety disorders and/or depression seeking help in routine care in two primary care locations. Parents are at the same time offered parent training in a group format coupled with the module the children are working on. Feasibility, acceptability and effect of the intervention will be studied, with child self-report, parent-report and therapist assessment.

Unified Protocol (UP-C/A) for children and youth with anxiety disorders and/or depression

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lena Reuterskiold: lead

Study Sites (2)

Liljeholmens Vårdcentral

Stockholm, 11794, Sweden

Location

Älvsjö Vårdcental

Stockholm, Älvsjö, 12531, Sweden

Location

Study Officials

• Lena Reuterskiöld, PhD

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 25, 2023
• Study Start: August 8, 2022
• Primary Completion: August 28, 2024
• Study Completion: October 30, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

SE (2)