Anxiety DepressionNCT05827809
Feasibility, Acceptability and Effect of a Transdiagnostic Psychological Treatment for Anxiety and Depression in Youth.
A study testing Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depression in people with Anxiety Depression and CBT, run by Lena Reuterskiold at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Anxiety Depression, CBT
- What is being tested?
- Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- 8 Aug 2022to 30 Oct 2024
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Psychosis, bipolar disorder. substance use syndrome, severely suicidal or pervasive developmental disorder
- Ongoing other psychological treatment
- Abuse or domestic violence
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Liljeholmens Vårdcentral
Stockholm, 11794
Älvsjö Vårdcental
Stockholm, Älvsjö, 12531
About this study
Official title: A Transdiagnostic Psychological Treatment for Anxiety and Depression in Youth: Feasibility, Acceptability and Effect in a Clinical Open Trial in Primary Care
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:
Read more
- What are the children's (patients) and parents experience of undergoing a transdiagnostic psychological treatment (UP-C/A) in primary care?
- What are the therapists' experience of having carried out the treatment with a transdiagnostic psychological treatment (UP-C/A) in primary care?
- To what extent do children and parents answer self-reports and clinician administered instruments regarding symptoms of anxiety, depression, function and quality of life?
- To what extent do children and their parents complete the treatment and what is the dropout rate?
- What does the distribution of diagnoses and co-morbidity look like for patients included in the study?
- 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.
- 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).
Read the 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.
- Conditions
- Anxiety Depression, CBT
- Being tested
- Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depression
- Keywords
- Unified Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depressionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
A self-report and parent report that measures symptoms of anxiety and depression. Minimum value 0 and maximum 141, where higher scores indicate more anxiety and depression symptoms.
Measured: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
The Strengths and difficulties questionnaire (SDQ)
A self-report for children from 11 years of age and their parents that assessing mental health, behavior and peer problems in children 7-17 years. Minimum value 0, maximum 40. Higher scores indicate more problems, apart from the prosocial subscale where higher scores indicate more prosocial behavior.
Measured: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
Kidscreen-10 Index
A brief self-report, with 10 items, for children and their parents intended to measure health-related quality of life. Scores range from 1 to 5. Higher scores generally indicate a better quality of life, some scores have to be reversed.
Measured: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
Children's Global Assessment Scale (C-GAS).
Assessment of the child´s functional level by the clinician. Scores range from 0-100, with higher scores indicating a higher functioning.
Measured: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
Client Satisfaction Questionnaire (CSQ-8)
A child and parent self-report on general treatment satisfaction. Scores range from 8-32, with higher scores indicating more satisfaction.
Measured: After treatment completion at 12 weeks.
A scale on the Acceptability of Intervention Measure (AIM); Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM).
Clinician report. Three subscales, with scores ranging from a minimum of 12 and a maximum of 60. Higher scores indicating a better fit with implementation in clinic.
Measured: After the treatment group intervention is completed at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start8 Aug 2022
- Primary completion28 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety 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
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lena Reuterskiold
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Lena Reuterskiold, Region Stockholm
- Investigators
- Lena Reuterskiöld, PhD, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827809
- Sponsor's protocol ID
- 2021-05939-01
- Status last verified
- Feb 2025
- First submitted
- 27 Mar 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Transdiagnostic Psychological Treatment for Anxiety and Depression in Youth: Feasibility, Acceptability and Effect in a Clinical Open Trial in Primary Care
- ClinicalTrials.gov ID
- NCT05827809
- Acronym / sponsor ID
- 2021-05939-01
- Conditions
- Anxiety Depression, CBT
- Keywords
- Unified Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lena ReuterskioldOther government
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 25 Apr 2023 (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.
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:
- What are the children's (patients) and parents experience of undergoing a transdiagnostic psychological treatment (UP-C/A) in primary care?
- What are the therapists' experience of having carried out the treatment with a transdiagnostic psychological treatment (UP-C/A) in primary care?
- To what extent do children and parents answer self-reports and clinician administered instruments regarding symptoms of anxiety, depression, function and quality of life?
- To what extent do children and their parents complete the treatment and what is the dropout rate?
- What does the distribution of diagnoses and co-morbidity look like for patients included in the study?
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol (UP-C/A) for children and youth with anxiety disorders and/or depression | Experimental | Behavioral: Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depressionA 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Psychosis, bipolar disorder. substance use syndrome, severely suicidal or pervasive developmental disorder
- Ongoing other psychological treatment
- Abuse or domestic violence
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 |
|---|---|---|
| Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depressionA 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. | Behavioural | Unified Protocol (UP-C/A) for children and youth with anxiety disorders and/or depression |
Primary outcome
Emotion Regulation Index for Children and Adolescents (ERICA)
Time frame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
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.
6 secondary outcomes
Revised Children's Anxiety and Depression Scale (R-CADS)
Time frame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
The Strengths and difficulties questionnaire (SDQ)
Time frame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
Kidscreen-10 Index
Time frame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
Children's Global Assessment Scale (C-GAS).
Time frame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: After treatment completion at 12 weeks.
A scale on the Acceptability of Intervention Measure (AIM); Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM).
Time frame: After the treatment group intervention is completed at 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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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.
Lena Reuterskiöld, PhD principal investigator
Region Stockholm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol (UP-C/A) for children and youth with anxiety disorders and /or depression in people with Anxiety Depression and CBT, run by Lena Reuterskiold at 2 sites in Sweden.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Index for Children and Adolescents (ERICA) (time frame: Change from pre intervention to treatment completion at 12 weeks and at a 6 month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.