AzTrials
AzTrials

Anxiety DisordersNCT04716777

Brief Transdiagnostic Group CBT for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial

A study testing Brief Transdiagnostic group-based Cognitive-Behavioral Treatment in people with Anxiety Disorders and Depressive Disorder, run by University of Iceland at 1 site in Iceland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The investigators will evaluate a brief group-based cognitive-behavioral treatment program for adolescents aged 13-17 years with internalizing problems. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Anxiety Disorders, Depressive Disorder, Anxiety
What is being tested?
Brief Transdiagnostic group-based Cognitive-Behavioral Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIceland
Study dates
15 Oct 2020to 20 Sep 2023
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 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 1 SD above normal population mean on the Revised Children's Anxiety and Depression Scale (parent- or self-report), subscale or total score OR a K-SADS-PL confirmed anxiety or depressive disorder.

Who cannot join

  • Inadequate language proficiency by the patient or the parent.
  • The presence of other psychiatric disorders having a higher treatment priority (i.e., psychosis and acute sucide risk)
  • Intellectual Disability

Trial locations and contacts

1 site in 1 country.

Gudmundur Skarphedinsson, PhD contact

003545525573

gskarp@hi.is

Iceland1 site, 1 recruiting
  • Primary Health Care Clinic

    Reykjavik, 112

    Gunnar Karlsson, MSc, 003545135200, gkk@simnet.is

    Gunnar Karlsson, MSc

    Recruiting

Other trials in Iceland

About this study

Official title: Brief Transdiagnostic Group Cognitive-Behavioral Treatment for Adolescents With Internalizing Problems: A Randomized Waitlist Controlled Trial

The investigators will evaluate a brief group-based cognitive-behavioral treatment program for adolescents aged 13-17 years with internalizing problems.

Read the detailed description

Internalizing disorders (anxiety and depression) are among the most prevalent psychiatric disorders in youth. Cognitive-behavioral treatment (CBT) is well-establed treatment for internalizing disorders. The evidence originates mostly from disorder-specific CBT for youth. However, the validity of specific diagnosis has been questioned, especially because of high symptom overlap between disorders and the high rates of diagnostic comorbidity. In addition, research has suggested that depressive comorbidity is associated with reduced treatment effectiveness for primary anxiety disorder and vice versa. A recent meta-analysis, of the collective evidence of psychotherapy throught 50 years, revealed that there were no effects of disorder-specific psychotherapy for youths with one or more comorbid disorder. Which indicates that disorder-specific treatment is not sufficient for children with comorbidity.

Transdiagnostic treatments have been developed and evaluated to address this problem. These treatments emphasize effective therapeutic principles which may be applied across multiple disorders. Transidagnostic treatment may be more cost effective and practical than disorder-specific treatments as most therapists only need to be trained extensively in one protocol. Transdiagnostic treatments may also be easily learned by clinicians and especially in generalist settings where one transdiagnostic protocol can be offered to patients with various mental health problems instead of many offered to much fewer. Offering transdiagnostic treatment approach may better serve the diagnostically heterogeneous groups which seek help at general clinics instead of many different disorder-specific treatment protocols. Transdiagnostic CBT protocols have been proved to be effective among adults with internalizing disorders and also among youths. It has also been showed that transdiagnostic CBT was equally effective as anxiety disorder-specific protocol for adults with anxiety disorders.

Treatment Our treatment is a brief group-based cognitive-behavioral treatment which was specifically designed for adolescents with impairing internalizing symptoms, or anxiety/depressive disorders seeking help at the Primary Health Care Clinics in Iceland. The treatment comprises eight weekly 110-minutes sessions were the following components are applied: (1) psychoeducation, (2) cognitive restructuring, (3), behavioral activation, (4) exposure, (5) problem solving, (6) social skills, and (7) mindfulness. The participants receive a workbook with outline of each sessions and assignments related to components (e.g., (e.g., ABC workseets, exposure exercises). They are encouraged to practice skills learned in sessions between sessions. All parents attend two sessions. They receive detailed psychoeducation and are instructed in assisting their children with the homework assignments (week 1), and in week 6 they are instructed how to assist their children with exposure exercises. They also receive a workbook with outline of each sessions. The therapist also has at least one telephone call with each family to follow-up on exercises.

Study design and participants The following study is a randomized controlled trial where participants are allocated to either eight weekly sessions of brief transidagnostic CBT or waitlist monitoring for clinical deterioration. The investigators will randomize by using blockwise procedure determined by a computer-generated algorithm. To ensure that the randomization will not be predicted in advance, it will be centralized at the University of Iceland. Participants will be assigned to study group after being deemed eligible and undergoing consent.

Assessment Participants will be assessed at baseline, midtreatment, posttreatment (week 8), 2 months follow-up, 4 months follow-up, and 1-year follow-up.

Being tested
Brief Transdiagnostic group-based Cognitive-Behavioral Treatment
Keywords
Transdiagnostic Cognitive-Behavioral Treatment, Cognitive-Behavioral Treatment, Group Treatment, Randomized Controlled Trial
Medical subject headings
Anxiety Disorders, Depressive Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Transdiagnostic group-based Cognitive-Behavioral TreatmentBehavioural

    Weekly group-based transdiagnostic CBT sessions for eight weeks.

Study groups in NCT04716777
Study groupRoleWhat they receive
Brief Transdiagnostic GCBTExperimentalParticipants receive Brief Transdiagnostic group cognitive-behavioral treatment. Eight weekly sessions.
Receives: Behavioral: Brief Transdiagnostic group-based Cognitive-Behavioral Treatment
WaitlistNo interventionParticipants receive an 8-week waitlist condition with some attentional-control via monitoring for clinical deterioration. After a post-waitlist assessment, participants in this condition are offered the Brief Transiagnostic GCBT for eight weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Revised Children's Anxiety and Depression Scale (RCADS)

    Self-report total score of anxiety / depression

    Measured: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)

Secondary outcomes (3)
  1. Parent-report of the Revised Children's Anxiety and Depression Scale (RCADS)

    Parent-report total score of anxiety / depression

    Measured: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)

  2. KINDL Quality of life, parent- and self-report

    generic instrument for assessing Health-Related Quality of Life in children and adolescents

    Measured: Measured at baseline and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)

  3. Clinical reliable change and clinical significant change

    Based on the RCADS self-report using the approach by Jacobson and Truax

    Measured: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start15 Oct 2020
  3. Primary completion20 Jan 2023 (estimated)
  4. Study completion20 Sep 2023 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to one of two conditions 8-week treatment or 8-week waitlist.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716777
Sponsor's protocol ID
VSN-20-115
Status last verified
Mar 2022
First submitted
19 Jan 2021
Last updated
14 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Brief Transdiagnostic group-based Cognitive-Behavioral Treatment in people with Anxiety Disorders and Depressive Disorder, run by University of Iceland at 1 site in Iceland.

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 1 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iceland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gudmundur Skarphedinsson, PhD (003545525573, gskarp@hi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Revised Children's Anxiety and Depression Scale (RCADS) (time frame: Measured at baseline, week 4, and week 8 (post-treatment). Measured at 2-, 4-months, and 1-year follow-up (open trial)). 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 14 Nov 2022.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in