First Evaluation of COMET-Y (COMET-Y)

August 14, 2024 updated by: Accare

A Pilot Study: A First Evaluation of a Personalized Training Targeting Low Self-esteem: COMET-Y

The goal of this pilot study is to evaluate COMET-Y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. The main questions is: Does COMET-Y, parallel to care as usual (CAU), improve self-esteem?

Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Youth and therapists will be assessed to evaluate feasibility and acceptability of the COMET-Y training.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Low self-esteem plays an important role in various mental health problems, and targeted treatment of self-esteem could potentially enhance the efficacy of existing treatments. Research in adults shows that self-esteem training improves self-esteem and mental health problems, but in adolescents this is still unknown. COMET-Y is a personalized self-esteem training, specifically developed for adolescents.

In this pilot study, 22 adolescents (11-18 years) with various mental health problems and low self-esteem will be included. Participants receive COMET-Y parallel to care as usual (CAU). Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Feasibility and acceptability of the COMET-Y training will be evaluated with youth and therapists.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9723HE
        • Recruiting
        • Accare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • sufficient mastery of Dutch to complete the measurements
  • age between 11 - 18 years
  • having self-esteem below average (based on a score =<15 on the Rosenberg Self-esteem Scale; RSES)
  • currently receiving care for a mental disorder, for example (but not limited to) anxiety disorder, depression, eating disorder, attention-deficit/hyperactivity disorder, oppositional defiant disorder, or autism spectrum disorder.
  • willingness to participate in weekly sessions

Exclusion Criteria:

• As intensive treatment can restrain the feasibility of attending the 7 weekly sessions of COMET-Y and engage in homework assignments, participants who need acute care are excluded (e.g. crisis, acute suicidality, or psychotic episode).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COMET-Y
All participants receive COMET-Y.
Behavioral: COMET-Y
Competitive memory training (COMET) is a transdiagnostic intervention first developed for adults and later adapted to be used in children and adolescents. The adapted version for youth consists of 7 sessions in which participants learn to facilitate activation of functional/positive thoughts instead of relying on dysfunctional/negative thoughts by using positive self-verbalizations, imagery, body posture, and music. In addition, they are challenged to reformulate dysfunctional/negative thoughts into more functional/positive thoughts. As an addition to the original COMET protocol, there is a parent session in which parents receive psycho-education about their influence on self-esteem. Parents learn to be a 'co-therapist' and to support practicing at home and improve generalization.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self Esteem
Time Frame: Two weeks before COMET-Y and a week after COMET-Y
Global self esteem measured with the Rosenberg self-esteem scale (RSES). Range: 0-30, higher score means higher self-esteem.
Two weeks before COMET-Y and a week after COMET-Y

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Domain-specific Self Esteem
Time Frame: Two weeks before COMET-Y and a week after COMET-Y
Domain-specific self esteem measured with the Competentiebelevingsschaal voor adolescenten (CBSA). Range: 5-20 for each subscale, a higher score means more competence for the specific domains.
Two weeks before COMET-Y and a week after COMET-Y
Mental Health Problems
Time Frame: Two weeks before COMET-Y and a week after COMET-Y
Mental health problems measured with the Strengths and Difficulties Questionnaire (SDQ). Range total score: 0-40, with a higher score corresponding to more problems.
Two weeks before COMET-Y and a week after COMET-Y
Affect
Time Frame: Two weeks before COMET-Y and a week after COMET-Y
Positive and negative affect, measured with the Positive and negative affects schedule. (PANAS-C). Range: 0-100, with a higher score higher affect (positive or negative).
Two weeks before COMET-Y and a week after COMET-Y
Resilience
Time Frame: Two weeks before COMET-Y and a week after COMET-Y
Resilience is measured with the Brief Resilience Scale (BRS). Range: 1-5, a higher score indicates more resilience.
Two weeks before COMET-Y and a week after COMET-Y
Ecological Momentary Assessments - Global self-esteem
Time Frame: Two weeks before and two weeks after COMET-Y

Global self-esteem: short-version of the Rosenberg Self-esteem Scale, as part of a short questionnaire filled in three times a day by the participants via their mobile phones.

Range: 0-16, higher score means higher self-esteem.
Two weeks before and two weeks after COMET-Y
Ecological Momentary Assesments - Goal Based Outcome (GBO) tool for young people
Time Frame: Two weeks before and two weeks after COMET-Y

The Goal-Based Outcome (GBO) tool for young people, as part of a short questionnaire filled in three times a day by the participants via their mobile phones.

Participants fill in three personalized goals, which they rate on a scale from 1-10, where higher scores indicate improved goal progress.
Two weeks before and two weeks after COMET-Y
Ecological Momentary Assesments - Domain-specific self-esteem
Time Frame: Two weeks before and two weeks after COMET-Y
Domain-specific self-esteem: perceived self-esteem related functioning covering the specific domains measured by the Competentiebelevingsschaal voor Adolescenten. Range: 0-60, where higher scores indicate more competence.
Two weeks before and two weeks after COMET-Y
Quality of life
Time Frame: Two weeks before COMET-Y and a week after COMET-Y
Several aspects of quality of life measured with the Kidscreen-27. Range: 0-130, a higher score means a higher quality of life.
Two weeks before COMET-Y and a week after COMET-Y

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Accare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSY-2324-S-0136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will ask permission to share the pseudonymized data for potential future re-analysis, such as in a individual participant meta-analysis.

IPD Sharing Time Frame

Data can be requested after publication.

IPD Sharing Access Criteria

A pseudonymised dataset and analysed dataset will be archived so that data can be shared or checked later (FAIR data use) if the participants have agreed to that.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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