Self EsteemCOMET-YNCT06343740
First Evaluation of COMET-Y
A study testing COMET-Y in people with Self Esteem and Quality of Life, run by Accare at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Self Esteem, Quality of Life
- What is being tested?
- COMET-Y
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2024to Apr 2026
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Self Esteem, Quality of Life
- Being tested
- COMET-Y
- Keywords
- Adolescents, Self Esteem, Mental Health Problems, Quality of Life, Ecological Momentary Assesment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMET-YBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COMET-Y | Experimental | All participants receive COMET-Y. Receives: Behavioral: COMET-Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Esteem
Global self esteem measured with the Rosenberg self-esteem scale (RSES). Range: 0-30, higher score means higher self-esteem.
Measured: Two weeks before COMET-Y and a week after COMET-Y
Secondary outcomes (8)
Domain-specific Self Esteem
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.
Measured: Two weeks before COMET-Y and a week after COMET-Y
Mental Health Problems
Mental health problems measured with the Strengths and Difficulties Questionnaire (SDQ). Range total score: 0-40, with a higher score corresponding to more problems.
Measured: Two weeks before COMET-Y and a week after COMET-Y
Quality of life
Several aspects of quality of life measured with the Kidscreen-27. Range: 0-130, a higher score means a higher quality of life.
Measured: Two weeks before COMET-Y and a week after COMET-Y
Affect
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).
Measured: Two weeks before COMET-Y and a week after COMET-Y
Resilience
Resilience is measured with the Brief Resilience Scale (BRS). Range: 1-5, a higher score indicates more resilience.
Measured: Two weeks before COMET-Y and a week after COMET-Y
Ecological Momentary Assessments - Global self-esteem
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.
Measured: Two weeks before and two weeks after COMET-Y
Ecological Momentary Assesments - Goal Based Outcome (GBO) tool for young people
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.
Measured: Two weeks before and two weeks after COMET-Y
Ecological Momentary Assesments - Domain-specific self-esteem
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.
Measured: Two weeks before and two weeks after COMET-Y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EsteemStudies 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
- This pilot study is a pre-post study.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343740
- Sponsor's protocol ID
- PSY-2324-S-0136
- Acronym
- COMET-Y
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will ask permission to share the pseudonymized data for potential future re-analysis, such as in a individual participant meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: A First Evaluation of a Personalized Training Targeting Low Self-esteem: COMET-Y
- ClinicalTrials.gov ID
- NCT06343740
- Acronym / sponsor ID
- COMET-Y / PSY-2324-S-0136
- Conditions
- Self Esteem, Quality of Life
- Keywords
- Adolescents, Self Esteem, Mental Health Problems, Quality of Life, Ecological Momentary Assesment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- AccareUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 3 Apr 2024 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot study is a pre-post study.
| Arm | Type | Receives |
|---|---|---|
| COMET-Y | Experimental | Behavioral: COMET-YAll participants receive COMET-Y. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| COMET-YCompetitive 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. | Behavioural | COMET-Y |
Primary outcome
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.
8 secondary outcomes
Domain-specific Self Esteem
Time frame: 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
Quality of life
Time frame: 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
Resilience
Time frame: 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
Ecological Momentary Assesments - Goal Based Outcome (GBO) tool for young people
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. We will ask permission to share the pseudonymized data for potential future re-analysis, such as in a individual participant meta-analysis.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMET-Y in people with Self Esteem and Quality of Life, run by Accare at 1 site in Netherlands.
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 1 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 15 Aug 2024. 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 Netherlands. 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 Rianne Hornstra, PhD. ((050) 368 11 00, r.hornstra@accare.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Esteem (time frame: Two weeks before COMET-Y and a week after COMET-Y). 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 15 Aug 2024.