First Evaluation of COMET-Y

Quality of Life Clinical Trial

— COMET-Y  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06343740
• Other study ID #: PSY-2324-S-0136
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Accare
• Contact: Rianne Hornstra, PhD.
• Phone: (050) 368 11 00
• Email: r.hornstra[@]accare.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Quality of Life
• Self Esteem

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Accare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self Esteem	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	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.	Two weeks before COMET-Y and a week after COMET-Y
Secondary	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.	Two weeks before COMET-Y and a week after COMET-Y
Secondary	Quality of life	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
Secondary	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).	Two weeks before COMET-Y and a week after COMET-Y
Secondary	Resilience	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
Secondary	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.	Two weeks before and two weeks after COMET-Y
Secondary	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.	Two weeks before and two weeks after COMET-Y
Secondary	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.	Two weeks before and two weeks after COMET-Y