First Evaluation of COMET-Y

NCT06343740 | Recruiting

• 1 other identifier: PSY-2324-S-0136
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Self Esteem; Quality of Life

Keywords

Adolescents; Self Esteem; Mental Health Problems; Quality of Life; Ecological Momentary Assesment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Domain-specific Self Esteem

  Two weeks before COMET-Y and a week after COMET-Y

• Mental Health Problems

  Two weeks before COMET-Y and a week after COMET-Y

• Quality of life

  Two weeks before COMET-Y and a week after COMET-Y

• Affect

  Two weeks before COMET-Y and a week after COMET-Y

• Resilience

  Two weeks before COMET-Y and a week after COMET-Y

Study Arms (1)

COMET-Y

EXPERIMENTAL

All participants receive COMET-Y.

Behavioral: COMET-Y

Interventions

COMET-Y BEHAVIORAL

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.

COMET-Y

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Accare: lead

Study Sites (1)

Accare

Groningen, 9723HE, Netherlands

RECRUITING

Central Study Contacts

Rianne Hornstra, PhD.

CONTACT

(050) 368 11 00; r.hornstra@accare.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study is a pre-post study.

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 3, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data can be requested after publication.
• 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.

Locations

NL (1)