NCT07633899

Brief Summary

This study involves two groups of participants: one participating in an intervention focused on self-esteem-and thus primarily psychological-and the other on self-esteem and tennis-and thus involving physical activity. The objectives of this study are to document participants' experiences following their participation in the group offered to them, as well as to quantify any changes in the various areas detailed below. In this study, we aim to identify the benefits gained following a group intervention in the social, academic/professional, clinical, and physical domains; we also seek to objectively assess any changes in cognition, self-esteem, perceived physical value, quality of life, social functioning, negative symptoms, and self-stigmatization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

May 21, 2026

Last Update Submit

June 5, 2026

Conditions

At-risk Mental StatesFirst Episode Psychosis (FEP)

Keywords

at-risk mental statesfirst episode psychosisphysical activityearly intervention

Outcome Measures

Primary Outcomes (1)

  • Subjective experiences in the social, academic/professional, clinical, and physical domains, 10-point visual Likert scale

    10-point visual Likert scale (ranging from 0 "not at all well" to 10 "very well") to assess participants' feelings before and after the intervention in the social, academic/professional, clinical, and physical domains, as well as their qualitative comments ("How do you feel in the … domain?"). A higher score means a better outcome.

    2 minutes

Secondary Outcomes (12)

  • Rappel Libre / Rappel Indicé - 16 (RL/RI-16).

    15 minutes

  • d2-R

    5 minutes

  • WAIS-IV Digit Span

    5 to 10 minutes

  • Trail Marking Tests TMT A and B

    2 minutes

  • WAIS-IV Coding

    5 to 10 minutes

  • +7 more secondary outcomes

Study Arms (2)

Group 1: Tennis + Self esteem program

EXPERIMENTAL

Participants in Group 1 took part in 8 tennis sessions and 6 self-esteem sessions.

Other: Tennis ( physical activity)Other: Self-esteem program

Group 2: self-esteem program

ACTIVE COMPARATOR

Participants in Group 2 only took part in 6 self-esteem sessions.

Other: Self-esteem program

Interventions

Tennis ( physical activity)OTHER

Eight tennis sessions, each lasting 1 hour and 15 minutes, led by a sports instructor specializing in tennis and a nurse case manager. The sessions took place at a tennis club.

Group 1: Tennis + Self esteem program
Self-esteem programOTHER

The self-esteem program is called "I'm Great!" by Tania Lecomte et al., and has been validated in early intervention settings. 6 sessions.

Group 1: Tennis + Self esteem programGroup 2: self-esteem program

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18 to 30 years diagnosed with at-risk mental state or first episode psychosis

You may not qualify if:

  • Motor disability
  • intellectual disability,
  • depression,
  • insufficient French language proficiency,
  • subject's refusal,
  • currently undergoing cognitive remediation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Esquirol

Limoges, 87025, France

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mirvat Hamdan-Dumont, MD, PhD

    Centre Hospitalier Esquirol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 8, 2026

Study Start

October 13, 2022

Primary Completion

August 26, 2024

Study Completion

August 26, 2024

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations

FR(1)