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AgingUP: A Pilot Program to Reduce Self-Ageism and Self-Stigma in Older Adults With Severe Mental Illness (AgingUp)

1 luglio 2026 aggiornato da: Macarena Sánchez-Izquierdo Alonso, Universidad Pontificia Comillas

AgingUP: A Pilot Psychosocial Program to Reduce Self-Ageism and Self-Stigma and Foster Positive and Realistic Views of Aging in Older Adults With Severe Mental Illness

The goal of this pilot clinical trial is to learn whether AgingUP, a 10-session psychosocial program, helps reduce self-ageism and self-stigma and fosters more positive and realistic views of aging in older adults (≥50 years) living with severe mental illness.

The main questions it aims to answer are:

  • Does participation in AgingUP reduce self-directed ageism compared to usual care?
  • Does it reduce internalized stigma related to mental illness?
  • Does it increase self-compassion?
  • Does it improve their perception of their own aging? Researchers will compare the AgingUP group with a control group receiving treatment as usual to see if participants in AgingUP show more adaptive perceptions of aging and self-concept.

Participants will:

  • Attend 10 weekly group sessions (60-75 min each) focused on cognitive-behavioral techniques, acceptance and commitment strategies, self-compassion exercises, and empowerment (as a transversal element).
  • Complete brief questionnaires about their experiences and attitudes before and after the program.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This research aims to generate preliminary evidence on the feasibility and potential effectiveness of AgingUP, a 10-session psychosocial program designed to reduce self-ageism and self-stigma and to foster more positive and realistic views of aging among older adults with severe mental illness (SMI). The program integrates Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), self-compassion training, positive narrative work, and social support.

The intervention is structured to progressively build cognitive, emotional, and social skills. The initial sessions provide psychoeducation and cognitive restructuring to help participants identify and challenge negative thoughts related to aging and mental illness. Mid-program sessions introduce values clarification and committed action from ACT, encouraging participants to act in alignment with personally meaningful goals. Later sessions focus on cultivating self-compassion and reconstructing positive life narratives that counter internalized stereotypes. The program concludes with a session on social connection and maintenance strategies.

AgingUP is implemented in group format within residential settings and compared to a control group receiving treatment as usual. Participants complete assessments at baseline and immediately after the 10-week intervention. The study will examine changes in self-directed ageism, self-stigma, self-compassion, symptoms, recovery and perception of successful aging.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

36

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
    • Madrid
      • Madrid, Madrid, Spagna, 28036
        • UNINPSI

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

Age: ≥ 50 years (preventive/therapeutic focus on early and late aging in Severe Mental Illness).

Diagnosis: Having a clinical diagnosis of Severe Mental Illness (SMI) such as schizophrenia, bipolar disorder, psychotic spectrum disorders, or severe affective disorders.

Active Treatment: Currently receiving psychiatric or psychosocial treatment in a mental health center, rehabilitation unit, or community service.

Legal Status: Not having a court-appointed legal representative. Voluntariness: Participation must be completely voluntary, without coercion or obligation.

Language and Communication: Able to communicate in the language used for the study/intervention (e.g., Spanish).

Availability: Willing to attend the scheduled sessions and activities according to the study/intervention design.

Exclusion Criteria:

  • Severe Cognitive Impairment: Presence of advanced dementia or severe neurodegenerative disease that limits understanding or informed consent.

Active Psychiatric Crisis: Experiencing an acute psychotic episode, manic crisis, or severe depression with high suicide risk at the time of assessment.

Severe Medical Conditions: Having medical illnesses that prevent participation in study activities.

Concurrent Study Participation: Participation in another ongoing study that may interfere with the objectives of this intervention.

Legal Incapacity: Having a legal incapacity that prevents free and voluntary participation.

Severe Cognitive Difficulties: Difficulties that significantly impair understanding of information or participation in group or digital activities.

Language Barrier: Inability to understand the language in which the intervention is conducted, limiting comprehension of study content.

Informed Consent: Failure to sign the informed consent form or expressing significant doubts about voluntary participation.

Lack of Availability: Unwillingness or inability to attend the sessions according to the structure and duration of the study.

Concurrent Participation: Participation in another study that could interfere with the goals of this intervention.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: AgingUP (Self-Ageism Reduction Program)
Participants receive the AgingUP program, a 10-session psychosocial group intervention combining CBT, ACT, self-compassion training, and positive narrative work, in addition to the treatment as usual provided at their center.
Comportamentale: AgingUP (Self-Ageism Reduction Program)
AgingUP is a 10-session psychosocial group intervention combining Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), self-compassion training, and positive narrative work. Sessions focus on identifying and changing negative beliefs about aging and mental illness and on promoting more positive and realistic views of aging. It is delivered in addition to the treatment as usual provided at the participants' center.
Sperimentale: Waiting list
Participants continue with the treatment as usual provided at their center during the 10-week control period and are offered the AgingUP program afterward.
Comportamentale: AgingUP (Self-Ageism Reduction Program)
AgingUP is a 10-session psychosocial group intervention combining Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), self-compassion training, and positive narrative work. Sessions focus on identifying and changing negative beliefs about aging and mental illness and on promoting more positive and realistic views of aging. It is delivered in addition to the treatment as usual provided at the participants' center.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
WHO Self-Directed Ageism Scale (15-item)
Lasso di tempo: Baseline, Week 10 (end of intervention)
The scale evaluates self-directed ageism, defined as internalized stereotypes, prejudice, and discrimination related to one's own age. It includes 15 items rated on a 6-point Likert-type scale (from strongly disagree to strongly agree). Higher scores indicate higher levels of self-ageism.
Baseline, Week 10 (end of intervention)
Internalized Stigma of Mental Illness Scale (ISMI-29)
Lasso di tempo: Baseline, Week 10 (end of intervention)
The ISMI-29 evaluates self-stigma associated with mental illness. It comprises 29 items rated on a 4-point Likert scale (from strongly disagree to strongly agree). The scale assesses five domains: alienation, stereotype endorsement, discrimination experience, social withdrawal, and resistance to stigma. Higher scores indicate greater internalized stigma.
Baseline, Week 10 (end of intervention)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Self-Compassion Scale (SCS-12)
Lasso di tempo: Baseline, Week 10 (end of intervention)
The scale evaluates self-compassion, defined as a kind, understanding, and mindful attitude toward oneself in times of suffering. It includes 12 items rated on a 5-point Likert-type scale (from almost never to almost always). Higher scores indicate greater self-compassion.
Baseline, Week 10 (end of intervention)
Perception of Aging
Lasso di tempo: Baseline and Week 10 (end of intervention)
This measure assesses participants' subjective perception of aging through three items: (1) a 10-point scale of perceived successful aging, (2) a 5-point Likert item ("I am aging well"), and (3) self-reported perceived physical and mental age. Higher ratings indicate more positive perceptions of aging.
Baseline and Week 10 (end of intervention)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Recovery Assessment Scale (RAS-24)
Lasso di tempo: Baseline and Week 10 (end of intervention)
The scale assesses personal recovery in individuals with mental illness. It contains 24 items scored on a 5-point Likert-type scale (from strongly disagree to strongly agree), evaluating five dimensions: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no domination by symptoms. Higher scores indicate a stronger sense of recovery.
Baseline and Week 10 (end of intervention)
Symptom Checklist-45 abbreviated version
Lasso di tempo: Baseline and Week 10 (end of intervention)
This scale evaluates psychological symptoms using 45 items rated on a Likert-type scale from 0 to 4 (Not at all - Very much or extremely). It assesses 9 domains (Depression, Hostility, Interpersonal Sensitivity, Somatization, Anxiety, Psychoticism, Obsession-Compulsion, Phobic Anxiety, and Paranoid Ideation). Mean scores range from 0 to 4. A higher score indicates more intense symptoms.
Baseline and Week 10 (end of intervention)
Protocol adherence form
Lasso di tempo: At the end of each session, weekly from Week 1 to Week 10
At the end of each session, the group therapists complete a 10-item inventory rating the fulfillment of the session's objectives on a 3-point Likert-type scale (0 = not achieved, 1 = partially achieved, 2 = fully achieved).
At the end of each session, weekly from Week 1 to Week 10
Participants' satisfaction was measured by the Client Satisfaction Questionnaire (CSQ-8, Larsen et al., 1979)
Lasso di tempo: Week 10 (end of intervention)
The CSQ-8 is an 8-item measure assessing general satisfaction with the group on a 4-point Likert-type scale from 1 to 4 (very dissatisfied - very satisfied). Mean scores range from 1 to 4. Higher scores indicate higher satisfaction.
Week 10 (end of intervention)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Pontificia Comillas

Investigatori

  • Investigatore principale: Macarena Sánchez-Izquierdo, PhD, Universidad Pontificia Comillas

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 ottobre 2025

Completamento primario (Effettivo)

17 dicembre 2025

Completamento dello studio (Effettivo)

17 dicembre 2025

Date di iscrizione allo studio

Primo inviato

16 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2026

Primo Inserito (Effettivo)

8 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PHS-2024/PH-HUM-169

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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