- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07690098
AgingUP: A Pilot Program to Reduce Self-Ageism and Self-Stigma in Older Adults With Severe Mental Illness (AgingUp)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Madrid
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Madrid, Madrid, Spanien, 28036
- UNINPSI
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Eksperimentel: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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WHO Self-Directed Ageism Scale (15-item)
Tidsramme: Baseline, Week 10 (end of intervention)
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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.
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Baseline, Week 10 (end of intervention)
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Internalized Stigma of Mental Illness Scale (ISMI-29)
Tidsramme: Baseline, Week 10 (end of intervention)
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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.
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Baseline, Week 10 (end of intervention)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Self-Compassion Scale (SCS-12)
Tidsramme: Baseline, Week 10 (end of intervention)
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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.
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Baseline, Week 10 (end of intervention)
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Perception of Aging
Tidsramme: Baseline and Week 10 (end of intervention)
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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.
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Baseline and Week 10 (end of intervention)
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Recovery Assessment Scale (RAS-24)
Tidsramme: Baseline and Week 10 (end of intervention)
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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.
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Baseline and Week 10 (end of intervention)
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Symptom Checklist-45 abbreviated version
Tidsramme: Baseline and Week 10 (end of intervention)
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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.
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Baseline and Week 10 (end of intervention)
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Protocol adherence form
Tidsramme: At the end of each session, weekly from Week 1 to Week 10
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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).
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At the end of each session, weekly from Week 1 to Week 10
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Participants' satisfaction was measured by the Client Satisfaction Questionnaire (CSQ-8, Larsen et al., 1979)
Tidsramme: Week 10 (end of intervention)
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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.
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Week 10 (end of intervention)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Macarena Sánchez-Izquierdo, PhD, Universidad Pontificia Comillas
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PHS-2024/PH-HUM-169
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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