NCT07690098

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 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 19, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 16, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

Psychosocial interventionMental DisorderOlder adults

Outcome Measures

Primary Outcomes (2)

  • WHO Self-Directed Ageism Scale (15-item)

    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)

    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)

Secondary Outcomes (2)

  • Self-Compassion Scale (SCS-12)

    Baseline, Week 10 (end of intervention)

  • Perception of Aging

    Baseline and Week 10 (end of intervention)

Other Outcomes (4)

  • Recovery Assessment Scale (RAS-24)

    Baseline and Week 10 (end of intervention)

  • Symptom Checklist-45 abbreviated version

    Baseline and Week 10 (end of intervention)

  • Protocol adherence form

    At the end of each session, weekly from Week 1 to Week 10

  • +1 more other outcomes

Study Arms (2)

AgingUP (Self-Ageism Reduction Program)

EXPERIMENTAL

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.

Behavioral: AgingUP (Self-Ageism Reduction Program)

Waiting list

EXPERIMENTAL

Participants continue with the treatment as usual provided at their center during the 10-week control period and are offered the AgingUP program afterward.

Behavioral: AgingUP (Self-Ageism Reduction Program)

Interventions

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.

AgingUP (Self-Ageism Reduction Program)Waiting list

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNINPSI

Madrid, Madrid, 28036, Spain

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Macarena Sánchez-Izquierdo, PhD

    Universidad Pontificia Comillas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: AgingUP is a 10-session psychosocial group intervention for older adults (≥50 years) with Severe Mental Illness (SMI), designed to reduce self-ageism and self-stigma and to promote positive and realistic views of aging. It integrates Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, self-compassion training, and positive narrative work, and is delivered alongside the treatment as usual provided at participants' centers. The control group continues with treatment as usual and is offered AgingUP afterward (waiting list). Assessments are conducted at baseline (E1) and immediately after the 10-week program (E2), covering self-directed ageism, self-stigma, self-compassion, recovery, perceptions of aging, and general symptomatology. This pilot will provide preliminary evidence on feasibility, acceptability, and preliminary effects.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2026

First Posted

July 8, 2026

Study Start

October 19, 2025

Primary Completion

December 17, 2025

Study Completion

December 17, 2025

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations