Effectiveness of a 3-month Individual Reminiscence Therapy Program in Older Adults With Alzheimer's Disease

NCT06812442 | Completed

• 1 other identifier: 01022025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

This research aims to evaluate the effectiveness of individual Reminiscence Therapy (RT) program, using a simple reminiscence format, to improve the overall cognitive function, mood, and quality of life (QoL) of older adults with mild to moderate Alzheimer's disease attending social care and support services. A multicentre randomised controlled trial (RCT) is proposed in Portugal with repeated measures (pre-intervention, and post-intervention). Intervention group will hold 26 individual RT sessions, twice a week for 13 weeks. Control group participants will maintain their treatment as usual. Make a subsample analysis of the main clinical diagnoses, and compare the results of sample and subsample with a previous study that had the same intervention protocol.

Conditions

Dementia; Alzheimer Disease; Cognitive Impairment

Keywords

older adults; reminiscence therapy; quality of life; mood; depression; anxiety; Alzheimer´s disease; non-pharmacological therapies; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Cognitive functioning evaluated through Mini-Mental State Examination (MMSE)

  MMSE is a widely used screening tool that evaluates cognitive domains such as orientation, attention, memory, language, and visual-spatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive functioning

  baseline

• Change in cognitive functioning evaluated through MMSE

  Cognitive functioning is assessed using the MMSE is a widely used screening tool that evaluates global cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.

  13 weeks after the beginning of the intervention

Secondary Outcomes (8)

• Mood assessed through the Geriatric Depression Scale-15 (GDS-15)

  baseline

• Change in mood assessed through the GDS-15

  13 weeks after the beginning of the intervention

• Anxiety symptomatology assessed through the Geriatric Anxiety Inventory (GAI)

  baseline

• Change in anxiety symptomatology assessed through the GAI

  13 weeks after the beginning of the intervention

• Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD)

  baseline

Other Outcomes (1)

• Sociodemographic information gathered through the sociodemographic questionnaire

  baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving Reminiscence Therapy (RT) or to a control group receiving only Treatment as Usual (TAU). Participants in the intervention group will participate in two RT sessions per week for 13 weeks besides their TAU. The sessions will be based on the Book of the Past and the Present and they will follow the same protocol in every participant site.

Other: Reminiscence therapy

Control Group

NO INTERVENTION

Participants assigned to the control group will maintain TAU in the site, participating in the activities previously assigned to their individual care plan.

Interventions

Reminiscence therapy OTHER

Intervention group will receive two RT sessions per week for 13 weeks. RT sessions will last approximately 50 minutes and will be developed according to the following structure: · Welcome to the patient and reality orientation therapy (7 minutes)· Conducting the main activity of reminiscence (40 minutes) · Closure, thank you for the participation and farewell until the next session (3 minutes). RT sessions will have an individual format and will be conducted by a therapist previously trained in the protocol and the principles of RT. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of the Past and the Present.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years or older.
• Receiving care and support services for at least three months.
• Diagnosis of probable Alzheimer's disease according to Diagnostic and Statistical Manual of Mental Disorders (DSM), fifth edition text revision criteria.
• Intact communication skills.
• Native Portuguese speaking.
• Signed informed consent by the participant.
• Mini Mental State Examination (MMSE) score between 10 and 24 points

You may not qualify if:

• Severe sensory and physical limitations.
• Acute or serious illness precluding participation in the RT sessions.
• Evidence of aggressive and disruptive behaviour, as observed by staff at the facility.
• Starting neuroleptics or antipsychotics within two months of recruitment.
• No literacy (educational level).

Sponsors & Collaborators

• Rsocialform - Geriatria, Lda: lead

Study Sites (4)

Centro Social e Paroquial de Brinches

Serpa, Beja District, 7830-137, Portugal

Location

Centro Social Remelhe D. António Barroso

Barcelos, Braga District, 4755-455, Portugal

Location

Associação de Socorros da Freguesia Turcifal

Torres Vedras, Lisbon District, 2565-785, Portugal

Location

Fundação João Bento Raimundo

Guarda, 6300-659, Portugal

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Cognitive Dysfunction; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cognition Disorders; Behavioral Symptoms; Behavior

Study Officials

• Susana I. Justo Henriques, PhD

  Polytechnic University of Beja

  STUDY DIRECTOR

• Célia C Silva, BsC

  Polytechnic University of Beja

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: February 1, 2025
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (4)