Multicentre Study About the Effect of Individual Reminiscence Therapy

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effect of individual reminiscence therapy (RT) on the global cognitive function of people with neurocognitive disorders attending social responses and to evaluate the ability of individually applied reminiscence therapy (RT) to improve overall cognitive function, memory, executive function, mood and quality of life (QoL) of elderly people with neurocognitive impairment attending social responses. It is proposed a multicenter study with an experimental design with randomized controlled repeated measures. Participants in the intervention group will hold two RT sessions per week for three months. Control group participants will maintain their treatment as usual.

Detailed Description
-----------------
Neurocognitive disorder is a major cause of disability among older people and its incidence is increasing due to an aging population. Neurocognitive disorders globally are estimated to affect 44.35 million people and it is expected that by the year 2050 the number of affected people globally will triple to 135.46 million. The absence of effective pharmacological treatment that stops or slows down the development of the disease has aroused interest in non-pharmacological therapies as a complement to pharmacological treatment that may improve the quality of life of people with neurocognitive disorders. One of the most investigated and most traditional non-pharmacological therapy in this field is Reminiscence Therapy (RT). RT involves discussing past activities, events and experiences, usually with the help of triggers, such as photographs, household objects and other familiar items from the past, music… that is, any object or stimulus that serves to stimulate remembrance. In its application to dementia, RT is based on the fact that the memory impairment of people with dementia means that they are able to recall events from their past life, especially from childhood to early adulthood, but cannot remember more recent facts. It focuses on preserved memories and abilities, promotes communication, and enables the person to connect with his/her past and regain his/her sense of personal identity. Thus, RT can be understood as an intervention on the edge of those of cognitive orientation and emotion-centered, with potential interactive effects on autobiographical memory and psychological well-being. The investigators can distinguish at least two RT approaches. The first one is the life review where participants are guided through meaningful experiences from their biography trying to make sense of their life. This type of RT is more structured and is usually conducted in an individual format. It may imply the construction of life books. This approach is considered to have an integrative function aimed at achieving a sense of validation, coherence and reconciliation with the person's past. Another approach is the simple reminiscence which involves the stimulation of autobiographical memory during conversations about specific themes of the past (such as holidays, food and drinks, work…) using stimuli that trigger memories. It has been described as an unstructured narrative of autobiographical memories. This reminiscence format can be conducted both individually and in groups and promotes communication between participants who share their memories and stories. In any of the TR formats it is essential to introduce triggering stimuli (photographs, music, antique objects…) to aid in recall. These triggers may be generic, reflecting common experiences in the lives of people relevant to their age group (for example a textbook may serve to recall the experience during their school stage), or specific, with stimuli related to the individual's own experiences (for example photographs of an important life event such as your wedding day or a trip during your youth). Regarding the effectiveness of RT, according to a recent Cochrane review, there is some evidence for its positive effects on cognition, QoL, communication, and possibly mood of people with dementia, although benefits are small. Despite the distinction between the two different approaches to RT (simple reminiscence vs. life review), the modality of therapy does not seem to be as important for positive effects as the individual or group format of the sessions and the context in which the intervention is administered (people who live in the community or people who are institutionalized). According to the results of one review study, RT seems to be able to generate a small benefit on cognitive function immediately after the intervention, although it usually does not persist after a follow-up period. Regarding the administration format, individual RT effects seems slightly superior on cognition both immediately and after a follow-up period. In any case, its effects appear to be comparable to those of other cognitive stimulation therapies. As for the effect of RT on QoL, a life-review-based individual RT study showed an improvement in Qol-AD. Effects with a group format do not seem consistent, showing little or no effect on QoL, although the key factor may be the application context (community vs. institution), with better results of group RT in institutionalized patients. Group RT was associated with an effect on communication both after the intervention and at follow-up. This effect was not replicated in individual RT, with uncertain results. Finally, despite evidence of the effect of RT on mood of older people without dementia, in the case of people with dementia only a small effect on mood was found for those participants. in individual RT. Therefore, this research proposal aims to evaluate the ability of individual RT using a simple reminiscence format to improve the overall cognitive function, memory, executive function, mood and quality of life (QoL) of people with neurocognitive disorder attending social responses for the elderly.

Official Title
-----------------
Multicentre Randomized Controlled Study About the Effect of Individual Reminiscence Therapy on Cognition in Elderly People With Neurocognitive Disorder Attending Social Responses

Conditions
-----------------
Cognitive Impairment, Cognitive Decline, Dementia, Neurocognitive Disorders

Intervention / Treatment
-----------------
* Other: Reminiscence Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a diagnostic of a neurocognitive disorder according to the DSM-5 criteria. To have delivered the informed consent of the project, duly completed and signed, after prior information Capacity to communicate and understand. Possibility of gathering information about the participant's life history through their relatives or habitual caregivers, using the socio-familiar questionnaire design for that purpose. Being 65 years of age or older. Being a native Portuguese speaker. Regularly attend a social response institution that provides services for the elderly. Exclusion Criteria: To suffer from an acute or severe illness that makes it impossible for them to participate in the intervention sessions. Serious sensory and physical limitations that prevent the participation in the sessions. Severe disconnection with the environment and very limited attention span. Presence of severe neuropsychiatric symptoms, such as hyperactivity, psychosis, severe depressive and anxiety symptoms and apathy, that prevent participation in the sessions or presence of uncontrolled delirium. Traumatic life history or marked by negative events relevant to the person that discourage the participation in the Reminiscence Therapy sessions. History of negative reactions during previous Reminiscence Therapy sessions or similar activities.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants who meet the inclusion criteria will be randomly assigned to the intervention group receiving Reminiscence Therapy or to a control group receiving treatment as usual. Participants in the intervention group will participate in two Reminiscence Therapy sessions per week for 3 months besides their treatment as usual. The sessions will be based on the Book of Past and Present and they will follow the same protocol in every participant institution. | Other: Reminiscence Therapy<br>* Intervention group will receive two Reminiscence Therapy sessions per week for 3 months. Reminiscence therapy 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) Reminiscence therapy sessions will have an individual format and will be conducted by a therapist previously trained in the protocol and the principles of Reminiscence Therapy. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of Past and Present.<br>|
| No Intervention: Control Group<br>Participants assigned to the control group will maintain their usual treatment in the institution, participating in the activities previously assigned to their individual care plan. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functioning evaluated through Mini-Mental State Examination | Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Mini-Mental State Examination is a brief cognitive screening test. Scores range between 0 - 30 points. Higher scores indicate better cognitive function. | Pre and post-intervention (3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory funtion evaluated through Memory Alteration Test | Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Memory Alteration Test is an easy and fast instrument that assesses five memory domains: orientation in time, short term memory, semantic memory, free recall and recall with clues. Scores range between 0 - 50 points. Higher scores indicate better memory. | Pre and post-intervention (3 months) | 
| Executive functions evaluated through Frontal Assessment Battery | Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Frontal Assessment Battery assesses executive functions such as abstract thinking, mental flexibility, motor programming, interference sensibility, inhibitory control and environmental independence. Scores range between 0 - 18 points. Higher scores indicate better cognitive function. | Pre and post-intervention (3 months) | 
| Mood evaluated through Geriatric Depression Scale -15 | Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Geriatric Depression Scale -15 is composed by 15 yes/no answer items and it has good psychometric characteristics to assess depression in older people. Scores range between 0 - 15 points. Higher scores indicate more severe depressive symptoms. | Pre and post-intervention (3 months) | 
| Quality of life evaluated through Quality of Life - Alzheimer's Disease | Significant statistic improvement in the participant's test scores between pre-intervention assessment and post-intervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychossocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life. | Pre and post-intervention (3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Cognitive Impairment, Cognitive Decline, Neurocognitive Disorders, Elderly, Reminiscence Therapy, Individual Intervention, Cognition, Depression, Quality of Life