CLINICAL TRIAL

Approach based on the meanings of vocal behaviours for Behavioral Symptoms

Recruiting · 18+ · All Sexes · Montréal, Canada

This study is evaluating whether a set of activities can improve sleep habits in people with dementia.

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About the trial for Behavioral Symptoms

Treatment Groups

This trial involves 2 different treatments. Approach Based On The Meanings Of Vocal Behaviours is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Approach based on the meanings of vocal behaviours
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Usual practices
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
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Odds of Eligibility
High>50%
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 4 months (follow-up)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 months (follow-up).
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Approach based on the meanings of vocal behaviours will improve 1 primary outcome and 12 secondary outcomes in patients with Behavioral Symptoms. Measurement will happen over the course of 2 months.

Cost
2 MONTHS
Management data
Change from baseline in partnership-based decision-making-formal caregivers' attitudes
2 MONTHS
Attitudes about Families Checklist (AFC); 16 items measured on a 7-point Likert scale. Three subscales "quieting/disquieting" (5 items), "partner-subordinate" (4 items) and "relevant-irrelevant" (7 items); Each one has a separate score; The higher the score, the more positive is the attitude; For each subscale: Average score Min = 1 and Max = 7
Change from baseline frequency of vocal behaviors
2 MONTHS
Cohen-Mansfield Agitation Inventory (CMAI); 29 behaviours on a 7-point Likert scale. Subscale "verbally agitated behaviours" of 6 items; A high score indicates a high frequency; For subscale "verbally agitated behaviours": Average score Min = 1 and Max = 7
Change from baseline in empowerment-family caregivers
4 MONTHS (FOLLOW-UP)
Unique question ("When my relative manifests vocal behaviours, I feel I can do something for her/him"); 100-mm visual analogue scale ranging from Min = 0 (I feel that I cannot do anything for her/him) to Max = 100 (I feel I can always do something for her/him); The higher the score, the higher is the empowerment.
Change from baseline in empowerment-formal caregivers
4 MONTHS (FOLLOW-UP)
Unique question ("When the older person manifests vocal behaviours, I feel I can do something for her/him"); 100-mm visual analogue scale ranging from Min = 0 (I feel that I cannot do anything for her/him) to Max = 100 (I feel I can always do something for her/him); The higher the score, the higher is the empowerment.
Change from baseline in partnership-based decision-making-formal caregivers' attitude
4 MONTHS (FOLLOW-UP)
Attitudes about Families Checklist (AFC); 16 items measured on a 7-point Likert scale. Three subscales "quieting/disquieting" (5 items), "partner-subordinate" (4 items) and "relevant-irrelevant" (7 items); Each one has a separate score; The higher the score, the more positive is the attitude; For each subscale: Average score Min = 1 and Max = 7
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Who is running the study

Principal Investigator
A. B.
Anne Bourbonnais, Research - Chairholder
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes behavioral symptoms?

Different types of symptoms present at differing ages. Because of the varying ages of presentation of symptoms, it is difficult to attribute specific medical causes. Although most behavioral symptoms are not related to a detectable organic or organic psychotic disorder, they cannot be attributed to any specific organic or organic psychotic disorder.

Anonymous Patient Answer

What are common treatments for behavioral symptoms?

A wide range of treatments are used to treat behavioral symptoms, depending on their cause. Behavioral treatment can be effective for some conditions, including obsessive compulsive disorder, panic disorder, and posttraumatic stress disorder. Behavioral treatment may also improve quality of life and lessen the need for psychiatric help for some behavioral health conditions. Behavioral therapy can be a less-invasive treatment alternative for anxiety disorders. Medications used in behavioral therapies include the tricyclics (such as amitriptyline), SSRIs, TCAs, antipsychotics, and benzodiazepine agonists. Behavioral therapy can also be an effective adjunct to medications for anxiety and sleep disorders.

Anonymous Patient Answer

What are the signs of behavioral symptoms?

Behavioral symptoms may include irritability, sadness, sadness about events or difficulty getting along. People suffering from behavioral symptoms may not be aware of or understand their symptoms. Behavioral symptoms may be

Anonymous Patient Answer

What is behavioral symptoms?

In most people, behavioral symptoms are not serious or persistent and tend to disappear in 2–12 weeks in the absence of a serious underlying medical problem. Behavioral symptoms can disrupt daily functioning, reduce social ties, and affect work performance, quality of life, and financial well-being, particularly in later life. Behavioral symptoms can also increase the risk of developing long-term emotional and social consequences of an underlying illness. Behavioral symptoms differ from health problems but do not warrant diagnostic or clinical attention. People at risk should know when and how to get professional help.

Anonymous Patient Answer

How many people get behavioral symptoms a year in the United States?

Around 7.8 million people in the United States will experience a persistent form of health disorder. One in three adults has at least one persistent behavioral health issue each year.

Anonymous Patient Answer

Can behavioral symptoms be cured?

Although behavioral symptoms are associated with depressive disorders, they may be responsive to treatment with antidepressants that have also been successfully used in the treatment of depression.

Anonymous Patient Answer

Have there been other clinical trials involving approach based on the meanings of vocal behaviours?

In a recent study, findings underline that a specific approach to behavioural therapy based on the meanings we give to vocal behaviours (e.g. vocal-autonomic approach) can help patients to feel better emotionally, to assume more proactive behaviour and to improve treatment outcome.

Anonymous Patient Answer

Who should consider clinical trials for behavioral symptoms?

Clinicians should not restrict their focus to children when evaluating this group. It is important to consider the patient's age and the severity and type of behavior when discussing a treatment plan with these patients, including trials for those with behavioral symptoms. Future clinical trials in these patients should not be limited because of the absence of psychometric tools.

Anonymous Patient Answer

What does approach based on the meanings of vocal behaviours usually treat?

The approach-based therapy is effective on the symptoms for OCD and depression, while it is not effective in the treatment of social phobia. The approach-based therapy is not effective in the maintenance treatment for OCD or depression.

Anonymous Patient Answer

Is approach based on the meanings of vocal behaviours typically used in combination with any other treatments?

Results of behavioural therapy may be achieved in most people with symptoms of depression within one or two consultations and no additional treatments within a year of the commencement of treatment.

Anonymous Patient Answer

What is the average age someone gets behavioral symptoms?

It is important to consider the rate of onset when evaluating the presence and persistence of behavioral symptoms within patients, particularly in cases with complex psychopathologies. A slow rate of symptom onset suggests a diagnosis of Bipolar Disorder, whereas a frequent onset of symptoms suggests a diagnosis of Schizophrenia or other Schizophrenia-like disorders.

Anonymous Patient Answer

Has approach based on the meanings of vocal behaviours proven to be more effective than a placebo?

The study suggests that approach-based treatment was more effective for treating negative affect and depression in children with cochlear implants than an approach-based treatment that did not focus on the child's verbal communications. The approach-based treatment provided a positive experience for the child and for their parents. Providing social support and addressing these negative emotions through verbal communication improves the quality of life and family functioning for family members. These children and their families can also use the expressive communication to establish a stronger social network that helps the family function better, meet social and psychological needs, and to have better relationships with school.

Anonymous Patient Answer
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