Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05186337
Status:
RECRUITING
Last Update Posted:
2023-09-25
First Post:
2021-12-15
Brief Title:
Functional Remediation for Older Adults With Bipolar Disorder
Sponsor:
Consorcio Centro de Investigación Biomédica en Red CIBER
Organization:
Consorcio Centro de Investigación Biomédica en Red CIBER
Study Overview
Official Title:
Efficacy of Functional Remediation for Older-Age Patients With Bipolar Disorder FROA-BD as Adjuntive to Pharmacological Treatment Versus Treatment as Usual TAU
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FROA-BD
Brief Summary:
Bipolar Disorder BD is a chronic and severe mental illness characterized by the emergence of alternating mood episodes which range from extreme depression to manic states Beyond affective episodes there is consensus considering that cognitive and functional impairment are also core features in a substantial proportion of patients suffering from this mental condition being both of them responsible of a negative impact on perceived quality of life QoL Despite the association between cognitive performance clinical and functioning outcomes in patients with BD has been largely explored among adult and middle-aged patients there is a dearth of research about aging process among older adults with bipolar disoder OABD as well as in the design of tailored intervention targeting older individuals Due to the longer life expectancy and subsequent aging of the worlds population is becoming increasingly common that people presenting with chronic health condition including BD survives longer Currently it has been estimated roughly the 25 of whole BD population is over 60 years old and it is expected that this percentage will increase up to 50 by 2030 Consequently there is an urgent need not only to explore specific implication in clinical and neurocognitive course and to investigate symptom development throughout this vital stage elder-life phase but also to design specific interventions aimed to cope with special needs in this specific population
Detailed Description:
Study design This is a single-center single-blind randomized controlled test-retest clinical study to evaluate the efficacy of the FROA-BD in a representative sample of patients with BD over 60 years old This study will be carried out in the Bipolar and Depressive Disorders Unit at the Hospital Clinic of Barcelona which takes part of the Spanish network Center for Biomedical Research in Mental Health CIBERSAM0029 It will include two parallel arms 11 in order to assess the efficacy of a new psychological intervention as add-on therapy compared with treatment as usual to enhance functional outcome in OABD This project has been approved by the Ethical Comittee of the Hospital Clinic of Barcelona and it will be carried up in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice in compliance with the data protection law in force and anonymization of the collected information
Procedure All participants will be examined at baseline prior to inclusion in the study using an extensive battery of questionnaires and tools aimed to assess main demographic clinical functioning quality of life well-being and neurocognitive variables Once the baseline assessment has been carried out patients will be randomly allocated into the experimental group which will receive the FROA-BD programme or to the control group which will be treated as usual TAU Four months later when the intervention will be finished all study participants will be assessed especially on those areas that are supposed to be targeted by the FROA-BD programme functional outcome as the main outcome and neurocognitive performance clinical symptoms and quality of life and well-being as secondary outcomes trying to avoid potential re-assessment learning effect by using alternative versions or tests Finally one year after inclusion 8 months after completion of the intervention a complete assessment mostly identical to which was used at baseline will be performed See Figure 1 In addition to the aforementioned assessment visits all participants will also be followed up pharmacologically at the Bipolar and Depressive Disorder Unit of the Hospital Clinic of Barcelona following the guidelines of good clinical practice Research members involved in assessment will be blind to condition group FROA-BD or TAU Two clinical neuropsychologist therapist and co-therapist blind to baseline assessment results will conduct the FROA-BD intervention
Data collection
1 Demographic clinical variables and comorbidity A semi-structured clinical interview based on the SCID-5 will be administered to gather main demographic and clinical variables The HDRS and the YMRS will be used to evaluate the presence of depressive and manic symptomatology respectively The Cumulative Illness Rating Scale-Geriatrics CIRS-G Spanish version will be administered in order to assess the presence of any somatic comorbid condition Medical records will be also reviewed and considered
2 Psychosocial functioning quality of life and well-being Functional outcome will be assessed by the means of the FAST This interviewer-administered brief scale which comprises 24 items was specifically designed to explore functional difficulties in psychiatric population among six specific functional domains autonomy occupational functioning cognitive functioning financial issues interpersonal relationships and leisure time Overall scores range from 0 to 72 being higher scores indicators of a worse functional impairment
Quality of life and well-being will be assessed using the Spanish version of the Short Form-36 Health Survey SF-36 and the Spanish version of the World Health Organisation-Five Well-Being Index WHO-5 respectively The SF-36 is self-administered questionnaire which consists of 36 questions measuring eight separate dimensions related to quality of life physical functioning role limitation-physical role limitation-emotional vitality mental health social functioning pain and general health Higher scores indicate better quality of life WHO-5 is a self-administered short test consisting of 5 items rated on a 6-point scale assessing how the individual has been feeling over the last two weeks Raw score ranges from 0 to 25 The higher scores the better perceived subjective well-being In order to obtain the feedback from the patients we also will consider the patients satisfaction with the intervention through a self-applied instrument measured in likert scale from 0 to 10 where the maximum score corresponds to completely satisfied
3 Cognitive Reserve The Cognitive Reserve Assessment Scale in Health CRASH is an interviewer-administered quick and easy-to-apply tool which was designed to evaluate cognitive reserve in psychiatric patients especially in those suffering from severe mental conditions This 23-item scale assess the three domains education occupation and intellectual and leisure activities which are the main domains involved in cognitive reserve This scale provides an overall score as well as a score for each assessed domain The maximum score is 90 Higher scores indicate higher cognitive reserve
4 Neuropsychological assessment In this study we will to assess cognitive performance both from the subjective and objective perspective For gathering data regarding subjective cognitive complaints we will use the Cognitive Complaints in Bipolar Disorder Rating Assessment COBRA This self-administered instrument consist of 16 items which are rated on a 4-point scale 0 never 1 sometimes 2 frequently 3 always COBRA total score results is calculated by totaling all item scores and higher scores indicate a worse subjective cognitive performance
For the objective assessment of neurocognitive function two different batteries of tests have been selected depending of time-point assessment
I Extended battery Overall cognition will be assessed by means of the Mini Mental Status Examination MMSE and the Spanish version of the Screen for Cognitive Impairment in Psychiatry SCIP-S Both of these brief scales were specifically designed for detecting cognitive deficits being the latter specific for psychiatric population The SCIP-S has three alternative forms as three different time-points of the study in order to avoid learning effect bias
The estimated Intelligence quotient IQ will be calculated based on the results in the Vocabulary subtest from the Wechsler Adult Intelligence Scale WAIS-III
The Executive functions will be measured through the computerized Wisconsin Card Sorting Test WSCT the Stroop Color-Word Test SCWT the Phonemic F-A-S component of the Controlled Oral Word Association Test COWAT the copy of the Rey Osterrieth Complex Figure ROCF and the Trail Making Test-Part B TMT-B
Attention will be assessed by using the computerized version of the Continuous Performance Test CPT-II and the Trail Making Test-Part A TMT-A
The Working memory index WM will be calculated based on the performance in three subtest from the WAIS-III Arithmetic Digits and Letter-Number sequencing
The assessment of the Processing speed index will comprise two subtests of the WAIS-III the Symbol Search and the Digit-symbol Coding subtests from the WAIS-III
Verbal Learning and Memory performance will be evaluated through the California Verbal Learning Test CVLT
To examine visual memory The Rey Osterrieth Complex Figure-inmediate recall ROCF will be administered
Language domain will be examined by means of the Boston Naming Test BNT and the Categorical Animal Naming component of the COWAT
Visuoespatial domain will be assessed by the Juice Line Orientation JLO This battery will be administered at baseline visit V0 and 12-month follow-up visit after inclusion V2 with the exception of vocabulary subtest which only will be applied at baseline visit since it is a measure of estimated IQ
II Brief cognitive battery In order to avoid potential learning effects we selected a brief cognitive battery consisting of the SCIP-S form 2 the SCWT the TMT part A and B the CPT-II and the semantic and phonemic components of the COWAT This brief battery of test will be administered at post-intervention visit V1 four months after inclusion
Procedure All participants will be examined at baseline prior to inclusion in the study using an extensive battery of questionnaires and tools aimed to assess main demographic clinical functioning quality of life well-being and neurocognitive variables Once the baseline assessment has been carried out patients will be randomly allocated into the experimental group which will receive the FROA-BD programme or to the control group which will be treated as usual TAU Four months later when the intervention will be finished all study participants will be assessed especially on those areas that are supposed to be targeted by the FROA-BD programme functional outcome as the main outcome and neurocognitive performance clinical symptoms and quality of life and well-being as secondary outcomes trying to avoid potential re-assessment learning effect by using alternative versions or tests Finally one year after inclusion 8 months after completion of the intervention a complete assessment mostly identical to which was used at baseline will be performed See Figure 1 In addition to the aforementioned assessment visits all participants will also be followed up pharmacologically at the Bipolar and Depressive Disorder Unit of the Hospital Clinic of Barcelona following the guidelines of good clinical practice Research members involved in assessment will be blind to condition group FROA-BD or TAU Two clinical neuropsychologist therapist and co-therapist blind to baseline assessment results will conduct the FROA-BD intervention
Data collection
1 Demographic clinical variables and comorbidity A semi-structured clinical interview based on the SCID-5 will be administered to gather main demographic and clinical variables The HDRS and the YMRS will be used to evaluate the presence of depressive and manic symptomatology respectively The Cumulative Illness Rating Scale-Geriatrics CIRS-G Spanish version will be administered in order to assess the presence of any somatic comorbid condition Medical records will be also reviewed and considered
2 Psychosocial functioning quality of life and well-being Functional outcome will be assessed by the means of the FAST This interviewer-administered brief scale which comprises 24 items was specifically designed to explore functional difficulties in psychiatric population among six specific functional domains autonomy occupational functioning cognitive functioning financial issues interpersonal relationships and leisure time Overall scores range from 0 to 72 being higher scores indicators of a worse functional impairment
Quality of life and well-being will be assessed using the Spanish version of the Short Form-36 Health Survey SF-36 and the Spanish version of the World Health Organisation-Five Well-Being Index WHO-5 respectively The SF-36 is self-administered questionnaire which consists of 36 questions measuring eight separate dimensions related to quality of life physical functioning role limitation-physical role limitation-emotional vitality mental health social functioning pain and general health Higher scores indicate better quality of life WHO-5 is a self-administered short test consisting of 5 items rated on a 6-point scale assessing how the individual has been feeling over the last two weeks Raw score ranges from 0 to 25 The higher scores the better perceived subjective well-being In order to obtain the feedback from the patients we also will consider the patients satisfaction with the intervention through a self-applied instrument measured in likert scale from 0 to 10 where the maximum score corresponds to completely satisfied
3 Cognitive Reserve The Cognitive Reserve Assessment Scale in Health CRASH is an interviewer-administered quick and easy-to-apply tool which was designed to evaluate cognitive reserve in psychiatric patients especially in those suffering from severe mental conditions This 23-item scale assess the three domains education occupation and intellectual and leisure activities which are the main domains involved in cognitive reserve This scale provides an overall score as well as a score for each assessed domain The maximum score is 90 Higher scores indicate higher cognitive reserve
4 Neuropsychological assessment In this study we will to assess cognitive performance both from the subjective and objective perspective For gathering data regarding subjective cognitive complaints we will use the Cognitive Complaints in Bipolar Disorder Rating Assessment COBRA This self-administered instrument consist of 16 items which are rated on a 4-point scale 0 never 1 sometimes 2 frequently 3 always COBRA total score results is calculated by totaling all item scores and higher scores indicate a worse subjective cognitive performance
For the objective assessment of neurocognitive function two different batteries of tests have been selected depending of time-point assessment
I Extended battery Overall cognition will be assessed by means of the Mini Mental Status Examination MMSE and the Spanish version of the Screen for Cognitive Impairment in Psychiatry SCIP-S Both of these brief scales were specifically designed for detecting cognitive deficits being the latter specific for psychiatric population The SCIP-S has three alternative forms as three different time-points of the study in order to avoid learning effect bias
The estimated Intelligence quotient IQ will be calculated based on the results in the Vocabulary subtest from the Wechsler Adult Intelligence Scale WAIS-III
The Executive functions will be measured through the computerized Wisconsin Card Sorting Test WSCT the Stroop Color-Word Test SCWT the Phonemic F-A-S component of the Controlled Oral Word Association Test COWAT the copy of the Rey Osterrieth Complex Figure ROCF and the Trail Making Test-Part B TMT-B
Attention will be assessed by using the computerized version of the Continuous Performance Test CPT-II and the Trail Making Test-Part A TMT-A
The Working memory index WM will be calculated based on the performance in three subtest from the WAIS-III Arithmetic Digits and Letter-Number sequencing
The assessment of the Processing speed index will comprise two subtests of the WAIS-III the Symbol Search and the Digit-symbol Coding subtests from the WAIS-III
Verbal Learning and Memory performance will be evaluated through the California Verbal Learning Test CVLT
To examine visual memory The Rey Osterrieth Complex Figure-inmediate recall ROCF will be administered
Language domain will be examined by means of the Boston Naming Test BNT and the Categorical Animal Naming component of the COWAT
Visuoespatial domain will be assessed by the Juice Line Orientation JLO This battery will be administered at baseline visit V0 and 12-month follow-up visit after inclusion V2 with the exception of vocabulary subtest which only will be applied at baseline visit since it is a measure of estimated IQ
II Brief cognitive battery In order to avoid potential learning effects we selected a brief cognitive battery consisting of the SCIP-S form 2 the SCWT the TMT part A and B the CPT-II and the semantic and phonemic components of the COWAT This brief battery of test will be administered at post-intervention visit V1 four months after inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None