Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2005 |
| End Date: | February 2015 |
Pilot Study of the Feasibility of a Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia
This is a pilot study evaluating the feasibility of a new family-based intervention for
schizophrenia. It is designed to help clients diagnosed with schizophrenia to overcome the
devastating effects of neurocognitive deficits on everyday functioning (Family-Directed
Cognitive Adaptation, FCA). Cognitive deficits in schizophrenia are known to contribute to
devastating functional impairments and caregiver burden, as clients rely on caregivers for
help with basic living needs, such as personal hygiene, time management, social skills, and
progress towards vocational and educational goals.
Specifically, we will 1) Develop a manualized, family treatment program designed to improve
adaptive functioning of patients with schizophrenia, and 2) Conduct a pilot feasibility
study to evaluate the acceptability and feasibility of this intervention, and to collect
preliminary outcome data. This will lay the foundation for a controlled trial of the
efficacy of the intervention. We expect that:
1. The FCA intervention will be well-received and well-tolerated by clients and families,
as demonstrated by a high level of interest in the program, a low rate of attrition,
and a high rate of participant satisfaction.
2. Client participants in the FCA intervention will show improvements in adaptive,
independent-living skills (e.g., personal hygiene and self-care, medication management,
time management, social skills, and responsibility for health maintenance) that will be
maintained three and six months following completion of the intervention.
3. Family members participating in the FCA program will show reduced burden of care and
time spent caregiving, greater satisfaction in their relationship with the client,
improved self-efficacy in the caregiver role, and reduced psychological distress (e.g.,
depression, anxiety, and hopelessness) at the completion of the program and at three
and six-month follow-up interviews.
schizophrenia. It is designed to help clients diagnosed with schizophrenia to overcome the
devastating effects of neurocognitive deficits on everyday functioning (Family-Directed
Cognitive Adaptation, FCA). Cognitive deficits in schizophrenia are known to contribute to
devastating functional impairments and caregiver burden, as clients rely on caregivers for
help with basic living needs, such as personal hygiene, time management, social skills, and
progress towards vocational and educational goals.
Specifically, we will 1) Develop a manualized, family treatment program designed to improve
adaptive functioning of patients with schizophrenia, and 2) Conduct a pilot feasibility
study to evaluate the acceptability and feasibility of this intervention, and to collect
preliminary outcome data. This will lay the foundation for a controlled trial of the
efficacy of the intervention. We expect that:
1. The FCA intervention will be well-received and well-tolerated by clients and families,
as demonstrated by a high level of interest in the program, a low rate of attrition,
and a high rate of participant satisfaction.
2. Client participants in the FCA intervention will show improvements in adaptive,
independent-living skills (e.g., personal hygiene and self-care, medication management,
time management, social skills, and responsibility for health maintenance) that will be
maintained three and six months following completion of the intervention.
3. Family members participating in the FCA program will show reduced burden of care and
time spent caregiving, greater satisfaction in their relationship with the client,
improved self-efficacy in the caregiver role, and reduced psychological distress (e.g.,
depression, anxiety, and hopelessness) at the completion of the program and at three
and six-month follow-up interviews.
This is an open trial designed to evaluate the feasibility of a new family intervention.
Participants will be assessed at baseline, post-intervention, and 3- and 6-months following
completion of the the intervention. A total of 20 clients diagnosed with schizophrenia,
schizoaffective disorder, or schizophreniform disorder and their families will be recruited
from the Massachusetts General Hospital Freedom Trail Clinic and the Beth Israel Deaconess
Medical Center (including,the Massachusetts Mental Health Center and the BIDMC inpatient and
outpatient departments). Clients and their families will participate in the Family-Directed
Cognitive Adaptation (FCA) intervention, including a functional assessment, 16 single-family
sessions and 6 sessions of a monthly, multiple-family group. Follow-up assessments will be
conducted by a clinical evaluator (who is not directly involved in the treatment) at the end
of the individual-family treatment and at about 3 and 6 months following completion of
treatment on all clients and relatives on a variety of outcome measures specified below
(timing of assessments may occasionally be delayed by about 1-4 weeks in order to
accommodate the schedules of clients and families). Sessions will be audiotaped for use in
the development of an instrument for measuring therapist fidelity to the treatment model.
Treatment Program.
The FCA program is designed to teach clients and families about neurocognitive deficits
associated with schizophrenia, recommend specific compensatory strategies and positive
behavioral supports for managing these deficits, and teach families to help the client to
implement these strategies in order to improve adaptive living skills. The FCA program will
begin with a comprehensive cognitive and functional assessment of the client and the home
environment in order to identify specific functional targets for the intervention. This will
include: 1) a neuropsychological assessment of attention, processing speed, memory and
executive functioning; 2) an assessment of independent living skills (e.g., time management,
grooming, self-care); and 3) a home assessment to identify barriers to adaptive functioning
in the client's home environment. Specific measures are described below and attached in the
Appendix.
Following the cognitive and functional assessments, clients and their relatives will receive
16 individual-family sessions (14 weekly sessions and 2 bi-weekly sessions—However, timing
of sessions may vary a bit to accommodate schedules of participants. We will aim to complete
the counseling sessions within 18-22 weeks), and 6 sessions of a monthly, multifamily group
(3-4 sessions will be concurrent with individual sessions, and 2-3 sessions will serve as
maintenance groups following the completion of the main, individual-family intervention).
The individual sessions in the FCA program will include: 1) general psychoeducation about
illness symptoms and cognitive deficits associated with schizophrenia (about 4 sessions), 2)
a feedback session presenting the results of the cognitive and functional assessment, and
identification of functional targets for the intervention, and 3) completion of 2-3 modules
targeting specific deficits in adaptive functioning that were identified during the
evaluation. Most sessions will be conducted at the clinic where the client receives
psychiatric treatment, but 3-4 home visits will also be conducted to facilitate modification
of the home environment and generalization of compensatory skills. Sessions will include the
client and at least one family member who lives with the client. The principal investigator
will serve as a clinician for this program along with a co-leader, and they will serve as
members of the client's clinical team.
Data to Be Recorded (Measures).
Clients and participating relatives will be assessed by a clinical evaluator (who is not
directly involved in the treatment) via structured interviews and self-report instruments at
four time points, including baseline, completion of the individual-family intervention, and
at about 3 and 6 months following completion of the intervention. (Timing of assessments may
vary a bit to accommodate schedules of participants. Therefore, follow-up one will take
place within 2 weeks after ending the 16 session program, follow-up two will take place
12-14 weeks, and follow-up three will take place between 12-14 weeks after the third
follow-up.)
Client measures.
Baseline measures will include an assessment of psychiatric diagnosis (SCID, chart review,
and collateral information gathered from the client's treating clinician and relatives) and
general demographic information. Clients will also undergo a neuropsychological evaluation
at baseline. This evaluation will consist of the MATRICS Provisional Consensus Cognitive
Battery Phase II. A brief selection of measures from this battery will be repeated at the
post-intervention assessment. Detailed descriptions of measures and copies of measures are
included in the Appendix.
Assessments at all time points (baseline, post-intervention, 3- and 6-month follow-up) will
include measures of symptoms (Brief Psychiatric Rating Scale, Scale for the Assessment of
Negative Symptoms, Positive and Negative Syndrome Scale), adaptive living skills and
functioning (Social Adaptive Functions Scale, Independent Living Skills Survey, Multnomah
Community Ability Scale, The Independent Living and Self-Care Skills Checklist, and the
Global Assessment of Functioning), behaviors related to cognitive functioning (Clinical
Global Impression of Cognition in Schizophrenia, Frontal Lobe Personality Scale—Patient
Version), and the degree to which the patient perceives their relatives as critical of them
(Interpersonal Affectivity Scale). Furthermore, chart reviews will be conducted to record
any inpatient hospitalizations that occur during the study period and number of days spent
in the hospital.
Family member measures. Baseline measures will include general demographic information (age,
ethnicity, level of education, etc). All assessments will include measures of negative
attitudes towards the client (Patient Rejection Scale, Interpersonal Affectivity Scale),
perceived burden (Burden Assessment Scale), time spent in caregiving activities and
caregiving expenses (Family Resources Interview), knowledge about schizophrenia and
cognitive deficits (Modified Schizophrenia Knowledge Scale), caregiving self-efficacy
(Family Self-Efficacy Scale), positive aspects of caregiving (Gratifications and Benefits of
Caregiving Questionnaire) and psychological distress (Beck Anxiety and Depression Scales).
In addition, relatives will be asked to provide collateral information about the client's
adaptive living skills (using the "Informant Version" of the Independent Living Skills
Survey and the Independent Living and Self-Care Skills Checklist) and cognitive functioning
(Clinical Global Impression of Cognition in Schizophrenia, Frontal Lobe Personality
Scale—Family Version).
Additional measures.
Clients and relatives will complete an adapted measure of satisfaction with the program
(Satisfaction Questionnaire) and will be asked to report which aspects of it they found most
helpful and whether they were able to practice skills introduced. Therapist time spent
delivering the intervention will be recorded on a weekly basis. Notes for each session will
be recorded on a "Contact Summary" form. Interest in the program will be measured by keeping
track of the number of referrals to the program compared to the number of families who
participate. In addition, we will document rates of attendance.
Participants will be assessed at baseline, post-intervention, and 3- and 6-months following
completion of the the intervention. A total of 20 clients diagnosed with schizophrenia,
schizoaffective disorder, or schizophreniform disorder and their families will be recruited
from the Massachusetts General Hospital Freedom Trail Clinic and the Beth Israel Deaconess
Medical Center (including,the Massachusetts Mental Health Center and the BIDMC inpatient and
outpatient departments). Clients and their families will participate in the Family-Directed
Cognitive Adaptation (FCA) intervention, including a functional assessment, 16 single-family
sessions and 6 sessions of a monthly, multiple-family group. Follow-up assessments will be
conducted by a clinical evaluator (who is not directly involved in the treatment) at the end
of the individual-family treatment and at about 3 and 6 months following completion of
treatment on all clients and relatives on a variety of outcome measures specified below
(timing of assessments may occasionally be delayed by about 1-4 weeks in order to
accommodate the schedules of clients and families). Sessions will be audiotaped for use in
the development of an instrument for measuring therapist fidelity to the treatment model.
Treatment Program.
The FCA program is designed to teach clients and families about neurocognitive deficits
associated with schizophrenia, recommend specific compensatory strategies and positive
behavioral supports for managing these deficits, and teach families to help the client to
implement these strategies in order to improve adaptive living skills. The FCA program will
begin with a comprehensive cognitive and functional assessment of the client and the home
environment in order to identify specific functional targets for the intervention. This will
include: 1) a neuropsychological assessment of attention, processing speed, memory and
executive functioning; 2) an assessment of independent living skills (e.g., time management,
grooming, self-care); and 3) a home assessment to identify barriers to adaptive functioning
in the client's home environment. Specific measures are described below and attached in the
Appendix.
Following the cognitive and functional assessments, clients and their relatives will receive
16 individual-family sessions (14 weekly sessions and 2 bi-weekly sessions—However, timing
of sessions may vary a bit to accommodate schedules of participants. We will aim to complete
the counseling sessions within 18-22 weeks), and 6 sessions of a monthly, multifamily group
(3-4 sessions will be concurrent with individual sessions, and 2-3 sessions will serve as
maintenance groups following the completion of the main, individual-family intervention).
The individual sessions in the FCA program will include: 1) general psychoeducation about
illness symptoms and cognitive deficits associated with schizophrenia (about 4 sessions), 2)
a feedback session presenting the results of the cognitive and functional assessment, and
identification of functional targets for the intervention, and 3) completion of 2-3 modules
targeting specific deficits in adaptive functioning that were identified during the
evaluation. Most sessions will be conducted at the clinic where the client receives
psychiatric treatment, but 3-4 home visits will also be conducted to facilitate modification
of the home environment and generalization of compensatory skills. Sessions will include the
client and at least one family member who lives with the client. The principal investigator
will serve as a clinician for this program along with a co-leader, and they will serve as
members of the client's clinical team.
Data to Be Recorded (Measures).
Clients and participating relatives will be assessed by a clinical evaluator (who is not
directly involved in the treatment) via structured interviews and self-report instruments at
four time points, including baseline, completion of the individual-family intervention, and
at about 3 and 6 months following completion of the intervention. (Timing of assessments may
vary a bit to accommodate schedules of participants. Therefore, follow-up one will take
place within 2 weeks after ending the 16 session program, follow-up two will take place
12-14 weeks, and follow-up three will take place between 12-14 weeks after the third
follow-up.)
Client measures.
Baseline measures will include an assessment of psychiatric diagnosis (SCID, chart review,
and collateral information gathered from the client's treating clinician and relatives) and
general demographic information. Clients will also undergo a neuropsychological evaluation
at baseline. This evaluation will consist of the MATRICS Provisional Consensus Cognitive
Battery Phase II. A brief selection of measures from this battery will be repeated at the
post-intervention assessment. Detailed descriptions of measures and copies of measures are
included in the Appendix.
Assessments at all time points (baseline, post-intervention, 3- and 6-month follow-up) will
include measures of symptoms (Brief Psychiatric Rating Scale, Scale for the Assessment of
Negative Symptoms, Positive and Negative Syndrome Scale), adaptive living skills and
functioning (Social Adaptive Functions Scale, Independent Living Skills Survey, Multnomah
Community Ability Scale, The Independent Living and Self-Care Skills Checklist, and the
Global Assessment of Functioning), behaviors related to cognitive functioning (Clinical
Global Impression of Cognition in Schizophrenia, Frontal Lobe Personality Scale—Patient
Version), and the degree to which the patient perceives their relatives as critical of them
(Interpersonal Affectivity Scale). Furthermore, chart reviews will be conducted to record
any inpatient hospitalizations that occur during the study period and number of days spent
in the hospital.
Family member measures. Baseline measures will include general demographic information (age,
ethnicity, level of education, etc). All assessments will include measures of negative
attitudes towards the client (Patient Rejection Scale, Interpersonal Affectivity Scale),
perceived burden (Burden Assessment Scale), time spent in caregiving activities and
caregiving expenses (Family Resources Interview), knowledge about schizophrenia and
cognitive deficits (Modified Schizophrenia Knowledge Scale), caregiving self-efficacy
(Family Self-Efficacy Scale), positive aspects of caregiving (Gratifications and Benefits of
Caregiving Questionnaire) and psychological distress (Beck Anxiety and Depression Scales).
In addition, relatives will be asked to provide collateral information about the client's
adaptive living skills (using the "Informant Version" of the Independent Living Skills
Survey and the Independent Living and Self-Care Skills Checklist) and cognitive functioning
(Clinical Global Impression of Cognition in Schizophrenia, Frontal Lobe Personality
Scale—Family Version).
Additional measures.
Clients and relatives will complete an adapted measure of satisfaction with the program
(Satisfaction Questionnaire) and will be asked to report which aspects of it they found most
helpful and whether they were able to practice skills introduced. Therapist time spent
delivering the intervention will be recorded on a weekly basis. Notes for each session will
be recorded on a "Contact Summary" form. Interest in the program will be measured by keeping
track of the number of referrals to the program compared to the number of families who
participate. In addition, we will document rates of attendance.
Inclusion Criteria:
1. Age 18 or older,
2. fluent in English.
3. Primary DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, or
schizophreniform disorder. Diagnoses will be confirmed by review of client's records
and prior structured research interview and/or the Structured Clinical Interview for
the DSM-IV (SCID).
4. Lives with at least one family member or long-term partner (> 1 year).
5. Voluntary informed consent for participation in the study by the participant (or by
the participant's legally designated guardian) and the participant's family member.
Exclusion Criteria:
1. Diagnosis of dementia, neurodegenerative disease, pervasive developmental disorder,
or other neurological disorder such as a serious traumatic brain injury that produces
significant cognitive impairments.
2. Individuals diagnosed with psychotic disorders due to a general medical condition or
substance-induced psychotic disorders.
3. Substance abuse (to substances other than nicotine) in past three months or
dependence in the past year.
4. Patients who, in the investigator's clinical opinion and based on evaluation, pose a
current homicide or suicide risk.
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