Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Harvard University
Commonwealth Research Center, Massachusetts
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00434980
First received: February 12, 2007
Last updated: February 13, 2007
Last verified: February 2007
  Purpose

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.

Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Behavioral: Family-Directed Cognitive Adaptation Program
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Feasibility of a Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • All of the following are measured at baseline, post-intervention,
  • and 3 and 6-month follow up
  • Social Adaptive Functions Scale (P)
  • Multnomah Community Ability Scale (P)
  • Global Assessment of Functioning (P)
  • F= Family measure P= Patient measure

Secondary Outcome Measures:
  • All of the following are measured at baseline, post-intervention,
  • and 3 and 6-month follow up
  • BPRS, PANSS (P)
  • SANS (P)
  • Interpersonal Affectivity Scale (P, F)
  • Knowledge Questionnaire (P, F)
  • Independent Living Skills Survey (P, F)
  • Ind Living Self Care Checklist (P, F)
  • Frontal Lobe Personality Scale (P, F)
  • Clinical Global Impression of Cognition in Schizophrenia (P, F)
  • Patient Rejection Scale (F)
  • Modified Family Resources Interview (F)
  • Modified Schizophrenia Knowledge Scale (F)
  • Family Self-Efficacy Scale (F)
  • Caregiving Gains and Benefits/ Gratifications Module (F)
  • Beck Depression and Anxiety Inventories (F)
  • This measure is completed post-intervention only:
  • Client Satisfaction Questionnaire (P, F)
  • F= Family measure P= Patient measure

Estimated Enrollment: 20
Study Start Date: February 2005
  Hide Detailed Description

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434980

Contacts
Contact: Michelle S. Friedman-Yakoobian, Ph.D. 617-626-9357 mfriedmanyakoobian@partners.org

Locations
United States, Massachusetts
Freedom Trail Clinic Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Michelle S. Friedman-Yakoobian, Ph.D.         
Massachusetts Mental Health Center Recruiting
Jamaica Plain, Massachusetts, United States, 02130
Principal Investigator: Michelle S. Friedman-Yakoobian, Ph.D.         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Harvard University
Commonwealth Research Center, Massachusetts
Investigators
Study Chair: Larry J. Seidman, Ph.D. Beth Israel Deaconess Medical Center
Principal Investigator: Michelle S. Friedman-Yakoobian, Ph.D. Beth Israel Deaconess Medical Center / Massachusetts General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00434980     History of Changes
Other Study ID Numbers: 2005P-000383
Study First Received: February 12, 2007
Last Updated: February 13, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Cognitive adaption
Schizophrenia
Cognitive rehabilitation
Family treatment
Cognitive deficits
Serious mental illness

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014