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Clinical Trials/NCT00434980
NCT00434980CompletedNot Applicable

Pilot Study of the Feasibility of a Family-Directed Cognitive Adaptation Program for Individuals With Schizophrenia

Beth Israel Deaconess Medical Center2 sites in 1 country11 target enrollmentStarted: February 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
2
Primary Endpoint
Brief Psychiatric Rating Scale, Positive and Negative syndrome Scale, Scale for the Assessment of Negative symptoms

Study Overview

Brief Summary

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.

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 (BIDMC) (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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 18 or older,
  • •fluent in English.
  • •Primary Diagnostic and Statistical Manual of Mental Disorders 4th edition (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).
  • •Lives with at least one family member or long-term partner (> 1 year).
  • •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

  • •Diagnosis of dementia, neurodegenerative disease, pervasive developmental disorder, or other neurological disorder such as a serious traumatic brain injury that produces significant cognitive impairments.
  • •Individuals diagnosed with psychotic disorders due to a general medical condition or substance-induced psychotic disorders.
  • •Substance abuse (to substances other than nicotine) in past three months or dependence in the past year.
  • •Patients who, in the investigator's clinical opinion and based on evaluation, pose a current homicide or suicide risk.

Arms & Interventions

Treatment

Experimental

Participant and family take part in FCA treatment program.

Intervention: Family-Directed Cognitive Adaptation Program (Behavioral)

Outcomes

Primary Outcomes

Brief Psychiatric Rating Scale, Positive and Negative syndrome Scale, Scale for the Assessment of Negative symptoms

Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

Social Adaptive Functions Scale (P)

Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

Multnomah Community Ability Scale (P)

Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

Global Assessment of Functioning (P)

Time Frame: Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment

Secondary Outcomes

  • Modified Family Resources Interview (F)(Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment)
  • Family Self-Efficacy Scale (F)(Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment)
  • Caregiving Gains and Benefits/ Gratifications Module (F)(Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment)
  • Interpersonal Affectivity Scale (P, F); Knowledge Questionnaire (P, F), Independent Living Skills Survey (P, F),Ind Living Self Care Checklist (P, F(Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment)
  • Clinical Global Impression of Cognition in Schizophrenia (P, F)(Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment)
  • Patient Rejection Scale (F)(Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment)
  • Beck Depression and Anxiety Inventories (F)(Baseline, end of treatment, and 3 months after end of treatment, 6 months after end of treatment)
  • Client Satisfaction Questionnaire (P, F)(end of treatment, and 3 months after end of treatment, 6 months after end of treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michelle Friedman-Yakobian

Instructor in Psychology in the Department of Psychiatry

Beth Israel Deaconess Medical Center

Study Sites (2)

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