Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dawn Velligan, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00455663
First received: April 2, 2007
Last updated: May 29, 2015
Last verified: May 2015
  Purpose

This study will compare the effectiveness of three treatments in improving medication adherence, symptoms, and function in people with schizophrenia.


Condition Intervention
Schizophrenia
Behavioral: Cognitive Adaptation Training
Behavioral: Pharm-Cognitive Adaptation Training
Other: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medication Adherence and Outcomes in Schizophrenia

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Medication Adherence-pill Count [ Time Frame: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up ] [ Designated as safety issue: No ]
    % medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

  • Positive Symptoms [ Time Frame: 1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up ] [ Designated as safety issue: No ]
    Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

  • Social and Occupational Functioning Scale Score [ Time Frame: 1 endpoint ls means combining 9 months of treatment and 6 months follow up ] [ Designated as safety issue: No ]
    Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

  • Number of Patients Surviving Without Relapse/Exacerbation [ Time Frame: 9 months of treatment 6 months follow up ] [ Designated as safety issue: No ]
    A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision


Enrollment: 105
Study Start Date: November 2000
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Adaptation Training
In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
Behavioral: Cognitive Adaptation Training
Environmental supports for all independent living skills
Experimental: Pharm-Cognitive Adaptation Training
Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
Behavioral: Pharm-Cognitive Adaptation Training
Environmental supports for medication and appointment adherence
Active Comparator: Treatment As Usual
Medication follow up and limited case management provided by local mental health authority
Other: Treatment as usual
Medication follow-up and limited case management provided by local community mental health authority

Detailed Description:

Schizophrenia is a chronic and severely disabling mental disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. Antipsychotic medications have been effective in alleviating many of the symptoms of schizophrenia and improving the lives of people with the disease. It is well established, however, that poor adherence to antipsychotic medications can lead to relapse and rehospitalization. Cognitive deficits often contribute to treatment nonadherence by compromising patients' capacity to establish routines for taking medication. Cognitive adaptation training (CAT) is a treatment approach designed to alter the physical environment of individuals with schizophrenia to compensate for cognitive deficits and improve adaptive function. For example, various environmental supports, such as signs, checklists, and electronic devices, are used to remind patients to take their medication. Studies have shown that CAT's support system led to better treatment outcomes than those produced by standard care in people with schizophrenia. This study will compare the effectiveness of two CAT treatments versus standard treatment in improving medication adherence, symptoms, and function in people with schizophrenia.

After providing a blood sample, participants in this single-blind study will be randomly assigned to Full-CAT, Pharm-CAT, or treatment as usual for 9 months. Participants receiving treatment as usual will not receive CAT support. Full-CAT will entail a comprehensive use of environmental supports to improve multiple areas of adaptive functioning. Pharm-CAT will provide support for medication adherence only. Participants assigned to one of the two CAT groups will receive weekly treatments in their homes. All participants will report to the study site once every 3 months to assess medication adherence, symptomatology, and adaptive functioning. Participants will be interviewed by the study physician for 2 to 3 hours at each visit. A member of the study staff will also visit each participant's home at a random, unannounced time once every 3 months to obtain a blood sample. Follow-up visits will occur 3 and 6 months following the end of treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • If entering the study as an inpatient, hospitalization was recent
  • Currently receiving treatment with an atypical antipsychotic and continuation on the medication has been recommended
  • Assumes primary responsibility for taking medication
  • Currently living in a stable environment

Exclusion Criteria:

  • History of significant head trauma, seizure disorder, or mental retardation
  • History of alcohol or drug abuse or dependence within 1 month prior to study entry
  • History of violence within 6 months prior to study entry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455663

Locations
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Dawn I. Velligan, PhD University of Texas
  More Information

No publications provided

Responsible Party: Dawn Velligan, Professor, Psychiatry, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00455663     History of Changes
Other Study ID Numbers: R01 MH62850, R01MH062850, DAHBR 96-BHA
Study First Received: April 2, 2007
Results First Received: August 8, 2013
Last Updated: May 29, 2015
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center at San Antonio:
Schizoaffective Disorder
Medication Adherence

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

ClinicalTrials.gov processed this record on July 30, 2015