Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia
|ClinicalTrials.gov Identifier: NCT00455663|
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : June 15, 2015
Last Update Posted : June 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Cognitive Adaptation Training Behavioral: Pharm-Cognitive Adaptation Training Other: Treatment as usual||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Medication Adherence and Outcomes in Schizophrenia|
|Study Start Date :||November 2000|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
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
- Medication Adherence-pill Count [ Time Frame: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up ]% 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 ]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 ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455663
|United States, Texas|
|University of Texas Health Science Center|
|San Antonio, Texas, United States, 78229-3900|
|Principal Investigator:||Dawn I. Velligan, PhD||University of Texas|