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

NCT00455663 | Completed Results DMC

• 2 other identifiers: R01MH062850DAHBR 96-BHA
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizoaffective Disorder; Medication Adherence

Outcome Measures

Primary Outcomes (4)

• Medication Adherence-pill Count

  % 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.

  1 final score combined for endpoint for 9 months of treatment and 6 months follow up

• Positive Symptoms

  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.

  1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up

• Social and Occupational Functioning Scale Score

  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.

  1 endpoint ls means combining 9 months of treatment and 6 months follow up

• Number of Patients Surviving Without Relapse/Exacerbation

  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

  9 months of treatment 6 months follow up

Study Arms (3)

Cognitive Adaptation Training

EXPERIMENTAL

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

Pharm-Cognitive Adaptation Training

EXPERIMENTAL

Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.

Behavioral: Pharm-Cognitive Adaptation Training

Treatment As Usual

ACTIVE COMPARATOR

Medication follow up and limited case management provided by local mental health authority

Other: Treatment as usual

Interventions

Cognitive Adaptation Training BEHAVIORAL

Environmental supports for all independent living skills

Cognitive Adaptation Training

Pharm-Cognitive Adaptation Training BEHAVIORAL

Environmental supports for medication and appointment adherence

Pharm-Cognitive Adaptation Training

Treatment as usual OTHER

Medication follow-up and limited case management provided by local community mental health authority

Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Texas Health Science Center

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Medication Adherence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Subjects were ill for a long-period of time

Results Point of Contact

• Title: Dawn I. Velligan
• Organization: UTHSCSA

velligand@uthscsa.edu

210-567-5508

Study Officials

• Dawn I. Velligan, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry

Study Record Dates

• First Submitted: April 2, 2007
• First Posted: April 4, 2007
• Study Start: November 1, 2000
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: June 15, 2015
• Results First Posted: June 15, 2015

Record last verified: 2015-05

Locations

US (1)