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SchizophreniaNCT00980252

Medication Adherence in Schizophrenia: Development of a CBT-Based Intervention

A study testing Cognitive Behavioral Therapy in people with Schizophrenia and Psychotic Disorders, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized pilot study of an intervention based on principles of Cognitive Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and will be compared to a traditional medical model of psychoeducation known as Team Solutions (TS) for first-episode schizophrenia patients. Read more about this study

Who is it for?
Ages 16 to 45 years
Conditions the study is for
Schizophrenia, Psychotic Disorders
What is being tested?
Cognitive Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
Nov 2009to Mar 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Between 16-45 years of age
  • A provisional clinical diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder in last 6 months
  • Discharge from inpatient unit for treatment of psychotic symptoms must have occurred in the last 6 months, or, if never hospitalized, initial treatment started in the last 6 months
  • Able to fully participate in the informed consent process
  • The patient is judged to be an appropriate candidate for ongoing outpatient follow-up at the First-episode Treatment Program at the Psychotic Disorders Program at UIC
  • Willingness to transition to receive evaluation and future pharmacologic treatment at the Psychotic Disorders Program at UIC
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  • Has capacity to understand the risks and benefits of participating in a randomized psychosocial trial
  • Willingness to sign informed consent to go into the Treatment Intervention Phase
  • Is able to complete a post-test for understanding the nature of the study and what it entails, and the potential risks and benefits of study participation
  • Is willing to have therapy sessions recorded for fidelity assessments
  • Is willing to receive follow-up independent assessments of adherence status, including separate interviews with trained independent raters, and our contacting the outpatient pharmacy for pharmacy refill records

Who cannot join

  • Unable to understand informed consent process
  • A history of nonresponse to prior antipsychotic trials such that long-term inpatient treatment or clozapine will be recommended
  • Prior treatment with clozapine
  • Discharge from inpatient treatment for psychotic symptoms, initial treatment, or provisional diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform occurred more than 6 months from enrollment into the evaluation phase
  • Pregnancy or stated goal to become pregnant
  • Will not be living close enough to the medical center to return for follow-up visits or assessments
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  • History of geographic instability such that it is judged unlikely that patient will reside in the area
  • Currently under arrest for a felony, or an arrest is deemed likely in the near future
  • Currently receiving medication over objection by court order
  • Currently receiving treatment in another research protocol
  • Diagnosis or inpatient treatment for psychotic symptoms occurred more than 6 months from date of enrollment into evaluation phase
  • Acutely psychotic individuals may not participate because therapy will not benefit if symptoms are too severe
  • Has dropped out of the treatment program and cannot be located for follow-up appointments
  • Stated refusal to come for to at least one clinical evaluation appointment at the PDP, or has been a "no show" for at least three consecutive appointments
  • Judged to be at significant and imminent risk of harm to self or others*
  • Ongoing active substance or alcohol use that is not controlled during the Evaluation Phase, along with refusal of referral to a "dual diagnosis" treatment program for substance abuse problems
  • Remains enrolled in another research protocol at UIC*
  • Unwilling to consider any additional psychotherapeutic intervention above and beyond coming in to the service for medication management appointment
  • Baseline PANSS total score ≥ 90, or has a individual PANSS item of conceptual disorganization (item P2), excitement (P4), or hostility (P7) that is ≥ 5 (moderately severe)*
  • Judged to require additional concrete case management services to support medication adherence*
  • Receives antipsychotics under coercive conditions (e.g. inpatient or outpatient commitment)*
  • Note: The exclusion criteria () may be present during some parts of the Evaluation Phase and would need to be resolved within the 4 week time period permitted for the Evaluation Phase prior to the Treatment Intervention Phase of study entry.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

Other trials in United States

About this study

This is a randomized pilot study of an intervention based on principles of Cognitive Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and will be compared to a traditional medical model of psychoeducation known as Team Solutions (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS, compare adherence attitudes at the end of the treatment intervention, and to compare the time until the first episode of nonadherence.

Read the detailed description

Overview: Many people recovering from first-episode schizophrenia typically respond very well to their initial course of antipsychotic medications; however, studies indicate that nonadherence rates soar as high as 90% in the first year and do not improve over time. To date, there is no effective psychosocial intervention that improves adherence or reduces the adverse consequences of nonadherence after it occurs. Thus, it is imperative to develop a new intervention to improve medication adherence and improve clinical outcomes in patients recovering from first-episode schizophrenia.

This study is to pilot an intervention specifically suited for patients with first-episode schizophrenia based on the principles of Cognitive Behavioral Therapy (CBT). This is to focus on adherence from the perspective of the patient.

Methods: This study compares the effectiveness of a standard psychoeducation program [Team Solutions (TS)] to a CBT approach known as the Health Dialogue Intervention (HDI). Consenting patients will receive a 4 week stabilization assessment period and then be randomized to a prospective, random-assignment study comparing the effectiveness of TS to HDI to improve medication adherence of patients recovering from first-episode schizophrenia.

Keywords
Schizophrenia, Cognitive Behavioral Therapy, Compliance, Medication Adherence, Psychotic Disorders, Mental Disorders, Outcomes, Psychoeducation, Adherence Attitudes, Intervention, Nonadherence, Schizophrenia and Disorders with Psychotic Features
Medical subject headings
Schizophrenia, Psychotic Disorders, Patient Compliance, Medication Adherence, Mental Disorders, Schizophrenia Spectrum and Other Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00980252
Study groupRoleWhat they receive
CBTExperimentalUK-based intervention
Receives: Behavioral: Cognitive Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. Acceptance of therapeutic intervention as measured by number of sessions attended. 2. Difference in adherence behavior as measured by duration of antipsychotic treatment during follow up (ASV). 3. Differences in adherence attitudes (ROMI).

    Measured: Completion of Study

Secondary outcomes (1)

  1. 1. Compare the course of symptoms and relapse of patients in HDI to those in the TS.

    Measured: Completion of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2012
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00980252
Sponsor's protocol ID
R34MH080978
Other IDs
R34MH080978, R34MH080978-01A2, DSIR 83-AT
Status last verified
Jun 2014
First submitted
18 Sep 2009
Last updated
16 Jun 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy in people with Schizophrenia and Psychotic Disorders, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Acceptance of therapeutic intervention as measured by number of sessions attended. 2. Difference in adherence behavior as measured by duration of antipsychotic treatment during follow up (ASV). 3. Differences in adherence attitudes (ROMI). (time frame: Completion of Study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00980252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014.

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Clinical Trial NCT00980252 | AzTrials