Increasing Medication Check Participation Through Applying CT-r

NCT06231407 | Completed

• 1 other identifier: 220048
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this feasibility and acceptability trial is to learn about the acceptability of adding a recovery-oriented, psychological framework to a standard medication management appointment with a psychiatrist and any impact on attendance and functioning. The main question\[s\] it aims to answer are:

1. 1.Will CT-R medication checks will be acceptable to the patient and feasible to deliver and receive, as measured by asking patients how they like the CT-R med checks and our ability to do this study in addition to number of patient drop-outs?
2. 2.Will CT-R medication checks will be related to significantly greater engagement with treatment as measured by: lower no-show rates, greater self-reported working alliance, and better treatment adherence?
3. 3.Will CT-R medication checks will be related to greater activity and increase in functioning as measured by: time use survey, GAF, skill use?
4. 4.Will CT-R medication checks will be related to a trend in improved defeatist beliefs, negative symptoms, paranoia, and self-esteem?

Conditions

Schizophrenia and Related Disorders

Keywords

Schizophrenia Spectrum Diagnosis; Cognitive Therapy; Cognitive Behavioral Therapy for Psychosis (CBTp); Recovery-Oriented Cognitive Behavioral Therapy for Psychosis; CT-R; Medication Management Appointments

Outcome Measures

Primary Outcomes (4)

• Working Alliance Inventory

  Measure of patient perception of working alliance

  Upon Enrollment in the study, Up to 4 months later, At study completion (average of 1 year)

• Time Use Interview

  Interview capturing amount of time in productive activity.

  Upon Enrollment in the study, Up to 4 months later, At study completion (average of 1 year)

• Mental Illness Research Education and Clinical Center (MIRECC) Global Assessment of Functioning (GAF)

  Standardized Measure of overall functioning; Scored from 0-100 with higher score indicating better functioning. Scoring is based on predetermined parameters.

  Upon Enrollment in the study, Up to 4 months later, At study completion (average of 1 year)

• Compass

  Interview of symptoms and their severity.

  Upon Enrollment in the study, Up to 4 months later, At study completion (average of 1 year)

Secondary Outcomes (7)

• Defeatist Beliefs Scale

  Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months)

• Asocial Beliefs Scale

  Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months)

• Cognitive Insight Scale

  Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months)

• Green Paranoid Thoughts Scale

  Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months)

• Self Esteem Scale

  Upon Enrollment in the Study, on average the first of the month until the final assessment (approximately 15 months)

Study Arms (2)

Recovery Oriented CBTp Med Check

EXPERIMENTAL

Resident physicians will provide medication appointments, supervised by their attending physician (Stovall) and CT-R supervisor (Brinen). They will conduct their appointment per protocol detailed in a treatment manual. No additional/special information needs to be recorded in medical record, beyond the clinical notes expected per VAPOC policy. Appointments will be a standard length.

Behavioral: Recovery Oriented CBTp Medication Management

Treatment as Usual

ACTIVE COMPARATOR

Patient will attend traditional medication management check appointments with psychiatry residents.

Behavioral: Treatment as Usual

Interventions

Recovery Oriented CBTp Medication Management BEHAVIORAL

The prescriber structures the medication appointment to elicit and focus on subjects long term, valued goals (aspirations). With this information the prescriber will develop a plan to increase daily activity to facilitate the aspiration's pursuit. Obstacles (psychotic symptoms, motivational problems) will be identified and a formulation developed with the individual. Psychosocial interventions will be implemented for the various obstacles alongside monitoring and implementing of medications. Across sessions, the prescriber will continue to implement and monitor psychosocial interventions.

Also known as: Recovery Oriented Cognitive Therapy

Recovery Oriented CBTp Med Check

Treatment as Usual BEHAVIORAL

Residents will conduct medication management appointments as normally conducted

Also known as: TAU

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Schizophrenia-spectrum disorder
• Typically scheduled 1x/month
• Willingness to complete 2-3 hours of testing at multiple timepoints
• Likely to stay in our clinic for the next 1-2 years

You may not qualify if:

• Significant intellectual disability
• Autism spectrum disorder
• Cannot read/write English

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Grant PM, Huh GA, Perivoliotis D, Stolar NM, Beck AT. Randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia. Arch Gen Psychiatry. 2012 Feb;69(2):121-7. doi: 10.1001/archgenpsychiatry.2011.129. Epub 2011 Oct 3.

  PMID: 21969420 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry and Behavioral Sciences

Model Details: Subjects were recruited from an existing psychosis clinic and assigned to the participating psychiatry resident. A small group were misaligned and reconnected to use their data as a comparison for someone not receiving the intervention.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: January 30, 2024
• Study Start: March 17, 2022
• Primary Completion: June 13, 2023
• Study Completion: December 6, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

US (1)