Increasing Medication Check Participation Through Applying CT-r
Condition: Schizophrenia and Related Disorders
MeSH terms: Schizophrenia
Study type: Interventional

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. 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. 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. 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. Will CT-R medication checks will be related to a trend in improved defeatist beliefs,
           negative symptoms, paranoia, and self-esteem?

      Researchers will compare the group assigned to the trial psychiatrists to a small group who
      were assigned to non-trial psychiatrists to see if the intervention impacted any of the above
      questions beyond TAU.
    

Detailed description: 
      The current study aims to test whether adapting a psychological treatment for schizophrenia
      to medication appointments with psychiatry residents is acceptable and feasible, and whether
      it improves treatment engagement, functioning and symptom burden, particularly negative
      symptoms. In addition to providing psychiatry residents with a framework for conducting
      medication appointments, it will also give patients with psychotic disorders access to
      empirically-supported psychological interventions, that they may not otherwise have access
      to. We will test the acceptability and feasibility of this adapted intervention and examine
      whether effect sizes of change with intervention in this sample size warrant testing in a
      larger study.

      Only patients who consent to being in the study will receive CT-R medication appointments.
      CT-R is a therapy process that is being implemented within the medication appointments. The
      provided measures and tasks are outcomes to be measured throughout the study. For instance,
      we are interested in how clinical symptoms, subjective well-being, and treatment engagement
      change with the implementation of CT-R in medication appointments.

        1. 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. 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. CT-R medication checks will be related to greater activity and increase in functioning
           as measured by: time use survey, GAF, skill use

        4. CT-R medication checks will be related to a trend in improved defeatist beliefs,
           negative symptoms, paranoia, and self-esteem

        5. Exploratory analyses will include:

             1. CT-R med checks will be related to greater improvement on a cognitive motivation
                task (EEfRT/Balloon task)

             2. Improvement in Defeatist Belief Scale (DBS) and Neg Symptoms will be mediated by
                increased treatment adherence, engagement and activity

      Expected study duration: 3 years

      3. Procedures_________________________________________________________________

      4.1 Recruitment Vanderbilt Adult Psychiatry Outpatient Clinic (VAPOC): Individuals who are
      currently being seen for medication management through VAPOC, and who meet eligibility
      criteria, will be identified by the treating providers and study staff through review of
      medical records and consultation with providing clinicians. Potential participants will only
      be approached with the approval of the treating provider, who will determine whether that
      individual is likely to have the capacity to consider the research study and provide consent.
      If appropriate, their provider will ensure that the patient is agreeable to being approached
      about a research study or introduce the patient to the research team. Potential participants
      will be approached by research staff after their appointment for a brief screening visit.

      Recruitment may occur in person, over telehealth, or over the phone. VAPOC accommodates both
      in-person and telehealth appointments, depending on the patient's preference. Therefore, for
      eligible patients who are seen regularly over telehealth, recruitment may occur by joining
      the telehealth appointment at the end of the visit. Additionally, potential participants may
      not be available to stay after their appointment, despite interest in the study. Therefore,
      individuals identified as a good fit, who cannot be connected with in-person, will be called
      on the phone for a screening, with the provider's consent and after the provider has ensured
      that the patient is agreeable to being called about a research study.

      Resident subjects will be recruited from Vanderbilt Adult Psychiatry Outpatient Clinic.
      Residents who are involved with the study will be contacted either by email or in-person to
      assess their interest in being enrolled and consented as a participant in order for the
      research team to gather information about the acceptability and feasibility of carrying out
      the intervention.

      4.3 Planned enrollment: We plan to recruit up to 40 subjects for the study.

      4.4 Screening and Consent: Potential research subjects will be asked if they would like to
      participate in the current study. If they report potential interest, a pre-screening will
      occur. This screening will occur in person, over the phone or over telehealth (Zoom) using
      the Screening Form or Phone Script. Informed consent will be obtained by study personnel
      directly involved in the research (i.e. research staff or PI). Personnel have completed IRB
      training and have considerable experience running studies in clinical populations.

      Informed consent will be obtained either, 1) in the research offices at the Psychiatric
      Neuroimaging Program or 2) over Zoom during a virtual study visit. A research staff member
      will explain the applicable procedures and the possible risks and benefits to the subjects.
      The details of the informed consent procedure are as follows:

        1. The investigator or research staff and the subject will read together the entire consent
           form.

        2. The subject will be asked details about the study. To document that the subject has read
           the consent form and has the capacity to understand the most important details, the
           investigator will use the appropriate Informed Consent Survey. The questions will be
           read by the investigator or research staff and the answers will be recorded. If the
           subject is unable to answer any of the questions, or if the subject demonstrates a lack
           of understanding, the investigator or research staff member will then review the details
           of the study again. Subjects who are unable to answer the questions, even after
           additional information is provided, will be excluded from the study.

        3. The subject will be informed that regardless of whether or not they take part in this
           research study, it will not affect their treatment, payment or enrollment in any health
           plans or affect their ability to get benefits or care in any way.

        4. The subject will be provided with copies of the signed consent form and the Informed
           Consent Survey (including the answers given) at the time of the initial visit. If
           completed virtually, this will be emailed, using secure email methods, to the subject
           with their consent.

        5. At each visit, we will 1) remind participants that the research visit is voluntary (no
           matter how many previous visits they have done) and 2) ask them to tell us what they
           believe the purpose of the study is and repeat back what they will be doing that day
           (e.g. cognitive tasks, self-reports).

      It will be emphasized to all subjects that their participation is completely voluntary, and
      that even after signing the consent document they are still free to withdraw from the study
      at any time. It will also be emphasized that if they choose to leave the study, their
      medication management at VAPOC will not be impacted, and they can continue seeing their
      medication provider as usual.

      4.5 Intervention Assignment

      Participants will not be randomized. Instead, they will serve as their own controls.
      Individuals will be recruited during Spring 2022 as described in section 3.1. Following their
      baseline assessment, participants will continue treatment as usual (TAU) with their current
      provider. The amount of time they are in the TAU branch of the study will depend on their
      date of recruitment. The intervention phase of the study will occur between August 2022- June
      2023, after the patient has established care with their new provider. Therefore, a
      participant who was recruited in April 2021 may have a TAU duration of 5 months, whereas a
      participant who was recruited in June 2021 may only have TAU of 2 months. Participants not
      assigned to a resident associated with the study will continue in the study as controls,
      given their re-consent.

      4.7 Medication appointments

      Resident physicians will provide medication appointments, supervised by their attending
      physician (Stovall) and CT-R supervisor (Brinen). They will conduct their appointment per
      protocol (see below). 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.

      No-shows and hospitalizations will be recorded in the chart per clinic procedures and will be
      monitored and recorded by study staff, with additional support from the Informatics team.

      4.8 Video/Audio Recording

      In order to ensure treatment fidelity, medication appointments will be video and/or audio
      recorded. Further, the qualitative interviews will be audio-recorded for later analyses. All
      recordings will be included in the Informed Consent document and described to the
      participants prior to study enrollment. Physicians will upload their sessions to a folder on
      Vanderbilt University Medical Center (VUMC) Box, which will only be available to necessary
      study staff for review. Additionally, qualitative interview recordings will be uploaded to a
      folder on VUMC Box, which will only be available to necessary study staff for review.
    

Intervention name(s): Recovery Oriented CBTp Medication Management; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Residents will conduct medication management appointments as normally conducted
Other intervention name(s): Recovery Oriented Cognitive Therapy; TAU
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia Spectrum Diagnosis; Cognitive Therapy; Cognitive Behavioral Therapy for Psychosis (CBTp); Recovery-Oriented Cognitive Behavioral Therapy for Psychosis; CT-R; Medication Management Appointments