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Decision-making and Decision Support Among Emerging Adults With First Episode Psychosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04373590
Recruitment Status : Completed
First Posted : May 4, 2020
Last Update Posted : February 15, 2021
Information provided by (Responsible Party):
Yaara Zisman Ilani, Temple University

Brief Summary:
The purpose of this study is to evaluate the impact of an antipsychotic medication decision aid and interpersonal and cognitive factors, such as attachment style and motivation, on emerging adults' ability to engage in shared decision making regarding their medications.

Condition or disease Intervention/treatment Phase
Early Psychosis Behavioral: Decision aid Not Applicable

Detailed Description:

The long-term occupational, social, and economic outcomes associated with psychosis make it an urgent public health problem. Coordinated specialty care (CSC) is now the gold standard for early psychosis, demonstrating positive clinical and functional effects in the short-term, and longer-term reduced hospitalization rates. These services include an array of treatment options, including psychotropic medications, individual psychotherapy, family education, and support, and occupational therapy and supported employment/education.

While a shorter period between psychosis onset and receipt of appropriate care is associated with better outcomes, emerging adults often experience significant delays before receiving treatment, and a large percentage disengage from services once they are commenced. Decisional conflict about treatment options (i.e., feeling conflicted about which option to choose) and interpersonal factors such as attachment style and trust in health providers can contribute to decision delay and discontinuance of chosen options. Decision support tools (e.g., decision aids), have been shown to reduce decisional conflict as well as improve service engagement. A requisite step in expanding the array of decision support tools available to emerging adults experiencing early psychosis is to better understand their decision-making ability, capacity, and motivation to engage in decision making and how these relate to their engagement in CSC.

It is well recognized that individuals who are being prescribed antipsychotic medications often face decisional conflict about their treatment options. An especially controversial decision is whether individuals should continue taking medication at the same dose or adjust the dose whilst monitoring their symptoms. This dilemma is the result of some uncertainty about the appropriate treatment strategy for long-term management of psychosis. The present project focuses on evaluating the feasibility and effectiveness of the use of a decision aid for making decisions about antipsychotic medication.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Randomization is accomplished using a HIPAA-compliant, Internet-based randomization service ( using permuted blocks of 5. Patients and the participating psychiatrist are not blinded to the condition assigned to them; however, they are not given any explicit information on the DA. The psychiatrist was provided with the DA and received information about it as the DA is delivered by the psychiatrist for patients who are randomized to receive it. The RA who recruit and administer assessments to participants is not blinded to condition, except at baseline.
Primary Purpose: Other
Official Title: Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early Psychosis
Actual Study Start Date : February 27, 2019
Actual Primary Completion Date : August 12, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Decision aid (DA)
a one-page DA for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics.
Behavioral: Decision aid
The chosen intervention is a one-page DA developed by the first author, published and fully described elsewhere (Zisman-Ilani et al., 2017; Zisman et al., 2018) for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics such as medication nonadherence and self-tapering. The DA format is a simple one-page table with rows containing frequently asked questions by patients about their treatment options and the benefits, risks, and implications of differing decisions. The columns display the treatment options available for the treatment decision in question: continuing, adjusting, or discontinuing antipsychotic medications.

No Intervention: Treatment as usual (TAU)
Treatment as usual without the DA

Primary Outcome Measures :
  1. Change in antipsychotics knowledge [ Time Frame: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ) ]
    Scale to assess change in knowledge about antipsychotic medications over time (9 items)

  2. Decision-making self-efficacy [ Time Frame: Post appointment interview (1 day of the appointment ) ]
    Decision Self-Efficacy (DSE) scale to assess decision self-efficacy (11 items)

  3. Decision-making attitudes [ Time Frame: Post appointment interview (1 day of the appointment ) ]
    Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)

  4. Decisional Conflict [ Time Frame: Post appointment interview (1 day of the appointment ) ]
    Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)

  5. Shared decision making [ Time Frame: Post appointment interview (1 day of the appointment ) ]
    collaboRATE scale to assess level of shared decision making after an appointment (3 items)

  6. Change in medication adherence [ Time Frame: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up . ]
    Brief Adherence Rating Scale (BARS) to assess change in medication adherence over time (8 items)

  7. Change in service use [ Time Frame: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up . ]
    Service Use and Resource Form for Monthly Items (SURF-M) scale to assess change in service use over time (66 items)

  8. Service engagement [ Time Frame: Baseline (Pre-appointment interview ) ]
    Service Engagement Scale (SES) to assess level of service engagement (14 items)

Secondary Outcome Measures :
  1. Apathy [ Time Frame: Baseline (Pre-appointment interview ) ]
    Marin Apathy Evaluation Scale to assess apathy (18 items)

  2. Attachment style [ Time Frame: Baseline (Pre-appointment interview ) ]
    Experiences in Close Relationships-Revised (ECR-R) Questionnaire to assess attachment style (36 items)

  3. Working alliance [ Time Frame: Baseline (Pre-appointment interview ) ]
    Working Alliance Inventory (WAI) to assess alliance (36)

  4. Trust [ Time Frame: Baseline (Pre-appointment interview ) ]
    Trust in the Medical Profession Scale to assess level of trust in the clinician (11 items)

  5. Cognitive functioning [ Time Frame: Baseline (Pre-appointment interview ) ]
    Brief Assessment of Cognition in Schizophrenia (BACS) - a battery to assess aspects of cognition such as verbal memory and attention.

  6. Insight [ Time Frame: Baseline (Pre-appointment interview ) ]
    Birchwood Insight Scale to assess insight to the illness (8 items)

  7. Self-stigma [ Time Frame: Baseline (Pre-appointment interview ) ]
    Internalized Stigma of Mental Illness (ISMI) Scale - Brief Version, to assess mental health self-stigma (10 items)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Aged 18 to 25 years
  • Experiencing early psychosis, defined as psychosis lasting 18 months or less between the time when threshold symptom criteria were reached (as determined by the admitting CSC program assessor) and the date of CSC program enrollment
  • Planning to attend a medication appointment with a participating CSC psychiatrist
  • Ability to speak and understand English
  • Ability to provide informed consent as assessed by research staff using procedures discussed by Carpenter et al. (2000) including a demonstrated understanding and recall of study procedures, rather than passive consent, and allowance of repetition of study procedures until there is understanding and recall.

Exclusion Criteria:

  • Have a legal guardian
  • Have identified co-occurring dementia, delirium, or intellectual disability that will likely affect their ability to provide informed consent or participate in the data collection procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04373590

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United States, Pennsylvania
Psychosis Education, Assessment, Care and Empowerment (PEACE)
Philadelphia, Pennsylvania, United States, 19123
Sponsors and Collaborators
Temple University
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yaara Zisman Ilani, Assistant Professor, Temple University Identifier: NCT04373590    
Other Study ID Numbers: 24734
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders