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Completed

NCT Number: NCT04373590

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychosis Education, Assessment, Care and Empowerment (PEACE)

Philadelphia, Pennsylvania, 19123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decision aid

Behavioral

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Official study title

Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early Psychosis

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 4, 2020
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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