Early PsychosisNCT04373590
Decision-making and Decision Support Among Emerging Adults With First Episode Psychosis
A study testing Decision aid in people with Early Psychosis, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Psychosis
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 30 Aug 2020
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychosis Education, Assessment, Care and Empowerment (PEACE)
Philadelphia, Pennsylvania, 19123
About this study
Official title: Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early 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.
Read the 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.
- Conditions
- Early Psychosis
- Being tested
- Decision aid
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid (DA) | Experimental | a one-page DA for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics. Receives: Behavioral: Decision aid |
| Treatment as usual (TAU) | No intervention | Treatment as usual without the DA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in antipsychotics knowledge
Scale to assess change in knowledge about antipsychotic medications over time (9 items)
Measured: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment )
Decision-making self-efficacy
Decision Self-Efficacy (DSE) scale to assess decision self-efficacy (11 items)
Measured: Post appointment interview (1 day of the appointment )
Decision-making attitudes
Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)
Measured: Post appointment interview (1 day of the appointment )
Decisional Conflict
Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)
Measured: Post appointment interview (1 day of the appointment )
Shared decision making
collaboRATE scale to assess level of shared decision making after an appointment (3 items)
Measured: Post appointment interview (1 day of the appointment )
Change in medication adherence
Brief Adherence Rating Scale (BARS) to assess change in medication adherence over time (8 items)
Measured: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .
Change in service use
Service Use and Resource Form for Monthly Items (SURF-M) scale to assess change in service use over time (66 items)
Measured: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment ), 3 months follow-up , 6 months follow-up .
Service engagement
Service Engagement Scale (SES) to assess level of service engagement (14 items)
Measured: Baseline (Pre-appointment interview )
Secondary outcomes (7)
Apathy
Marin Apathy Evaluation Scale to assess apathy (18 items)
Measured: Baseline (Pre-appointment interview )
Attachment style
Experiences in Close Relationships-Revised (ECR-R) Questionnaire to assess attachment style (36 items)
Measured: Baseline (Pre-appointment interview )
Working alliance
Working Alliance Inventory (WAI) to assess alliance (36)
Measured: Baseline (Pre-appointment interview )
Trust
Trust in the Medical Profession Scale to assess level of trust in the clinician (11 items)
Measured: Baseline (Pre-appointment interview )
Cognitive functioning
Brief Assessment of Cognition in Schizophrenia (BACS) - a battery to assess aspects of cognition such as verbal memory and attention.
Measured: Baseline (Pre-appointment interview )
Insight
Birchwood Insight Scale to assess insight to the illness (8 items)
Measured: Baseline (Pre-appointment interview )
Self-stigma
Internalized Stigma of Mental Illness (ISMI) Scale - Brief Version, to assess mental health self-stigma (10 items)
Measured: Baseline (Pre-appointment interview )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start27 Feb 2019
- Primary completion12 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaara Zisman Ilani, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373590
- Sponsor's protocol ID
- 24734
- Status last verified
- Feb 2021
- First submitted
- 29 Apr 2020
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zisman-Ilani Y, Shern D, Deegan P, Kreyenbuhl J, Dixon L, Drake R, Torrey W, Mishra M, Gorbenko K, Elwyn G. Continue, adjust, or stop antipsychotic medication: developing and user testing an encounter decision aid for people with first-episode and long-term psychosis. BMC Psychiatry. 2018 May 22;18(1):142. doi: 10.1186/s12888-018-1707-x.
PubMed 29788933Zisman-Ilani Y, Hurford I, Bowen A, Salzer M, Thomas EC. Evaluating the feasibility of a decision aid to promote shared decision making among young adults with first-episode psychosis: protocol for a pilot study. Pilot Feasibility Stud. 2021 Jan 11;7(1):22. doi: 10.1186/s40814-020-00757-0.
PubMed 33431018
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Healthcare Decision-Making and Decision Support Among Emerging Adults Enrolled in Coordinated Specialty Care for Early Psychosis
- ClinicalTrials.gov ID
- NCT04373590
- Acronym / sponsor ID
- 24734
- Conditions
- Early Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 12 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid (DA) | Experimental | Behavioral: Decision aida one-page DA for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics. |
| Treatment as usual (TAU) | No intervention | –Treatment as usual without the DA |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aidThe 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. | Behavioural | Decision aid (DA) |
Primary outcome
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)
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)
Decision-making attitudes
Time frame: Post appointment interview (1 day of the appointment )
Decision Attitude Scale (DAS) to assess decision-making attitudes (10 items)
Decisional Conflict
Time frame: Post appointment interview (1 day of the appointment )
Decisional Conflict Scale (DCS) to assess level of decisional conflict (15 items)
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)
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)
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)
Service engagement
Time frame: Baseline (Pre-appointment interview )
Service Engagement Scale (SES) to assess level of service engagement (14 items)
7 secondary outcomes
Apathy
Time frame: Baseline (Pre-appointment interview )
Attachment style
Time frame: Baseline (Pre-appointment interview )
Working alliance
Time frame: Baseline (Pre-appointment interview )
Trust
Time frame: Baseline (Pre-appointment interview )
Cognitive functioning
Time frame: Baseline (Pre-appointment interview )
Insight
Time frame: Baseline (Pre-appointment interview )
Self-stigma
Time frame: Baseline (Pre-appointment interview )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Results publication: PubMed 29788933Zisman-Ilani Y, Shern D, Deegan P, Kreyenbuhl J, Dixon L, Drake R, Torrey W, Mishra M, Gorbenko K, Elwyn G. Continue, adjust, or stop antipsychotic medication: developing and user testing an encounter decision aid for people with first-episode and long-term psychosis. BMC Psychiatry. 2018 May 22;18(1):142. doi: 10.1186/s12888-018-1707-x.
- Derived from this study: PubMed 33431018Zisman-Ilani Y, Hurford I, Bowen A, Salzer M, Thomas EC. Evaluating the feasibility of a decision aid to promote shared decision making among young adults with first-episode psychosis: protocol for a pilot study. Pilot Feasibility Stud. 2021 Jan 11;7(1):22. doi: 10.1186/s40814-020-00757-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Early Psychosis, run by Temple University 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 5 inclusion and 2 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 15 Feb 2021. 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?
Change in antipsychotics knowledge (time frame: Baseline (Pre-appointment interview ) and post appointment interview ( same 1 day of the appointment )). The study lists 8 primary outcomes in all. 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 NCT04373590, which also lists 2 linked publications.
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 15 Feb 2021; AzTrials last refreshed its copy on 26 Oct 2026.