Please select the eligibility criteria that correspond to the clinical trial below.
Title: Meaningful Change With the Method Guided Self-Determination - a Randomised Controlled Study for Patients Diagnosed With Schizophrenia.
Brief Summary: Background:

Rehospitalisation and discontinued treatment are common among patients with schizophrenia and is often associated with lack of insight into the illness. Improving patients' insight has been attempted through psychoeducation and standard treatment but without any considerable change. A newly developed method, Guided Self-Determination (GSD), originally developed and proved effective in difficult diabetes care has been adjusted to patients with schizophrenia. A qualitative evaluation of GSD has shown a positive influence on patients' insight into the illness.

Aim and hypotheses: The aim of the study is to evaluate the effects of the method GSD in the care of patients with schizophrenia compared to treatment as usual. The following hypotheses will be tested:

The method GSD will improve: Cognitive and clinical insight in patients, various domains of recovery, patients' self-esteem, psychopathology and social functioning.

Material and method:

The study design is a randomised controlled trial. The participants are diagnosed with schizophrenia and schizoaffective disorder, receiving treatment in 3 Assertive Outreach Teams and 3 Psychosis Teams in Region North. Participants complete four self-rating questionnaires, a demographic data sheet, an interview concerning psychopathology and an assessment of social functioning at baseline, and after 3, 6, and 12 month. All assessments will be conducted by the investigator, except for the assessment of social functioning, that will be measures by community nurses. Intervention with the method GSD will also be conducted by the community nurses but under supervision from the investigator. Fifty patients are randomly assigned to immediate receipt of individual training with the method GSD (intervention group) and 50 to a 12-month waiting list for individual training with the method GSD (control group).

Perspectives:

In mental health nursing practice in Denmark there is no tradition for empirical research as the basis of psychiatric nursing - unverified theories or general empirical consensus of good clinical practice are often the foundation of psychiatric nursing. If the method GSD proves effective in the care of patients with schizophrenia, this study contributes to an evidence based nursing intervention, which is ready for further research on implementation in mental health nursing practice.


Options:
A: Inclusion Criteria:

* Patient's hospital record meeting the criteria for schizophrenia according to ICD-10 F.20.0-9 or schizoaffective disorder according to ICD-10 F.25.0-9
* Age 18 - 70 years at the time of inclusion
* Ability to understand, speak and write Danish - assessed by the community nurse
* Informed written consent
* receiving treatment in an assertive outreach team or psychosis team in region north in Denmark

Exclusion Criteria:

* Previous participation with the method GSD
* Patients who are mentally handicapped or diagnosed with any kind of dementia or an organic brain disease according to their hospital record
* In need of an interpreter to understand, speak and write Danish
* Withdrawal of informed consent
B: Inclusion Criteria:

* Adults of both sexes aged 18+
* A diagnosis of schizophrenia, schizotypal or delusional disorder (ICD-10 codes: F20-F29)
* The patient have received treatment for a maximum of 18 months at the start of the intervention from one of five participating OPUS centre in the Mental Health Services of the Capital Region of Denmark

Exclusion Criteria:

* Do not understand or speak Danish
* Unable to give written informed consent to participate in the trial at the described terms
* Are participating in other research studies involving OPUS treatment and an app
* Do not have daily access to a smartphone
* Are suffering of mental retardation or dementia (F. 70-F.79, F.00-F.03)
C: Inclusion Criteria:

* Aged 18+
* In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling)

Exclusion Criteria:

* none
D: Inclusion Criteria:

* Eligible primary clinicians will include all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will include primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also include nurse practitioners and physician assistants playing a "primary role" with eligible patients. A "primary role" denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated
* Eligible interprofessional team members will include nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team.
* Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic criteria include: 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values \<35% predicted or oxygen dependence or restrictive lung disease with a TLC \< 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of \>17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of \< 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness or older than 90 years. Additional criteria include: PAH w. 6MWD \<250m, restrictive lung disease (IPF, ILD) w/ TLC \<50%, and cystic fibrosis with FEV1 \< 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires.
* Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, "family member" is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires.

Exclusion Criteria:

* Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities.

Answer: A