Towards a Personalized Medicine Approach to Psychological Treatment for Psychosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Polish Academy of Sciences
- Enrollment
- 252
- Locations
- 6
- Primary Endpoint
- Sociodemographic Questionnaire
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The main aim of the clinical trial is to validate the Machin Learning (ML) predictive model for personalized Metacognitive Training (MCT) by comparing classic MCT to personalized MCT (P-MCT) among patients diagnosed with psychosis who had a history of delusions. More precisely, we will compare classic MCT to P-MCT in a randomized clinical trial.We expect personalised MCT treatment will see more improvement than classical MCT in outcome variables measuring treatment efficacy.
Detailed Description
This prospective study will consist of a pilot, double-blind clinical trial comparing Personalized MCT (P-MCT) to classical MCT. This pilot study will serve as a basis to validate the profiling strategy of patients and to test whether a personalized approach to psychological interventions (P-MCT) is more effective than non-personalized interventions (classical MCT). The experimental intervention will be P-MCT. Baseline data of the patients randomized to the P-MCT and classical MCT group will be entered into the prototype platform, which will output the patient's profile and an estimate of response to MCT and the specific homeworks to be included in the intervention. MCT dedicates one session to attributional biases, two to Jumping to Conclusions Bias, one to belief change, two to empathy, one to meta-memory, and one to self-esteem and two additional for self-esteem and stigma. The personalized MCT will have personalized homeworks that target specific factors, in which patients have deficits. For instance, patients with deficits in self-esteem (based on the results from the platform) will be provided with homework addressing this aspect. We identified five domains that will be personalized: 1. self-esteem; 2. cognitive insight; 3. delusions; 4. positive symptoms; 5. completion. All interventions will be conducted by psychologists or mental-health professionals trained in MCT. All the treatments will be conducted on-site and online. Both conditions patients will receive 10 sessions of MCT. Control intervention: The control group is an active group that will receive classical MCT for psychosis following the current program. Duration of intervention per patient: 10 weeks (1 session per week of one hour of length). Patients will be assessed at baseline, post-treatment, and 6-month follow up. The sample will include patients with Schizophrenia Spectrum Disorders (n=252) from five clinical center (Poland, Germany, France, Chile and Spain).
Investigators
Łukasz Gawęda
Associate Professor
Polish Academy of Sciences
Eligibility Criteria
Inclusion Criteria
- •Inpatients and outpatients with a DSM-IV-R and DSM-5 diagnosis of non-affective psychosis or Clinical High Risk for psychosis.
- •Presence of positive symptoms during the last year (PANSS delusions, suspiciousness or grandiosity \>=3).
- •Adults, 18 - 65 years of age
- •Stable condition with no expected changes in medication (information from clinical services).
- •Lack of severe cognitive deficits (global assessment or/and information from clinical services);
Exclusion Criteria
- •Having received MCT in the previous year.
- •Neurological disorder, a history of head trauma or premorbid IQ below 70 (based on medical reports and/or other sources);
- •A score above 5 in the "Hostility" and the "Suspiciousness" items of the PANSS Positive subscale (to preserve group dynamics).
- •aggressive behavior (reports from clinical services if available)
- •High risk of suicide (verified with DIAMOND)
Outcomes
Primary Outcomes
Sociodemographic Questionnaire
Time Frame: Baseline
A sociodemographic sheet will be captured the following information: age, gender/sex, marital status, years of education, living situation, number of siblings, whether they live in rural or urban areas, employment status, symptom onset, previous hospitalisations, history of suicide attempts, family mental health history, current substance use, current pharmacological treatment (name and dosage), diagnosis (options: schizophrenia,unspecified psychotic disorder, schzoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder), comorbidity, other medical illnesses, and in female patients, age at menarche, age at menopause, hormone treatment (if applicable), menstrual cycle description, date of last menstrual period, amenorrhoea.
PSYRATS
Time Frame: baseline, post-treatment and 6-month follow-up
Psychotic Symptom Rating Scale. The PSYRATS comprises hallucinations (11 items) and delusions (6 items) subscales, each one designed to assess the psychological aspects of the symptoms on a five-point scale, from 0 to 4.
PANSS
Time Frame: baseline, post-treatment and 6-month follow-up
The Positive and Negative Syndromes Scale.PANSS is a semi-structured interview assessing 30 symptoms on a 7-point scale, from 1 (absent) to 7 (extreme). Symptoms are rated over seven days prior to the assessment.
RSES
Time Frame: baseline, post-treatment and 6-month follow-up
Rosenberg's Self-Esteem Scale.A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be unidimensional. All items are answered using a 4-point Likert scale ranging from strongly agree to strongly disagree.
BCIS
Time Frame: baseline, post-treatment and 6-month follow-up
Beck Cognitive Insight Scale.The BCIS aims to assess patients' self-reflectiveness about cognitive processes and problems and (over-) confidence in decision-making. The self-report questionnaire consists of 15 items which measure "self-reflectiveness" (9 items; e.g., "At times, I have misunderstood other people's attitudes towards me.") and "self-certainty" (6 items; e.g., "My interpretations of my experiences are definitely right."). A composite index of the BCIS termed "cognitive insight" is calculated by subtracting the self-certainty subscore from the self-reflectiveness subscore.
Secondary Outcomes
- GAF(baseline, post-treatment and 6-month follow-up)
- DIAMOND(baseline)
- WHOQOL-BREF(baseline, post-treatment and 6-month follow-up)
- TEC(baseline)
- CBQp(baseline, post-treatment and 6-month follow-up)
- ISMI(baseline, post-treatment and 6-month follow-up)
- QSLE-SV(baseline, post-treatment and 6-month follow-up)
- RFQ(baseline, post-treatment and 6-month follow-up)
- ISI(baseline, post-treatment and 6-month follow-up)
- SUMD(baseline, post-treatment and 6-month follow-up)
- B-IRI(baseline, post-treatment and 6-month follow-up)
- BHS(baseline, post-treatment and 6-month follow-up)
- PHQ-9(baseline, post-treatment and 6-month follow-up)
- IPSAQ(baseline, post-treatment and 6-month follow-up)
- Satisfaction with MCT treatment(post-treatment)
- TMT(baseline, post-treatment and 6-month follow-up)
- Fish Task(baseline, post-treatment and 6-month follow-up)
- BCFT(baseline, post-treatment and 6-month follow-up)
- The Hinting Task(baseline, post-treatment and 6-month follow-up)
- Monitoring symptoms during MCT(post-treatment)