Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme
NCT Number: NCT06556251
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Device Adherence
Interventions: DEVICE: PIPPEP App
Sponsor: Fundació Sant Joan de Déu
Collaborators: Parc Sanitari Sant Joan de Déu
Sex: ALL
Age: ADULT
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-18
Completion Date: 2027-12-31
Locations: Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, 08830, Spain

Summary:
This is a randomised, prospective, controlled trial in which one group (experimental group; GE) receives access to the PIPPEP (Intervention Programme for Early Psychosis) platform in addition to the treatment as usual (TAU) in PIPPEP, while the other group (control group; GC) receives only TAU in PIPPEP.

Main objective:

- To assess whether the use of the PIPPEP platform improves psychosocial and pharmacological treatment adherence in mental health programmes.

Secondary objectives:

* To assess the cost-effectiveness of the PIPPEP app.
* Evaluation of the dissemination of the platform.
* To assess the clinical and functional outcomes of patients using the PIPPEP platform in terms of 1) positive symptoms, 2) side effects of antipsychotic medication, 3) perceived social self-stigma, 4) risk assessment, 5) comorbid symptoms and 6) social functioning

The participants are 1) between 18 and 40 years of age, who are being treated in one of the PIPPEP programmes for early intervention in psychosis at Sanitary Parc Sant Joan de Déu and who meet the inclusion criteria "extremely high risk of psychosis", "critical phase or "first psychotic episode" and 2) agree to participate in the study and sign the informed consent form.

Primary Outcome Measures: Adherence to psychosocial treatment., Attendance at follow-up appointments with the therapeutic team. Lack of engagement or lack of adherence will be assumed if the patient remains uninterrupted for a period of at least one month despite the need for treatment:

1. does not turn up for scheduled visits and does not report in.
2. cannot be reached by telephone.
3. actively refuses contact with professionals and/or treatment.

If one of the above conditions is met, the person's last contact is considered the date of drop-out., Baseline, 6 months follow-up, 12 months follow-up
Secondary Outcome Measures: Direct costs use services, Direct costs related to the use of services (e.g. scheduled primary care visits, urgent General Practitioner visits,tests (TAC, Magnetic Resonance, Analytical)., Baseline, 6 months follow-up, 12 months follow-up|Penetration of the platform, Penetration of the platform (e.g. number of accesses to the platform, number of consultations with professionals)., Baseline, 6 months follow-up, 12 months follow-up|Indirect costs, Indirect costs (e.g. temporary inability to work, permanent disabilities, premature mortality (completed suicide, accident, other medical causes)., Baseline, 6 months follow-up, 12 months follow-up|Scale of the Impact of Perceived Symptoms in Schizophrenia, This is a self-administered scale that measures psychotic symptoms and the impact of symptoms on the patient's daily life., Baseline, 6 months follow-up, 12 months follow-up|Medication Adherence Scale-8 items, It is a 8 items is a structured, self-administered measure of medication adherence behaviour. It consists of 8 items and asks the person to answer yes or no to questions about medication adherence. Total scores are categorized as low (MMAS-8 score \<6), medium (MMAS-8 score 6 to \<8), and high (MMAS-8 score 8). Lower scores indicate worse adherence., Baseline, 6 months follow-up, 12 months follow-up|Scale for side effects of medication (UKU), This scale evaluates psychological, neurological, autonomic and other side effects of the medication. At the end there is a general assessment of the impairment that these effects may have on the patient's daily activities.It comprises ratings (0-4) of 48 single items, the higher the score, the greater the presence and severity of side effects., Baseline, 6 months follow-up, 12 months follow-up|The Beck Cognitive Insight Scale for Schizophrenia (BCIS), It is a self-administered scale that measures cognitive insight capacity, i.e., self-reflection as a metacognitive mechanism for analysing the symptoms of the illness that allows for continuous re-evaluation of inappropriate interpretations. A composite index, Cognitive Insight, is calculated as Reflectiveness minus Certainty (CI=R-C). The response format includes four Likert-type options: Never Agree (0), Somewhat Agree (1), Quite Agree (2) and Totally Agree (3), with a total score between 0 and 45. Higher scores on self-reflection and the composite index indicate greater cognitive insight, while lower scores on self-confidence indicate better cognitive insight., Baseline, 6 months follow-up, 12 months follow-up|Questionnaire on the consumption of toxic substances, Ad hoc checklist asking to indicate whether the person has consumed any of the following substances in the last 3 months: Caffeine or theine, tobacco, alcohol, cannabis, cocaine, amphetamines, opiates, hallucinogens, designer drugs, stimulants, benzodiazepines, inhalants or other drugs. The participant will be also asked to indicate the quantity and frequency of use., Baseline, 6 months follow-up, 12 months follow-up|Questionnaire on anxiety and depression, It consists of two ad hoc questions in which the person is asked a) to what extent they have felt nervous and/or stressed in the last week and b) to what extent they have felt sad and/or depressed. The person must answer on a scale from 0 to 5: "never", "almost never", "occasionally", "often" or "very often". The higher the score, the greater the presence and severity of the side effects, Baseline, 6 months follow-up, 12 months follow-up|Scale for self-perception of social stigmatisation (SSQ), This is a self-administered scale with a number of statements relating to the respondent's views on mental illness and their own experiences. It is required that the level is chosen according to the statements presented, on a scale of 1 to 7 (1 = Strongly agree, 2 = moderately agree, 3 = slightly agree, 4 = neither agree nor disagree, 5 = slightly disagree, 6 = moderately disagree, and 7 = strongly disagree). Higher scores indicate lower self-stigma., Baseline, 6 months follow-up, 12 months follow-up|Quality of life. Quality of Life Index (QLI-sp), This is a 10-item questionnaire covering the following dimensions: psychological well-being, physical well-being, self-care and independent functioning, occupational functioning, interpersonal functioning, emotional and social support, community support and services, self-actualisation or personal fulfilment, spiritual satisfaction and global quality of life assessment. Each item is rated by the respondent according to their personal and cultural view of this concept on a Likert scale from 0 to 10 points. The higher the score, the higher the respondent's quality of life., Baseline, 6 months follow-up, 12 months follow-up|Global Assessment of Functioning (GAF) scale, It is an heteroadministered scale that assesses the patient's functioning (including psychological, social and occupational activities) over the last 12 months on a scale between 0 and 100. Higher scores indicate higer level of functioning., Baseline, 6 months follow-up, 12 months follow-up