Feeling Safe Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About this trial
The goal of this study is to assess the acceptability and satisfaction with the psychological intervention Sentirnos Seguros (Feeling Safe) in people with psychotic disorders and positive delusional symptoms.
The main questions it aims to answer are:
* Study participants will report high levels of acceptability and satisfaction with the Sentirnos Seguros programme. * The Sentirnos Seguros intervention will be beneficial for participants at a clinical and functional level, with higher scores in the post-treatment phase compared to the pre-treatment phase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women aged 18 years and older
Diagnosis of schizophrenia spectrum disorders and other psychotic disorders according to DSM-5
Score ≥ 4 on the delusions item of the Positive and Negative Syndrome Scale (PANSS)
Presence of ideas of persecution with a degree of conviction > 60% in the last 3 months
Disqualifiers
Presence of intellectual disability
Meet DSM-5 criteria for other mental health disorders, except for substance-related and addictive disorders
Trial design
Design model
Single group
Treatments tested in this trial
Sentirnos Seguros
Other interventionThe Sentirnos Seguros (Feeling Safe) programme is modular, personalised and includes the patient's preferences. The following modules are offered: improving sleep, reducing worry, increasing self-confidence, reducing the impact of voices, and feeling safe enough.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Compliance related to the total number of successful appointments made
Compliance will be assessed by calculating the frequency of successful appointments from baseline to 6 months (end of therapy)
Time frame
From baseline to 6 months (end of therapy)2
Number of drop-outs
The number of drop-outs will be assessed by calculating the proportion of participants who do not complete the study protocol
Time frame
From baseline to 6 months (end of treatment)3
Acceptability, measured with an ad hoc questionnaire
Acceptability with the intervention will be assessed by an ad hoc questionnaire to measure the dimensions of acceptability: perceived utility, perceived ease of use, barriers, and intention to use
Time frame
From baseline to 6 months (end of the treatment)4
Satisfaction with the intervention, measured with the Client Satisfaction Questionnaire (CSQ-8)
Satisfaction with the intervention will be assessed using the CSQ-8. A 4-point Likert scale is used to rate each item (1 = very dissatisfied; 4 = very satisfied), yielding a total score ranging from 8 to 32. A low score (close to 8) indicates low satisfaction with the services received, and a high score (close to 32) indicates high satisfaction with them.
Time frame
From baseline to 6 months (end of the treatment)Secondary outcomes
1
Change in the severity of psychotic symptoms, measured with the Positive and Negative Syndrome Scale (PANSS)
The severity of psychotic symptoms will be assessed using the PANSS. This scale includes 30 items (7 for positive symptoms, 7 for negative symptoms, and 16 for general psychopathology). A 7-point Likert scale is used to rate each item (1 = not present; 7= most severe). The total score is the sum of all items. No specific cut-off scores have been established for the PANSS. The higher the score, the greater the clinical severity.
Time frame
Changes in baseline scores at 6 months2
Change in severity of hallucinations and delusions, measured with the Psychotic Symptom Rating Scales (PSYRATS)
The severity of hallucinations and delusions will be assessed using the PSYRATS. It consists of two subscales, one for hallucinations and one for delusions, each with 17 items, with Likert-type responses ranging from 0 to 5. The final score is obtained by adding the scores for each item. It can range from 0 to 44. No specific cut-off scores have been established for the PSYRATS. The higher the score, the more severe the hallucinations/delusions.
Time frame
Changes in baseline scores at 6 months3
Change in depression severity, measured with the Calgary Depresión Scale for Schizophrenia (CDSS)
The depression severity is assessed using the CDSS. This scale includes 9 items that are scored with a Likert scale that ranges from 0 (absent) to 3 (severe). The total score is the sum of all items. The higher the score, the greater the clinical severity. To identify the absence/presence of depression, a score ≥ 5 is the cut-off point.
Time frame
Changes in baseline scores at 6 months4
Change in the delusional conviction severity measured with the delusional conviction-analogue visual scale (DC-VAS)
Change in the delusional conviction severity will be assessed using the DC-VAS. This scale rates the degree of conviction of the delusional idea from 0 to 10.
Time frame
Changes in baseline scores at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov