Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The intervention is called Feliz-Mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with subclinical paranoia. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions by the use of a mobile application to improve treatment adherence and daily practice. The design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention and the daily use of a mobile application of the program) with the post-intervention measures of the control group (treatment as usual + waiting list).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU + waiting list | No Intervention | Feliz-Mente (third generation psychotherapy):The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party. | |
| TAU + Feliz-Mente Intervention | Experimental | Feliz-Mente (third generation psychotherapy):The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feliz-Mente (third generation psychotherapy) | Behavioral | The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Well-being at 12 weeks, 3 months and 12 months | Psychological Well-Being Scales (Ryff, 1995) | Change baseline, 12 weeks, 3 months and 12 months |
| Change from Well-being at 12 weeks, 3 months and 12 months | Satisfaction with life Scale ( Diener et al. 1985) | Change baseline, 12 weeks, 3 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Well-beingDistress at 12 weeks, 3 months and 12 months | Hospital Anxiety and Depression Scale (Bjelland et al. 2002) | Change baseline, 12 weeks, 3 months and 12 months |
| Change from self-esteem at 12 weeks, 3 months and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmen Valiente | Pozuelo de Alarcón | Madrid | 28223 | Spain |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Implicit self-esteem version: Go/No-Go Association Task (Nosek & Banaji, 2001)
| Change baseline, 12 weeks, 3 months and 12 months |
| Change from self-esteem at 12 weeks, 3 months and 12 months | Rosenberg self-esteem scale (Rosenberg, 1965) | Change baseline, 12 weeks, 3 months and 12 months |
| Change from Attachment at 12 weeks, 3 months and 12 months | Relationship Questionnaire (Bartholomew and Horowitz, 1991) | Change baseline, 12 weeks, 3 months and 12 months |
| Change from Paranoid ideation at 12 weeks, 3 months and 12 months | Persecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006) | Change baseline, 12 weeks, 3 months and 12 months |
| additional Outcome Measures Experience of trauma events | Life Events Checklist for DSM-5 (Gray, 2004) | baseline |