Cultivating Well-being in Subclinical Paranoia

Study Overview
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Brief Summary
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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).

Official Title
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Cultivating Well-being Beyond Symptomatology in Subclinical Paranoia: A Randomized Controlled Trial

Conditions
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Wellbeing

Intervention / Treatment
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* Behavioral: Feliz-Mente (third generation psychotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants between 18 and 35 years old At least two standard deviations above mean on the scales of distress, suspicion and /or interpersonal sensitivity in the SCL-90 questionnaire. Exclusion Criteria: Participants with borderline personality disorder Participants with substance use disorders and /or Participants with severe cognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: TAU + waiting list<br>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. | |
| Experimental: TAU + Feliz-Mente Intervention<br>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. | Behavioral: Feliz-Mente (third generation psychotherapy)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |