Cultivating Well-being in Subclinical Paranoia

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

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).

Study Overview

• Status: Completed
• Conditions: Wellbeing
• Intervention / Treatment: Behavioral: Feliz-Mente (third generation psychotherapy)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Carmen Valiente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: TAU + waiting list; 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; 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): September 25, 2019
• Study Completion (Actual): September 25, 2019

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Paranoid Disorders
• Other Study ID Numbers: ComplutenseMadrid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No