Cultivating Well-being in Subclinical Paranoia

Not Applicable

Completed

• Conditions: Wellbeing

• Registration Number: NCT04476771
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-10
• Study First Submitted: 2017-10-10
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-14
• Last Update Submitted: 2020-07-14
• Study First Posted: 2020-07-20
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Well-being at 12 weeks, 3 months and 12 months	Change baseline, 12 weeks, 3 months and 12 months	Satisfaction with life Scale ( Diener et al. 1985)

Secondary Outcome Measures

Name	Time	Method
Change from Well-beingDistress at 12 weeks, 3 months and 12 months	Change baseline, 12 weeks, 3 months and 12 months	Hospital Anxiety and Depression Scale (Bjelland et al. 2002)
Change from self-esteem at 12 weeks, 3 months and 12 months	Change baseline, 12 weeks, 3 months and 12 months	Rosenberg self-esteem scale (Rosenberg, 1965)
Change from Attachment at 12 weeks, 3 months and 12 months	Change baseline, 12 weeks, 3 months and 12 months	Relationship Questionnaire (Bartholomew and Horowitz, 1991)
Change from Paranoid ideation at 12 weeks, 3 months and 12 months	Change baseline, 12 weeks, 3 months and 12 months	Persecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006)
additional Outcome Measures Experience of trauma events	baseline	Life Events Checklist for DSM-5 (Gray, 2004)

Trial Locations

Locations (1)

Carmen Valiente; 🇪🇸 Pozuelo de Alarcón, Madrid, Spain