Cultivating Well-being in Subclinical Paranoia

Wellbeing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476771
• Other study ID #: ComplutenseMadrid
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: September 25, 2019

Study information

• Verified date: July 2020
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wellbeing

Intervention

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.

Locations

Country	Name	City	State
Spain	Carmen Valiente	Pozuelo de Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	additional Outcome Measures Experience of trauma events	Life Events Checklist for DSM-5 (Gray, 2004)	baseline