Cultivating Well-being in Subclinical Paranoia

NCT04476771 | Completed

• 1 other identifier: ComplutenseMadrid
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Wellbeing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change from Well-beingDistress at 12 weeks, 3 months and 12 months

  Change baseline, 12 weeks, 3 months and 12 months

• Change from self-esteem at 12 weeks, 3 months and 12 months

  Change baseline, 12 weeks, 3 months and 12 months

• Change from self-esteem at 12 weeks, 3 months and 12 months

  Change baseline, 12 weeks, 3 months and 12 months

• Change from Attachment at 12 weeks, 3 months and 12 months

  Change baseline, 12 weeks, 3 months and 12 months

• Change from Paranoid ideation at 12 weeks, 3 months and 12 months

  Change baseline, 12 weeks, 3 months and 12 months

Study Arms (2)

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.

Behavioral: Feliz-Mente (third generation psychotherapy)

Interventions

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.

TAU + Feliz-Mente Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participants with borderline personality disorder
• Participants with substance use disorders and /or
• Participants with severe cognitive impairment.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Carmen Valiente

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: July 20, 2020
• Study Start: October 10, 2017
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (1)