Cultivating Well-being in Severe Psychiatric Conditions

Not Applicable

Completed

• Conditions: Wellbeing
• Interventions: Behavioral: FelizMente

• Registration Number: NCT04768959
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

The multicomponet psychological 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 severe psychiatric conditions. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions 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) with the post-intervention measures of the control group (treatment as usual + waiting list).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-25
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Status Verified: 2021-02
• Study First Submitted: 2021-02-21
• Study First Submitted QC: 2021-02-21
• Last Update Submitted: 2021-02-21
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• 1. were aged 18-65 years
• 2. had a minimum of motivation and commitment to participate in group therapy

Exclusion Criteria

• 1. limited cognitive resources or serious formal thinking disorder and/or
• 2. a concurrent diagnosis of substance dependence or a severe personality disorder that could interfere with benefiting from a psychotherapy group.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: TAU + Feliz-Mente Intervention	FelizMente	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.

Primary Outcome Measures

Name	Time	Method
Well-being	Change from Well-being at 12 weeks and 6 months	Satisfaction with life Scale ( Diener et al. 1985)

Secondary Outcome Measures

Name	Time	Method
Attachment	Change from Attachment at 12 weeks and 6 months	Relationship Questionnaire (Bartholomew and Horowitz, 1991)
Experiential Avoidance	Change from Experiential Avoidance at 12 weeks and 6 months	The Acceptance and Action Questionnaire (AAQ; Hayes et al.,2004)
Self-esteem	Change from self-esteem at 12 weeks and 6 months	Rosenberg self-esteem scale (Rosenberg, 1965)
Psychological Symptoms	Change from Psychological Symptoms at 12 weeks and 6 months	Symptom Checklist 90-Revised (SCL-90-R; Derogatis, 2002)

Trial Locations

Locations (1)

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