Cultivating Well-being in Severe Psychiatric Conditions (FelizMente2)

Cultivating Well-being Beyond Symptomatology in Severe Psychiatric Conditions: A Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Wellbeing
• Intervention / Treatment: Behavioral: FelizMente

• Study Type: Interventional
• Enrollment (Actual): 140
• 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 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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: No Intervention: TAU + waiting list; This control group is a waiting list group. Participants received treatment as usual (TAU). Once the RCT is finished, participants have the chance to participate in the intervention group.
Experimental: 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: FelizMente; The intervention aims to improve well-being, without denying the existence of symptoms or problems, focusing on generating positive emotions and actions congruent with the person's values through 11 weekly 90-minute group sessions. The multi-component intervention manual was composed of evidence-based exercises of Positive Psychoterapy Interventions, Acceptance and Commitment Therapy and Mindfulness and was theory driven according the broaden-and-build-theory (Fredrickson, 2001) and the self-serving model of paranoia (Murphy et al., 2018). It was also informed by previous pilot studies carried out on people with paranoid tendencies (see Valiente et al., 2020) and with Severe Psyquiatric Condition samples.; Other Names: Positive psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being	Psychological Well-Being Scales (Ryff, 1995)	Change from Well-being at 12 weeks and 6 months
Well-being	Satisfaction with life Scale ( Diener et al. 1985)	Change from Well-being at 12 weeks and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: schizophrenia; RCT; positive psychology; wellbeing; severe psychiatric conditions; third-generation psychotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: UniversityComplutenseMadrid

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; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No