Cultivating Well-being in Severe Psychiatric Conditions

Wellbeing Clinical Trial

— FelizMente2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04768959
• Other study ID #: UniversityComplutenseMadrid
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: September 25, 2019

Study information

• Verified date: February 2021
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Wellbeing

Intervention

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.

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	Well-being	Psychological Well-Being Scales (Ryff, 1995)	Change from Well-being at 12 weeks and 6 months
Primary	Well-being	Satisfaction with life Scale ( Diener et al. 1985)	Change from Well-being at 12 weeks and 6 months
Secondary	Self-esteem	Rosenberg self-esteem scale (Rosenberg, 1965)	Change from self-esteem at 12 weeks and 6 months
Secondary	Attachment	Relationship Questionnaire (Bartholomew and Horowitz, 1991)	Change from Attachment at 12 weeks and 6 months
Secondary	Psychological Symptoms	Symptom Checklist 90-Revised (SCL-90-R; Derogatis, 2002)	Change from Psychological Symptoms at 12 weeks and 6 months
Secondary	Experiential Avoidance	The Acceptance and Action Questionnaire (AAQ; Hayes et al.,2004)	Change from Experiential Avoidance at 12 weeks and 6 months