Skip to main content
OpenTrials
Completed

NCT Number: NCT04768959

Cultivating Well-being in Severe Psychiatric Conditions

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wellbeing Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmen Valiente

Pozuelo de Alarcón, Madrid, 28223, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FelizMente

Behavioral

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

Primary outcomes

  1. Well-being

    Time frame: Change from Well-being at 12 weeks and 6 months

    Psychological Well-Being Scales (Ryff, 1995)

  2. Well-being

    Time frame: Change from Well-being at 12 weeks and 6 months

    Satisfaction with life Scale ( Diener et al. 1985)

Secondary outcomes

  1. Self-esteem

    Time frame: Change from self-esteem at 12 weeks and 6 months

    Rosenberg self-esteem scale (Rosenberg, 1965)

  2. Attachment

    Time frame: Change from Attachment at 12 weeks and 6 months

    Relationship Questionnaire (Bartholomew and Horowitz, 1991)

  3. Psychological Symptoms

    Time frame: Change from Psychological Symptoms at 12 weeks and 6 months

    Symptom Checklist 90-Revised (SCL-90-R; Derogatis, 2002)

  4. Experiential Avoidance

    Time frame: Change from Experiential Avoidance at 12 weeks and 6 months

    The Acceptance and Action Questionnaire (AAQ; Hayes et al.,2004)

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Acronym: FelizMente2

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 24, 2021
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.