Cultivating Well-being in Severe Psychiatric Conditions

NCT04768959 | Completed

• 1 other identifier: UniversityComplutenseMadrid
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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).

Conditions

Wellbeing

Keywords

schizophrenia; severe psychiatric conditions; wellbeing; RCT; positive psychology; third-generation psychotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Self-esteem

  Change from self-esteem at 12 weeks and 6 months

• Attachment

  Change from Attachment at 12 weeks and 6 months

• Psychological Symptoms

  Change from Psychological Symptoms at 12 weeks and 6 months

• Experiential Avoidance

  Change from Experiential Avoidance at 12 weeks and 6 months

Study Arms (2)

No Intervention: TAU + waiting list

NO INTERVENTION

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: 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: FelizMente

Interventions

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.

Also known as: Positive psychotherapy

Experimental: TAU + Feliz-Mente Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) were aged 18-65 years
• \) had a minimum of motivation and commitment to participate in group therapy

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Carmen Valiente

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

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: Carmen Valiente Ots

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: October 25, 2017
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

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

Locations

ES (1)