Cultivating Well-being in Severe Psychiatric Conditions

Study Overview
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Brief Summary
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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).

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

Conditions
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Wellbeing

Intervention / Treatment
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* Behavioral: FelizMente


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention: TAU + waiting list<br>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<br>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<br>* 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.<br>* Other names: Positive psychotherapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, severe psychiatric conditions, wellbeing, RCT, positive psychology, third-generation psychotherapy