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Completed

NCT Number: NCT04476771

Cultivating Well-being in Subclinical Paranoia

The 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 subclinical paranoia. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions by the use of a mobile application 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 and the daily use of a mobile application of the program) with the post-intervention measures of the control group (treatment as usual + waiting list).

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Key information

Conditions

Wellbeing

Age range

18 year–35 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

  • Participants between 18 and 35 years old
  • At least two standard deviations above mean on the scales of distress, suspicion and /or interpersonal sensitivity in the SCL-90 questionnaire.

Exclusion criteria

  • Participants with borderline personality disorder
  • Participants with substance use disorders and /or
  • Participants with severe cognitive impairment.

Treatment and study plan

Feliz-Mente (third generation psychotherapy)

Behavioral

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.

Primary outcomes

  1. Change from Well-being at 12 weeks, 3 months and 12 months

    Time frame: Change baseline, 12 weeks, 3 months and 12 months

    Psychological Well-Being Scales (Ryff, 1995)

  2. Change from Well-being at 12 weeks, 3 months and 12 months

    Time frame: Change baseline, 12 weeks, 3 months and 12 months

    Satisfaction with life Scale ( Diener et al. 1985)

Secondary outcomes

  1. Change from Well-beingDistress at 12 weeks, 3 months and 12 months

    Time frame: Change baseline, 12 weeks, 3 months and 12 months

    Hospital Anxiety and Depression Scale (Bjelland et al. 2002)

  2. Change from self-esteem at 12 weeks, 3 months and 12 months

    Time frame: Change baseline, 12 weeks, 3 months and 12 months

    Implicit self-esteem version: Go/No-Go Association Task (Nosek & Banaji, 2001)

  3. Change from self-esteem at 12 weeks, 3 months and 12 months

    Time frame: Change baseline, 12 weeks, 3 months and 12 months

    Rosenberg self-esteem scale (Rosenberg, 1965)

  4. Change from Attachment at 12 weeks, 3 months and 12 months

    Time frame: Change baseline, 12 weeks, 3 months and 12 months

    Relationship Questionnaire (Bartholomew and Horowitz, 1991)

  5. Change from Paranoid ideation at 12 weeks, 3 months and 12 months

    Time frame: Change baseline, 12 weeks, 3 months and 12 months

    Persecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006)

  6. additional Outcome Measures Experience of trauma events

    Time frame: baseline

    Life Events Checklist for DSM-5 (Gray, 2004)

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

Cultivating Well-being Beyond Symptomatology in Subclinical Paranoia: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 20, 2020
Registry last updated
Jul 20, 2020

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.

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