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Cultivating Well-being in Subclinical Paranoia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04476771
Enrollment
50
Registered
2020-07-20
Start date
2017-10-10
Completion date
2019-09-25
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wellbeing

Brief summary

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).

Interventions

BEHAVIORALFeliz-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.

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Well-being at 12 weeks, 3 months and 12 monthsChange baseline, 12 weeks, 3 months and 12 monthsPsychological Well-Being Scales (Ryff, 1995)

Secondary

MeasureTime frameDescription
Change from Well-beingDistress at 12 weeks, 3 months and 12 monthsChange baseline, 12 weeks, 3 months and 12 monthsHospital Anxiety and Depression Scale (Bjelland et al. 2002)
Change from self-esteem at 12 weeks, 3 months and 12 monthsChange baseline, 12 weeks, 3 months and 12 monthsImplicit self-esteem version: Go/No-Go Association Task (Nosek & Banaji, 2001)
Change from Attachment at 12 weeks, 3 months and 12 monthsChange baseline, 12 weeks, 3 months and 12 monthsRelationship Questionnaire (Bartholomew and Horowitz, 1991)
Change from Paranoid ideation at 12 weeks, 3 months and 12 monthsChange baseline, 12 weeks, 3 months and 12 monthsPersecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006)
additional Outcome Measures Experience of trauma eventsbaselineLife Events Checklist for DSM-5 (Gray, 2004)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026