Cultivating Well-being in Subclinical Paranoia

NCT ID: NCT04476771

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2019-09-25

Brief Summary

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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).

Detailed Description

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Conditions

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Wellbeing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TAU + waiting list

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

TAU + Feliz-Mente Intervention

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.

Group Type EXPERIMENTAL

Feliz-Mente (third generation psychotherapy)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Carmen Valiente Ots

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Carmen Valiente

Pozuelo de Alarcón, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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ComplutenseMadrid

Identifier Type: -

Identifier Source: org_study_id

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