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Cultivating Well-being in Subclinical Paranoia

Primary Purpose

Wellbeing

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Feliz-Mente (third generation psychotherapy)
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wellbeing

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carmen Valiente

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

TAU + waiting list

TAU + Feliz-Mente Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Well-being at 12 weeks, 3 months and 12 months
Psychological Well-Being Scales (Ryff, 1995)
Change from Well-being at 12 weeks, 3 months and 12 months
Satisfaction with life Scale ( Diener et al. 1985)

Secondary Outcome Measures

Change from Well-beingDistress at 12 weeks, 3 months and 12 months
Hospital Anxiety and Depression Scale (Bjelland et al. 2002)
Change from self-esteem at 12 weeks, 3 months and 12 months
Implicit self-esteem version: Go/No-Go Association Task (Nosek & Banaji, 2001)
Change from self-esteem at 12 weeks, 3 months and 12 months
Rosenberg self-esteem scale (Rosenberg, 1965)
Change from Attachment at 12 weeks, 3 months and 12 months
Relationship Questionnaire (Bartholomew and Horowitz, 1991)
Change from Paranoid ideation at 12 weeks, 3 months and 12 months
Persecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006)
additional Outcome Measures Experience of trauma events
Life Events Checklist for DSM-5 (Gray, 2004)

Full Information

First Posted
October 10, 2017
Last Updated
July 14, 2020
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04476771
Brief Title
Cultivating Well-being in Subclinical Paranoia
Official Title
Cultivating Well-being Beyond Symptomatology in Subclinical Paranoia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wellbeing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAU + waiting list
Arm Type
No Intervention
Arm Description
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.
Arm Title
TAU + Feliz-Mente Intervention
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Feliz-Mente (third generation psychotherapy)
Intervention Description
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 Outcome Measure Information:
Title
Change from Well-being at 12 weeks, 3 months and 12 months
Description
Psychological Well-Being Scales (Ryff, 1995)
Time Frame
Change baseline, 12 weeks, 3 months and 12 months
Title
Change from Well-being at 12 weeks, 3 months and 12 months
Description
Satisfaction with life Scale ( Diener et al. 1985)
Time Frame
Change baseline, 12 weeks, 3 months and 12 months
Secondary Outcome Measure Information:
Title
Change from Well-beingDistress at 12 weeks, 3 months and 12 months
Description
Hospital Anxiety and Depression Scale (Bjelland et al. 2002)
Time Frame
Change baseline, 12 weeks, 3 months and 12 months
Title
Change from self-esteem at 12 weeks, 3 months and 12 months
Description
Implicit self-esteem version: Go/No-Go Association Task (Nosek & Banaji, 2001)
Time Frame
Change baseline, 12 weeks, 3 months and 12 months
Title
Change from self-esteem at 12 weeks, 3 months and 12 months
Description
Rosenberg self-esteem scale (Rosenberg, 1965)
Time Frame
Change baseline, 12 weeks, 3 months and 12 months
Title
Change from Attachment at 12 weeks, 3 months and 12 months
Description
Relationship Questionnaire (Bartholomew and Horowitz, 1991)
Time Frame
Change baseline, 12 weeks, 3 months and 12 months
Title
Change from Paranoid ideation at 12 weeks, 3 months and 12 months
Description
Persecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006)
Time Frame
Change baseline, 12 weeks, 3 months and 12 months
Title
additional Outcome Measures Experience of trauma events
Description
Life Events Checklist for DSM-5 (Gray, 2004)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Carmen Valiente
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

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Cultivating Well-being in Subclinical Paranoia

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