WellbeingNCT04476771
Cultivating Well-being in Subclinical Paranoia
A study testing Feliz-Mente (third generation psychotherapy) in people with Wellbeing, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Wellbeing
- What is being tested?
- Feliz-Mente (third generation psychotherapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2017to 25 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Participants with borderline personality disorder
- Participants with substance use disorders and /or
- Participants with severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cultivating Well-being Beyond Symptomatology in Subclinical Paranoia: A Randomized Controlled Trial
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).
- Conditions
- Wellbeing
- Being tested
- Feliz-Mente (third generation psychotherapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feliz-Mente (third generation psychotherapy)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TAU + waiting list | No 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. |
| TAU + Feliz-Mente Intervention | Experimental | 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. Receives: Behavioral: Feliz-Mente (third generation psychotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Well-being at 12 weeks, 3 months and 12 months
Psychological Well-Being Scales (Ryff, 1995)
Measured: Change baseline, 12 weeks, 3 months and 12 months
Change from Well-being at 12 weeks, 3 months and 12 months
Satisfaction with life Scale ( Diener et al. 1985)
Measured: Change baseline, 12 weeks, 3 months and 12 months
Secondary outcomes (6)
Change from Well-beingDistress at 12 weeks, 3 months and 12 months
Hospital Anxiety and Depression Scale (Bjelland et al. 2002)
Measured: Change baseline, 12 weeks, 3 months and 12 months
Change from self-esteem at 12 weeks, 3 months and 12 months
Implicit self-esteem version: Go/No-Go Association Task (Nosek \& Banaji, 2001)
Measured: Change baseline, 12 weeks, 3 months and 12 months
Change from self-esteem at 12 weeks, 3 months and 12 months
Rosenberg self-esteem scale (Rosenberg, 1965)
Measured: Change baseline, 12 weeks, 3 months and 12 months
Change from Attachment at 12 weeks, 3 months and 12 months
Relationship Questionnaire (Bartholomew and Horowitz, 1991)
Measured: Change baseline, 12 weeks, 3 months and 12 months
Change from Paranoid ideation at 12 weeks, 3 months and 12 months
Persecutory Ideation Questionnaire(McKay, Langdon and Coltheart, 2006)
Measured: Change baseline, 12 weeks, 3 months and 12 months
additional Outcome Measures Experience of trauma events
Life Events Checklist for DSM-5 (Gray, 2004)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start10 Oct 2017
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellbeingStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Valiente Ots, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476771
- Sponsor's protocol ID
- ComplutenseMadrid
- Status last verified
- Jul 2020
- First submitted
- 10 Oct 2017
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultivating Well-being Beyond Symptomatology in Subclinical Paranoia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04476771
- Acronym / sponsor ID
- ComplutenseMadrid
- Conditions
- Wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + waiting list | No 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. |
| TAU + Feliz-Mente Intervention | Experimental | Behavioral: Feliz-Mente (third generation psychotherapy)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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Participants with borderline personality disorder
- Participants with substance use disorders and /or
- Participants with severe cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | TAU + Feliz-Mente Intervention |
Primary outcome
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)
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)
6 secondary outcomes
Change from Well-beingDistress at 12 weeks, 3 months and 12 months
Time frame: Change baseline, 12 weeks, 3 months and 12 months
Change from self-esteem at 12 weeks, 3 months and 12 months
Time frame: Change baseline, 12 weeks, 3 months and 12 months
Change from self-esteem at 12 weeks, 3 months and 12 months
Time frame: Change baseline, 12 weeks, 3 months and 12 months
Change from Attachment at 12 weeks, 3 months and 12 months
Time frame: Change baseline, 12 weeks, 3 months and 12 months
Change from Paranoid ideation at 12 weeks, 3 months and 12 months
Time frame: Change baseline, 12 weeks, 3 months and 12 months
additional Outcome Measures Experience of trauma events
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feliz-Mente (third generation psychotherapy) in people with Wellbeing, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Well-being at 12 weeks, 3 months and 12 months (time frame: Change baseline, 12 weeks, 3 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.