SchizophreniaACAMP2020NCT04144075
Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.
A study testing Mindful Self-Compassion Program, Cognitive Behaviour Therapy Group and Treatment as usual in people with Schizophrenia, run by Gutiérrez-Hernández, ME.
Trial summary
This is a randomized clinical trial to check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Mindful Self-Compassion Program, Cognitive Behaviour Therapy Group and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 15 Feb 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizohrenia
Who cannot join
- Drug addict
Trial locations and contacts
No sites are listed yet.
About this study
This is a randomized clinical trial to check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme.
Read the detailed description
MAIN AIM To check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme, compared with those participating in an active control programme or those following usual treatment.
DESIGN
Randomized clinical trial, three parallel groups:
- Experimental, which will receive the MSC together with the usual treatment (TAU).
- Active control, which will receive an alternative programme with cognitive, behavioural and psychoeducational components (CBTG) together with the TAU.
- Passive control, which will receive the TAU. STUDY DISORDER
Schizophrenia. DATA FROM THE INTERVENTION UNDER STUDY Program developed by Kristin Neff and Christopher Germer, after observing in diverse investigations the inverse correlation between levels of self-pity and diverse pathological clinical variables.
POPULATION UNDER STUDY Patients from Telde's Mental Health Unit who have been diagnosed with schizophrenia.
TOTAL NUMBER OF SUBJECTS 150
- Conditions
- Schizophrenia
- Being tested
- Mindful Self-Compassion Program, Cognitive Behaviour Therapy Group, Treatment as usual
- Keywords
- Psychosis, Quality of life, Mindfulness, Compassion, Self-compassion, Schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Self-Compassion ProgramBehavioural
Also called CSM
It is a protocolized training program in mindfulness and self-compassion skills. It has a duration of 8 weekly group sessions of about two hours and 45 minutes and a silent retreat of 4 hours.
Cognitive Behaviour Therapy GroupBehavioural
Also called CBTG
It is a control intervention designed for the development of a control group suitable for comparison with experimental groups.
Treatment as usualOther
Also called TAU
It is variable according to the clinical and personal characteristics of the patient, the most common components will be described.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Self-Compassion | Experimental | Protocolized training program in mindfulness and self-compassion skills. Receives: Behavioral: Mindful Self-Compassion Program |
| Cognitive Behaviour Therapy Group | Active comparator | A control intervention designed to develop a control group suitable for comparison with experimental groups receiving interventions based on mindfulness and compassion. Receives: Behavioral: Cognitive Behaviour Therapy Group |
| Treatment as Usual | Placebo comparator | Es variable según las características clínicas y personales del paciente. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Instument. WHOQOL-BREF
Scores from 5 to 130, the higher score the worse outcome.
Measured: 15 minutes
Secondary outcomes (1)
Self-compassion scale (SCS)
Scores from 5 to 130, the higher score the worse outcome
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 May 2020 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gutiérrez-Hernández, ME
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gutiérrez-Hernández, ME, Complejo Hospitalario Universitario Insular Materno Infantil
- Investigators
- Alicia Díaz Megolla, Study director, Universidad de Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144075
- Sponsor's protocol ID
- 2019-434-1
- Acronym
- ACAMP2020
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Mindfulness and Self-Compassion Program in Patients With Schizophrenia. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04144075
- Acronym / sponsor ID
- ACAMP2020 / 2019-434-1
- Conditions
- Schizophrenia
- Keywords
- Psychosis, Quality of life, Mindfulness, Compassion, Self-compassion, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gutiérrez-Hernández, MEUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 30 Oct 2019 (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.
This is a randomized clinical trial to check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme.
Detailed description
MAIN AIM To check whether the quality of life of patients with schizophrenia improves after participation in the mindfulness and self-compassion (MSC) programme, compared with those participating in an active control programme or those following usual treatment.
DESIGN
Randomized clinical trial, three parallel groups:
- Experimental, which will receive the MSC together with the usual treatment (TAU).
- Active control, which will receive an alternative programme with cognitive, behavioural and psychoeducational components (CBTG) together with the TAU.
- Passive control, which will receive the TAU. STUDY DISORDER
Schizophrenia. DATA FROM THE INTERVENTION UNDER STUDY Program developed by Kristin Neff and Christopher Germer, after observing in diverse investigations the inverse correlation between levels of self-pity and diverse pathological clinical variables.
POPULATION UNDER STUDY Patients from Telde's Mental Health Unit who have been diagnosed with schizophrenia.
TOTAL NUMBER OF SUBJECTS 150
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindful Self-Compassion | Experimental | Behavioral: Mindful Self-Compassion ProgramProtocolized training program in mindfulness and self-compassion skills. |
| Cognitive Behaviour Therapy Group | Active comparator | Behavioral: Cognitive Behaviour Therapy GroupA control intervention designed to develop a control group suitable for comparison with experimental groups receiving interventions based on mindfulness and compassion. |
| Treatment as Usual | Placebo comparator | Other: Treatment as usualEs variable según las características clínicas y personales del paciente. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of schizohrenia
Key exclusion criteria (1 listed)
- Drug addict
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 |
|---|---|---|
| Mindful Self-Compassion ProgramAlso: CSMIt is a protocolized training program in mindfulness and self-compassion skills. It has a duration of 8 weekly group sessions of about two hours and 45 minutes and a silent retreat of 4 hours. | Behavioural | Mindful Self-Compassion |
| Cognitive Behaviour Therapy GroupAlso: CBTGIt is a control intervention designed for the development of a control group suitable for comparison with experimental groups. | Behavioural | Cognitive Behaviour Therapy Group |
| Treatment as usualAlso: TAUIt is variable according to the clinical and personal characteristics of the patient, the most common components will be described. | Other | Treatment as Usual |
Primary outcome
World Health Organization Quality of Life Instument. WHOQOL-BREF
Time frame: 15 minutes
Scores from 5 to 130, the higher score the worse outcome.
1 secondary outcome
Self-compassion scale (SCS)
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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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.
Alicia Díaz Megolla study director
Universidad de Las Palmas de Gran Canaria
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Self-Compassion Program, Cognitive Behaviour Therapy Group and Treatment as usual in people with Schizophrenia, run by Gutiérrez-Hernández, ME.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Elena F Gutiérrez-Hernández (658024211, benchara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life Instument. WHOQOL-BREF (time frame: 15 minutes). 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 4 Nov 2019.