NCT03434405

Brief Summary

The current investigation has been designed to test the feasibility of a mindfulness-based social cognition training (SocialMind) for people with a first episode of psychosis (AGES-Mind Study, NCT03309475). The intervention has been designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. Main outcomes are recruitment rate, adverse events and treatment adherence, although therapy effects and adjustment to intervention manual are also explored.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

February 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 15, 2019

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

February 2, 2018

Last Update Submit

February 12, 2019

Conditions

Schizophrenia and Disorders With Psychotic FeaturePsychotic Episode

Keywords

schizophreniamindfulnesssocial cognitionSocialMindAGES-Mind

Outcome Measures

Primary Outcomes (1)

  • Recruitment rate

    At least 25 participants meeting inclusion criteria

    0 weeks

Secondary Outcomes (14)

  • Attrition rate

    8 weeks

  • Change in Psychiatric Symptoms

    8 weeks

  • Change in dissociative Symptoms

    8 weeks

  • State anxiety

    8 weeks

  • Participants' satisfaction

    8 weeks

  • +9 more secondary outcomes

Other Outcomes (1)

  • Clinician's adjustment to treatment protocol

    8 weeks

Study Arms (1)

SocialMind

EXPERIMENTAL

The experimental arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team. There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 5 monthly sessions.

Behavioral: SocialMindBehavioral: Psychosocial treatmentDrug: Psychotropic treatment

Interventions

SocialMindBEHAVIORAL

SocialMind is a mindfulness-based intervention including elements such as radical acceptance, decentering or meditation-techniques. It is designed to target social cognition, defined as the ability to recognize, understand and benefit from social stimuli.

Also known as: Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCT
SocialMind
Psychosocial treatmentBEHAVIORAL

Treatment as usual delivered by patient's practitioner

SocialMind
Psychotropic treatmentDRUG

Treatment as usual delivered by patient's practitioner

SocialMind

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Diagnosis of psychotic disorder according to DSM-5 and history of more than five years of psychotic symptoms
  • CGI-SCH equal or lower than four points ("moderately ill")
  • Informed consent given

You may not qualify if:

  • Intellectual disability plus impaired global functioning prior to disorder onset
  • Generalized development disorder
  • Substance related disorders (except for nicotine) according to DSM-5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Paz University Hospital

Madrid, 28045, Spain

Location

Related Publications (2)

  • Cramer H, Lauche R, Haller H, Langhorst J, Dobos G. Mindfulness- and Acceptance-based Interventions for Psychosis: A Systematic Review and Meta-analysis. Glob Adv Health Med. 2016 Jan;5(1):30-43. doi: 10.7453/gahmj.2015.083. Epub 2016 Jan 1.

    PMID: 26937312BACKGROUND

  • Mediavilla R, Munoz-Sanjose A, Rodriguez-Vega B, Bayon C, Lahera G, Palao A, Bravo-Ortiz MF. Mindfulness-Based Social Cognition Training (SocialMind) for People With Psychosis: A Feasibility Trial. Front Psychiatry. 2019 May 2;10:299. doi: 10.3389/fpsyt.2019.00299. eCollection 2019.

    PMID: 31118909DERIVED

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Maria Fe Bravo, MD, PhD

    Instituto para la Investigación Biomédica del Hospital Universitario La Paz [La Paz University Hospital Biomedical Research Institute]

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Multi-center, open-label, prospective, non-randomized, single-group, clinical trial. The experimental arm will receive TAU (both drug and psychosocial therapy) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 15, 2018

Study Start

February 25, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

February 15, 2019

Record last verified: 2018-01

Locations

ES(1)