Effectiveness of a Mindfulness-based Group Training Addressing Social Cognition in First Episode Psychosis (AGES-Mind)
- Conditions
- Psychotic EpisodeSchizophrenia and Disorders With Psychotic Features
- Interventions
- Behavioral: Psychoeducational multicomponent interventionBehavioral: SocialMINDBehavioral: Psychosocial treatmentDrug: Psychotropic treatment
- Registration Number
- NCT03309475
- Brief Summary
The current investigation aims to compare two group intervention in patients with a first episode of psychosis, that is, people who have suffered their first psychotic episode within 5 years prior to their inclusion in the study. The experimental arm is a mindfulness-based social cognition training (SocialMind) designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. The active comparator arm is a psychoeducation program specifically designed for individuals with recent onset psychosis by members of the team with great experience in delivering such interventions. The main outcome is social functioning, as measured by the Personal and Social Performance Scale (PSP), an instrument developed for psychotic patients. The main hypothesis is that the improvement in social functioning will be larger among the participants on the experimental arm, because there is enough evidence suggesting that deficits in social cognition are present even in the first stages of psychotic syndrome and related to social functioning and general disability. Moreover, mindfulness-based interventions have proven themselves effective in other severe mental disorders.
- Detailed Description
Social functioning is impaired among many patients with a first episode of psychosis, who also show a lower ability to recognize, understand and benefit from social stimuli (i.e., deficits in social cognition) than their pairs. Both deficits underlie the general functional impairment found across non-affective psychotic syndromes. Since currently available pharmacological strategies have not proven themselves effective in addressing this matter, new psychotherapeutic approaches should be developed. Investigators' main hypothesis is that a mindfulness-based social cognition group training (SocialMind) will improve social and general functioning, and that this improvement will be higher in the SocialMind than in the psychoeducation group. Given the association between oxidative stress and cognitive functioning, a relationship between oxidative stress biomarkers and intervention-related variables is also expected.
A research team with more than ten mental health professionals and many collaborators will carry and oversee the assessment sessions. A Pharmacology Department will analyse the biological samples. Regulated-trained, well-experienced clinicians will design and administer both interventions. The whole team will take part in the process of scientific publication and results dissemination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 18-45 years old
- First hospitalization, first visit to mental health services with positive symptoms, onset of antipsychotic treatment, or first appearance of positive symptoms confirmed by an informant within the period of five years prior to the enrolment in the study;
- Informed consent given
- Clinical Global Impression (CGI) higher than 5 ("markedly ill")
- Other Axis I diagnoses, except for substance use if psychotic symptoms remain at least 14 days after negative urine test.
- Intellectual disability plus impaired global functioning prior to disorder onset
- Generalized development disorder
- Pregnancy
- Attendance to either mindfulness programs or structured psychoeducational interventions at the time of the enrolment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychoeducational Multicomponent Intervention Psychosocial treatment The active comparator arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and a psychoeducational multicomponent intervention for psychosis.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 7 monthly sessions. Psychoeducational Multicomponent Intervention Psychoeducational multicomponent intervention The active comparator arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and a psychoeducational multicomponent intervention for psychosis.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 7 monthly sessions. SocialMIND SocialMIND 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. SocialMIND Psychosocial treatment 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. SocialMIND Psychotropic treatment 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. Psychoeducational Multicomponent Intervention Psychotropic treatment The active comparator arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and a psychoeducational multicomponent intervention for psychosis.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 7 monthly sessions.
- Primary Outcome Measures
Name Time Method Change in social functioning 8, 16, 36 and 48 weeks Personal and Social Performance Scale (PSP) measures patient's functioning on different social areas, such as self-care, relationships, social activities and aggressive behavior.
- Secondary Outcome Measures
Name Time Method Change in clinical global impression 8, 16, 36 and 48 weeks Clinical Global Impression Scale for Schizophrenia (CGI-SCH) measures patients' clinical state and clinical change over time
Change in quality of life 8, 16, 36 and 48 weeks WHOQOL-BREF measures patient's quality of life according to World Health Organization parameters.
Change in social cognition 8, 16, 36 and 48 weeks Hinting task, Reading the Mind in the Eyes Test (RMET), Emotion Recognition task (ER-40) and Ambiguous Intentions and Attribution Questionnaire (AIHQ) measure main domains of social cognition.
Change in depressive symptoms 8, 16, 36 and 48 weeks Calgary Depression Scale for Schizophrenia (CDSS) measures depressive symptoms in psychotic patients through a personal interview
Change in mindful attention and awareness 8, 16, 36 and 48 weeks Mindfulness Attention Awareness Scale (MAAS) measures processes thought to be related to clinical outcomes in mindfulness-based interventions.
Change in global functioning 8, 16, 36 and 48 weeks Global Assessment of Functioning Scale (GAF) measures patient's general functioning using a single 0-100 scale.
Change in reflective functioning 8, 16, 36 and 48 weeks Reflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions
Change in oxidative stress and anti-inflammatory response 8 and 48 weeks Total antioxidant status, enzymatic activity and cytokines
Change in emotional intelligence 8, 16, 36 and 48 weeks Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT v2.0) measures emotional intelligence through a set of questions referred to different situations.
Change in psychotic symptoms 8, 16, 36 and 48 weeks Positive and Negative Symptoms Scale for Schizophrenia (PANSS) measures psychotic syndrome through a detailed clinical interview.
Change in anxiety symptoms 8, 16, 36 and 48 weeks Beck Anxiety Inventory (BAI) measures clinical anxiety through 21 items.
Change in neurocognition 8, 16, 36 and 48 weeks Four tasks of the Matrics Consensus Cognitive Battery (MCCB) measure different domains of neurocognition (symbol coding, letter number span, spatial span and CPT-IP)
Change in cognitive insight 8, 16, 36 and 48 weeks Beck Cognitive Insight Scale (BCIS) explores self-reflection and self-certainty, as parts of the cognitive insight construct
Trial Locations
- Locations (1)
La Paz University Hospital
🇪🇸Madrid, Spain