A mindfulness-based therapy to improve social functioning of people with severe mental illness

Mindfulness and Acceptance-Based therapy for social functioning improvement in people experiencing persistent psychotic experiences: a randomized controlled clinical trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88244543

Enrollment

120

Registered

2024-11-16

Start date

2024-12-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improvement of social functioning of people diagnosed with severe mental illness Mental and Behavioural Disorders

Interventions

The project will use a pragmatic, controlled, randomized clinical trial, with pre-treatment, post-treatment, and follow-up assessments at 6 and 12 months after the end of the intervention. Procedure

and 2) Group-based psychoeducation, consisting of 18 weekly one-hour sessions focusing on managing SMI, strategies for preventing relapse and managing conflict, as well as social skills training with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age over 18 years 2. Diagnosis, according to clinical history, based on the DSM-5 criteria for Schizophrenia Spectrum and Other Psychotic Disorders or Bipolar disorder with psychotic features 3. No hospitalization for acute psychotic symptoms in the past month 4. Proficiency in understanding Spanish 5. Provision of informed consent, either by the participant or their legal guardian

Exclusion criteria

Exclusion criteria: 1. Presence of psychotic symptoms due to an organic condition 2. Inability to attend intervention sessions 3. Presence of a degenerative, severe infectious disease, or other neurological condition 4. Refusal to sign the informed consent by the participant or their legal guardian

Design outcomes

Primary

Measure	Time frame
Social functioning measured using the Personal and Social Performance scale (PSP) at pre-treatment, post-treatment, and 6 and 12 months after the end of the intervention	—

Secondary

Measure	Time frame
The following secondary outcome measures are assessed at baseline, post-treatment, 6 months and 12 months follow-up 1. Frequency and intensity of psychotic symptoms measured using the Positive and Negative Syndrome Scale (PANSS) interview 2. Relationship with positive psychotic symptoms measured using the Psychotic Symptom Rating Scales (PSYRATS) interview 3. Blunted affect, alogia, asociality, anhedonia, and avolition measured through the Brief Negative Symptom Scale (BNSS) 4. Depression symptoms measured with the Calgary Depression Scale (CDS) 5. Dispositional mindfulness measured using the Mindful Attention Awareness Scale (MAAS) Added 18/07/2025: 6. Psychological flexibility assessed using the comprehensive assessment of Acceptance and Commitment Therapy processes (compACT) at baseline, post-treatment, 6 months and 12 months follow-up	—

Measure

Time frame

The following secondary outcome measures are assessed at baseline, post-treatment, 6 months and 12 months follow-up 1. Frequency and intensity of psychotic symptoms measured using the Positive and Negative Syndrome Scale (PANSS) interview 2. Relationship with positive psychotic symptoms measured using the Psychotic Symptom Rating Scales (PSYRATS) interview 3. Blunted affect, alogia, asociality, anhedonia, and avolition measured through the Brief Negative Symptom Scale (BNSS) 4. Depression symptoms measured with the Calgary Depression Scale (CDS) 5. Dispositional mindfulness measured using the Mindful Attention Awareness Scale (MAAS) Added 18/07/2025: 6. Psychological flexibility assessed using the comprehensive assessment of Acceptance and Commitment Therapy processes (compACT) at baseline, post-treatment, 6 months and 12 months follow-up

—

Countries

Spain

Contacts

Public ContactEmilio López-Navarro

emilio.lopez@uib.es+34 971173130

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026