Condition category
Mental and Behavioural Disorders
Date applied
28/11/2016
Date assigned
30/11/2016
Last edited
19/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Schizophrenia spectrum disorders (SSD) are a serious mental health problems that affects how a person thinks, feels and behaves. It a causes a range of psychological symptoms, including hallucinations (hearing and/or seeing things) and delusions (believing something that is not true). Impaired social functioning is one of the most characteristic symptoms of SSD and it has been widely described in the literature. Social skills-training (SST) is a well-validated treatment option, and it is recommended in several treatment guidelines for schizophrenia. However, many studies have found that the effects and generalizability of standard SST programs are poorer than desired regarding the benefits on social functioning of patients. For that reason, the main purpose of this study is to analyze the feasibility, effectiveness and potential benefits of a new Metacognition-Oriented Social Skills Training versus conventional SST in outpatients with schizophrenia-spectrum disorders.

Who can participate?
Adults aged 18-65 years with Schizophrenia Spectrum Disorders from two partial hospitals of Navarre, a region located in the north of Spain.

What does the study involve?
Over a period of 30 months eligible participants are invited to participate in this study. Participants finally included are randomly assigned to receive 16 group-sessions with MOSST plus treatment as usual (experimental group), or 16 group-sessions with conventional SST plus treatment as usual (control group). Participants allocated to the experimental group receive 16 weekly sessions of 90 minutes each with MOSST plus treatment as usual (TAU). This involves a group training in conversation skills, assertiveness skills, and conflict management skills. Throughout the MOSST sessions, participants carry out different role-playing exercises aimed at stimulating and developing the capacities to reflect on the thoughts, emotions, and intentions of others. Participants allocated to the control group receive 16 weekly sessions of 90 minutes each with standard SST plus treatment as usual (TAU). This involves a group training of the same social skills of MOSST but not stimulating and developing the metacognitive abilities of participants. At the start of the study and then again after 16 weeks (end of the programs) and six months later, participants in both groups complete a range of questionnaires to assess their mental and social functioning.

What are the possible benefits and risks of participating?
There are no direct benefits or risks of participating.

Where is the study run from?
This study has been set up by the Complejo Hospitalario of Navarre in collaboration with the University of La Rioja.

When is study starting and how long is it expected to run for?
March 2014 to December 2016

Who is funding the study?
1. Complejo Hospitalario of Navarra (Spain)
2. University of La Rioja (Spain)

Who is the main contact?
1. Dr Felix Inchausti
felixinchausti@usal.es
2. Dr Nancy V. Garcia-Poveda
ngarcia@avancesmedicos.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Felix Inchausti

ORCID ID

http://orcid.org/0000-0003-0610-8170

Contact details

Centro de Salud Mental de Ermitagaña
C/ Ermitagaña 20
Planta Baja
Pamplona
31008
Spain
+34 (0)661 120 599
felixinchausti@usal.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NAVARRA_MOSST_2017

Study information

Scientific title

The effects of Metacognition-Oriented Social Skills Training (MOSST) on psychosocial outcomes in schizophrenia-spectrum disorders: a single-blind randomized controlled trial

Acronym

Study hypothesis

The aim of this study is to analyze the feasibility, effectiveness and potential benefits of the Metacognition-Oriented Social Skills Training versus conventional Social Skills Training in outpatients with schizophrenia-spectrum disorders.

Hypotheses:
1. The MOSST intervention provokes larger improvements on social and personal functioning than theconventional SST intervention
2. Only the intervention with MOSST enhances the metacognitive skills of participants

Ethics approval

Assistential and Research Ethics Committee of Benito Menni Hospital (HSC of Navarre), 01/06/2014, ref: 0106/14

Study design

Single-blind randomised controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Schizophrenia spectrum disorders

Intervention

Participants will be randomly assigned (1:1) with permuted block sizes of three or five, to receive MOSST plus TAU (experimental group), or conventional SST plus TAU (control group). Social, occupational and personal functioning, metacognitive abilities and clinical symptoms of participants will be assessed at baseline, post-treatment, and 6-month follow-up.

Experimental group: Participants will receive 16 sessions of MOSST plus treatment as usual (TAU) for 16 weeks. This involves 16-week sessions in which several social skills are targeted. The 16 target social skills have been divided into: (1) conversation skills such as listening to others, greeting others, starting and ending conversations, and maintaining conversations; (2) assertiveness skills such as making and refusing requests, making and receiving compliments, asking for information, suggesting activities to other people, and expressing unpleasant and positive feelings; (3) conflict management skills such as compromise and negotiation, making productive complaints, responding to negative complaints, and making apologies. MOSST employs role-playing exercises that seek to stimulate participants to develop greater capacities to reflect on the thoughts, emotions, and intentions of others. Compared to standard SST, MOSST offers several innovations: (1) MOSST seeks to promote a rich and articulated understanding of mental states necessary to act more effectively in social situations; (2) MOSST focuses on intersubjectivity, and thus, may promote change through thinking about the relationships in which patients and therapists are emotionally involved and contribute in their own way; (3) MOSST encourages therapists to use metacommunication in a technical way that is to speak openly about the mental states that they themselves experience during role-playing exercises with the patient

Control group: Participants will receive 16 sessions of standard SST plus TAU for 16 weeks. This involves 16-week sessions in which the same social skills and role-playing exercises of MOSST are trained but not developing and stimulating the metacognitive abilities of participants.

For both groups, all sessions will last approximately 90 minutes and will adhere to original protocol manuals. Sessions will be conducted by two Clinical Psychologists (doctoral level) with large experience in group therapy and who are versed in standard SST (control group) and metacognitive therapy (experimental group) for schizophrenia.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Metacognitive activity is measured using the Metacognitive Assessment Scale–Abbreviated (MAS-A) at baseline, 16 weeks, and 6 months
2. Social and occupational functioning controlling the influence of the clinical symptoms is measured using the Social and Occupational Functioning Assessment Scale (SOFAS) at baseline, 16 weeks, and 6 months
2. Functioning of patients in four areas independently of symptomatology (socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviors) are measured using the Personal and Social Performance Scale (PSP) at baseline, 16 weeks, and 6 months

Secondary outcome measures

1. Positive and negative symptoms of schizophrenia are measured using the Positive and Negative Syndrome Scale (PANSS) at baseline, 16 weeks, and 6 months
2. Depressive symtoms are measured using the Beck Depression Inventory–II (BDI-II) at baseline, 16 weeks, and 6 months
3. Anxiety is measured using the Beck Anxiety Inventory (BAI) at baseline, 16 weeks, and 6 months

Overall trial start date

01/03/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18–65 years
2. Receiving psychosocial rehabilitation
3. Meet International Classification of Diseases–tenth revision (ICD–10) criteria for schizophrenia, schizoaffective disorder, or delusional disorder, as determined by trained Psychiatrists or Clinical Psychologists through clinical interview
4. Clinically stable
5. Treated with a stable dose of the same antipsychotic in the last 6 months
6. Score at least 4 on PANSS delusions or hallucinations, or at least 5 on suspiciousness or persecution, conceptual disorganization, or grandiosity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

1. Concomitant substance abuse
2. Moderate to severe learning disabilities or developmental disorders
3. Non-Spanish-speaking participants
4. Major neurological illness
5. Impaired intellectual functioning (Wechsler Adult Intelligence Scale–IV Full Scale IQ score < 70)
6. Not having the capacity to consent to research participation

Recruitment start date

01/06/2014

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Spain

Trial participating centre

CRPS Elizondo Benito Menni Hospital
CL Mendinueta S/N, Planta Baja Elizondo-Baztán
Navarra
31700
Spain

Sponsor information

Organisation

Complejo Hospitalario of Navarra

Sponsor details

Centro de Salud Mental de Ermitagaña
C/ Ermitagaña 20
Planta Baja
Pamplona
31008
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Complejo Hospitalario of Navarra

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of La Rioja

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer reviewed journal.

Intention to publish date

30/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28606061

Publication citations

Additional files

Editorial Notes

19/10/2017: Publication reference added.