SchizophreniaNCT03261557
Cognitive Behavioral Social Skills Training in Early Onset Psychosis
A study testing CBT + SST and Psychoeducation, habits and healthy lifestyle in people with Schizophrenia and Schizoaffective Disorder, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended psychological interventions to improve symptomatology and functional recovery in psychosis. In addition, CBT may reduce hyperactivation of the brain structures responsible for the stress response. Read more about this study
- Who is it for?
- Ages 12 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Psychosis NOS
- What is being tested?
- CBT + SST and Psychoeducation, habits and healthy lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 22 Feb 2017to 1 Sep 2020
- Phase
- Interventional
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 12 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects with a diagnosis of non-affective psychotic disorder diagnosed between age of 9 and 18 (Schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified according to DSM-V criteria).
- Critical period after the first psychotic episode (which covers the first 5 years) and in non-acute treatment
Who cannot join
- IQ <70
- Toxic dependence comorbid disorder
- Presence of Neurological disorder.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Child and Adolescent Pyshicatry and Psychology
Barcelona, Catalonia, 08036
About this study
Official title: Cognitive Behavioral Social Skills Training in Early-onset Psychosis: Efficacy in Psychotic Symptoms, Psyshosocial Functioning and Neurobiological and Epigenetic Stress Markers.
Cognitive-behavioral therapy (CBT) and social skills training (SST) are recommended psychological interventions to improve symptomatology and functional recovery in psychosis. In addition, CBT may reduce hyperactivation of the brain structures responsible for the stress response. In patients with early onset psychotic disorder (EOP) there are not any previous controlled study that has analyzed the efficacy of this type of intervention.
The aim of this study is to investigate efficacy of CBT + SST in symptomatic and functional improvement after the treatment in patients with EOP. The study will also examine the potential effect of the intervention on neurobiological stress markers.
Read the detailed description
Early-onset of psychotic disorders (EOP), and especially Schizophrenia, is associated with a worse clinical and psychosocial evolution than in the adult form of the illness. In the case of patients with EOP, international and national clinical guidelines recommend the combination of pharmacological treatment with CBT. However there are not any previous controlled study that has analyzed the efficacy of this type of psychological intervention.
A controlled randomized study will be carry out of CBT + SST intervention compared to a control intervention of the same duration, format and contact with a therapist. The sample will be 30 participants with a diagnosis of schizophrenia, Schizoaffective disorder or psychotic disorder not otherwise specified diagnosed between 9 and 18 years. Patiens have to be in the early phase of the disease (first 5 years after the onset) and in non-acute treatment. All participants will be evaluated before and after the intervention with clinical scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age, puberal stage and sex will be also recruited and evaluated only at baseline point. The evaluations will be carried out by blind evaluators. Intention-to-treat analysis will be carry out using the statistical package SPSS v 20.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychosis NOS
- Being tested
- CBT + SST, Psychoeducation, habits and healthy lifestyle
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT + SSTBehavioural
It will consist of 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: cognitive skills module, which includes the basic principles of CBT for psychosis; Social skills module, which includes the usual strategies in HHSS training; and problem solving module.
All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.
Psychoeducation, habits and healthy lifestyleBehavioural
Patients randomized to the control treatment will receive the same number of Individual and group sessions, with the same periodicity and format: 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: psychoeducation, habits and healthy lifestyle.
All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual.
| Study group | Role | What they receive |
|---|---|---|
| CBT + SST | Experimental | The treatment group will receive the intervention according to the CBSST protocol, adapted to adolescents. Receives: Behavioral: CBT + SST |
| Psychoeducation, habits and healthy lifestyle | Active comparator | The control group will receive 3 modules intervention: psychoeducation, habits and healthy lifestyle. Receives: Behavioral: Psychoeducation, habits and healthy lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial functioning
Change from baseline in social functioning questionnaires
Measured: 15 weeks
Clinical symptoms
Change from baseline in Clinical scales
Measured: 15 weeks
Secondary outcomes (2)
Biological stress markers
Change pre-post interventionbiological stress markers registered by blood analyses
Measured: 15 weeks
Subjective stress
Change pre-post intervention in questionnaires of perceived stress
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start22 Feb 2017
- Primary completion1 Feb 2020
- Study completion1 Sep 2020
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Olga Puig, Hospital Clinic of Barcelona
- Investigators
- Olga Puig, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261557
- Sponsor's protocol ID
- DN040595
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2017
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No