Chronic SchizophreniaNCT03275909
Integrated Psychological Therapy for Chronic Schizophrenia
A study testing Integrated Psychological Therapy in people with Chronic Schizophrenia, run by University of the Basque Country (UPV/EHU).
Trial summary
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people think, feel and act, underlines the need for effective interventions in patients affected by this disorder. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Schizophrenia
- What is being tested?
- Integrated Psychological Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2011to 31 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having ≥ 5 years since disease onset and aged between 25 and 65 years.
- Being in a stable phase of the illness and under psychopharmacological treatment.
- Having negative or attenuated positive symptoms.
- Failing to achieve premorbid functioning in terms of education, work and/or social life.
- Agreeing to participate in the study and giving written informed consent.
Who cannot join
- 1. Presenting organic brain pathology. 2. Presenting intellectual developmental disorder according to DSM-5 criteria.
About this study
Official title: Integrated Psychological Therapy (IPT) + Emotional Management Therapy (EMT) in Chronic Schizophrenia: Study Protocol for a Randomized Controlled Trial
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people think, feel and act, underlines the need for effective interventions in patients affected by this disorder. The Integrated Psychological Therapy appears in clinical practice guidelines as the reference therapy in the treatment of this type of patients. In this paper authors propose to include in this program a new module focused on Emotional Management Therapy in order to reinforce its effectiveness. The aim of this study is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of this modified IPT program in patients with CS compared to treatment as usual (pharmacological treatment and social and leisure activities in a Day Care Center).
Methods/design: This is a randomized study with pre and post-treatment assessment and with a 6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1) a experimental group: integrated psychological therapy in conjunction with emotional management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in addition to the treatment as usual (TAU), or (2) a control group (treatment as usual). Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment after 8 months. The primary outcome will be that patients in the experimental group will show a greater improvement over participants in the control group in reducing symptoms and increasing emotional abilities, as well as in improving their quality of life. The secondary outcome will be that these results will maintain at the 6- and 12-month follow-up in the experimental group.
Read the detailed description
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people think, feel and act, underlines the need for effective interventions in patients affected by this disorder. The Integrated Psychological Therapy (IPT) appears in clinical practice guidelines as the reference therapy in the treatment of this type of patients. In this paper authors propose to include in this program a new module focused on Emotional Management Therapy (EMT) in order to reinforce its effectiveness. The aim of this study is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of this modified IPT program in patients with CS compared to treatment as usual (pharmacological treatment and social and leisure activities in a Day Care Center).
Methods/design: This is a randomized study with pre and post-treatment assessment and with a 6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1) a experimental group: integrated psychological therapy in conjunction with emotional management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in addition to the treatment as usual (TAU), or (2) a control group (treatment as usual). Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment after 8 months. The primary outcome will be that patients in the experimental group will show a greater improvement over participants in the control group in reducing symptoms and increasing emotional abilities, as well as in improving their quality of life. The secondary outcome will be that these results will maintain at the 6- and 12-month follow-up in the experimental group.
Discussion: This study provides the description of a clinical trial based on specific psychological intervention (IPT+EMT) for patients with chronic schizophrenia, aiming to improve lasting clinical and functional outcome.
- Conditions
- Chronic Schizophrenia
- Being tested
- Integrated Psychological Therapy
- Keywords
- Chronic schizophrenia, Emotional Management Therapy, Integrated Psychological Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Psychological TherapyBehavioural
Also called Emotional Management Therapy
The psychological treatment includes 50 sessions of integrated psychological therapy focused on attentional skills, social perception skills, verbal communication skills, social skills and interpersonal problems solving skills and 10 sessions of specific emotional management therapy , designed for this research. and based on the contents developed by Hodel, Kern and Brenner
| Study group | Role | What they receive |
|---|---|---|
| Study procedure | Experimental | An experimental group the psychological treatment includes 50 sessions of integrated psychological therapy (IPT) (focused on attentional skills training, social perception skills training, verbal communication skills, social skills training, interpersonal problems solving skills) and 10 sessions of specific emotional management therapy (EMT), designed for this research and based on the contents developed by Hodel, Kern and Brenner. Receives: Behavioral: Integrated Psychological Therapy |
| Treatment as usual | No intervention | The treatment as usual is pharmacological treatment and activities in a Day Care Center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frankfurt Complaint Questionnaire (FBF-3)
(Assessing change)This is a self-report test composed of 98 items measuring the presence of the "basic" symptoms of schizophrenia. These are subjectively experienced disturbances at different domains including perception, thought, processing, language and attention that it could be the neurobiological features of schizophrenia. It contains 10 subscales and 4 factors. We will use a validated version for the Spanish population, in which Cronbach's alpha was above .95 and the test-retest reliability was above .60
Measured: Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up
Secondary outcomes (5)
Screen for Cognitive Impairment in Psychiatry (SCIP)
(Assessing change)This test assesses cognitive impairment through five areas: immediate and delayed verbal learning, working memory, verbal fluency and information processing speed. It is used for identifying cognitive impairment. The test-retest reliability ranged from 74 to 90 and Cronbach's alpha was 73.
Measured: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)
(Assessing change)Short forms of this scale have been designed for patients with schizophrenia . It assess cognitive functioning. Scores on these short forms are correlated (0.91) with the overall intelligence quotient (IQ) of the full scale in clinical patients.
Measured: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Wisconsin Card Sorting Test (WCST)
(Assessing change)This test assesses attention span, planning and execution, and hence is considered a valid measure of executive function. We used the version of the test standardised and benchmarked for the Spanish population by TEA Editions.
Measured: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Social Functioning Scale (SFS)
(Assessing change)We will use the short version of the scale, validated in a Spanish clinical sample, with a Cronbach's alpha of 0.76.
Measured: Pretreatment-Posttreatment-1 month (8 months)-3 months-6 months-12 months follow-up
Lancashire Quality of Life Profile (LQoLP)
(Assessing change)This instrument assesses patient satisfaction with various aspects of their life, work, leisure time, religion, finances, living situation, safety, family relations, social relations, and health, as well as global wellbeing and self-esteem.
Measured: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Jul 2011
- Primary completion30 Jul 2013
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Karmele Salaberria Irizar, University of the Basque Country (UPV/EHU)
- Investigators
- Karmele Salaberria, Ph.D, Principal investigator, Lecturer of School of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275909
- Sponsor's protocol ID
- PSI2011-27590
- Status last verified
- Sep 2017
- First submitted
- 10 Jul 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: to share the study protocol and the clinical study report
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Psychological Therapy (IPT) + Emotional Management Therapy (EMT) in Chronic Schizophrenia: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03275909
- Acronym / sponsor ID
- PSI2011-27590
- Conditions
- Chronic Schizophrenia
- Keywords
- Chronic schizophrenia, Emotional Management Therapy, Integrated Psychological Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 30 Jul 2013 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people think, feel and act, underlines the need for effective interventions in patients affected by this disorder. The Integrated Psychological Therapy appears in clinical practice guidelines as the reference therapy in the treatment of this type of patients. In this paper authors propose to include in this program a new module focused on Emotional Management Therapy in order to reinforce its effectiveness. The aim of this study is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of this modified IPT program in patients with CS compared to treatment as usual (pharmacological treatment and social and leisure activities in a Day Care Center).
Methods/design: This is a randomized study with pre and post-treatment assessment and with a 6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1) a experimental group: integrated psychological therapy in conjunction with emotional management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in addition to the treatment as usual (TAU), or (2) a control group (treatment as usual). Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment after 8 months. The primary outcome will be that patients in the experimental group will show a greater improvement over participants in the control group in reducing symptoms and increasing emotional abilities, as well as in improving their quality of life. The secondary outcome will be that these results will maintain at the 6- and 12-month follow-up in the experimental group.
Detailed description
Background: The chronic phase of schizophrenia (CS) that extremely affects the way people think, feel and act, underlines the need for effective interventions in patients affected by this disorder. The Integrated Psychological Therapy (IPT) appears in clinical practice guidelines as the reference therapy in the treatment of this type of patients. In this paper authors propose to include in this program a new module focused on Emotional Management Therapy (EMT) in order to reinforce its effectiveness. The aim of this study is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of this modified IPT program in patients with CS compared to treatment as usual (pharmacological treatment and social and leisure activities in a Day Care Center).
Methods/design: This is a randomized study with pre and post-treatment assessment and with a 6- and 12-month follow-up. Patients are to be randomly assigned to one of two treatments: (1) a experimental group: integrated psychological therapy in conjunction with emotional management therapy (IPT+EMT), composed of 2-hour biweekly 60 group sessions for 32 weeks, in addition to the treatment as usual (TAU), or (2) a control group (treatment as usual). Participants in both groups will be evaluated at baseline (pre-treatment) and at post-treatment after 8 months. The primary outcome will be that patients in the experimental group will show a greater improvement over participants in the control group in reducing symptoms and increasing emotional abilities, as well as in improving their quality of life. The secondary outcome will be that these results will maintain at the 6- and 12-month follow-up in the experimental group.
Discussion: This study provides the description of a clinical trial based on specific psychological intervention (IPT+EMT) for patients with chronic schizophrenia, aiming to improve lasting clinical and functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study procedure | Experimental | Behavioral: Integrated Psychological TherapyAn experimental group the psychological treatment includes 50 sessions of integrated psychological therapy (IPT) (focused on attentional skills training, social perception skills training, verbal communication skills, social skills training, interpersonal problems solving skills) and 10 sessions of specific emotional management therapy (EMT), designed for this research and based on the contents developed by Hodel, Kern and Brenner. |
| Treatment as usual | No intervention | –The treatment as usual is pharmacological treatment and activities in a Day Care Center. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having ≥ 5 years since disease onset and aged between 25 and 65 years.
- Being in a stable phase of the illness and under psychopharmacological treatment.
- Having negative or attenuated positive symptoms.
- Failing to achieve premorbid functioning in terms of education, work and/or social life.
- Agreeing to participate in the study and giving written informed consent.
Key exclusion criteria (1 listed)
- 1. Presenting organic brain pathology. 2. Presenting intellectual developmental disorder according to DSM-5 criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Psychological TherapyAlso: Emotional Management TherapyThe psychological treatment includes 50 sessions of integrated psychological therapy focused on attentional skills, social perception skills, verbal communication skills, social skills and interpersonal problems solving skills and 10 sessions of specific emotional management therapy , designed for this research. and based on the contents developed by Hodel, Kern and Brenner | Behavioural | Study procedure |
Primary outcome
Frankfurt Complaint Questionnaire (FBF-3)
Time frame: Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up
(Assessing change)This is a self-report test composed of 98 items measuring the presence of the "basic" symptoms of schizophrenia. These are subjectively experienced disturbances at different domains including perception, thought, processing, language and attention that it could be the neurobiological features of schizophrenia. It contains 10 subscales and 4 factors. We will use a validated version for the Spanish population, in which Cronbach's alpha was above .95 and the test-retest reliability was above .60
5 secondary outcomes
Screen for Cognitive Impairment in Psychiatry (SCIP)
Time frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)
Time frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Wisconsin Card Sorting Test (WCST)
Time frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Social Functioning Scale (SFS)
Time frame: Pretreatment-Posttreatment-1 month (8 months)-3 months-6 months-12 months follow-up
Lancashire Quality of Life Profile (LQoLP)
Time frame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Individual participant dataSharing planned: Yes. to share the study protocol and the clinical study report
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karmele Salaberria, Ph.D principal investigator
Lecturer of School of Psychology
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Psychological Therapy in people with Chronic Schizophrenia, run by University of the Basque Country (UPV/EHU).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frankfurt Complaint Questionnaire (FBF-3) (time frame: Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.