Clinical trial NCT03275909: Integrated Psychological Therapy for Chronic Schizophrenia
Official title: Integrated Psychological Therapy (IPT) + Emotional Management Therapy (EMT) in Chronic Schizophrenia: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Schizophrenia
Keywords: Chronic schizophrenia
Emotional Management Therapy
Integrated Psychological Therapy
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2017-09-08
Enrollment: 77
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Having ≥ 5 years since disease onset and aged between 25 and 65 years.
2. Being in a stable phase of the illness and under psychopharmacological treatment.
3. Having negative or attenuated positive symptoms.
4. Failing to achieve premorbid functioning in terms of education, work and/or social life.
5. Agreeing to participate in the study and giving written informed consent.

Exclusion Criteria:

* 1. Presenting organic brain pathology. 2. Presenting intellectual developmental disorder according to DSM-5 criteria.

Primary outcomes:
measure: Frankfurt Complaint Questionnaire (FBF-3)
timeFrame: Pretreatment-Posttreatment (8months)-1 month-3 months-6 months-12 months follow-up
Secondary outcomes:
measure: Screen for Cognitive Impairment in Psychiatry (SCIP)
timeFrame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
measure: Wechsler Adult Intelligence Scale-Third Edition (WAIS-III)
timeFrame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
measure: Social Functioning Scale (SFS)
timeFrame: Pretreatment-Posttreatment-1 month (8 months)-3 months-6 months-12 months follow-up
measure: Lancashire Quality of Life Profile (LQoLP)
timeFrame: Pretreatment-Posttreatment (8 months)-1 month-3 months-6 months-12 months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer of School of Psychology
name: Karmele Salaberria, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: