- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04031560
Effects of an Integrative Psychological Program in Bipolar Disorder
Effects of an Integrative Program Combining Mindfulness-based Cognitive Therapy, Psychoeducation and Functional Remediation in Bipolar Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design: Single-blind randomized control trial.
Participants: Study participants will be enrolled from the Bipolar Disorders Program of the Hospital Clinic of Barcelona (Spain) and the Bipolar Disorders Unit.
Procedure: At baseline, the sample will be evaluated with respect to sociodemographic, clinical and neuropsychological variables. Subsequently, patients will be randomly assigned (1:1) to two different groups. The experimental group (62 patients) will take part on the integrative group program consisting of 12-sessions, 90 minutes each, once a week (4 focused on psychoeducation, 1 directed to the family relatives, 3 on mindfulness and 4 on functional remediation) whilst the control group (62 patients) will not receive any type of add-on psychotherapy. All the patients will maintain a standard psychiatric treatment during the study. Together with the baseline assessment, the whole sample will be assessed after the intervention and at the 12 months of follow-up. Psychiatric medication will be recorded during the follow-up and the reasons for eventual modifications. All the subjects will be evaluated by researchers blinded to the treatment condition. Semi-structured interviews will be conducted and complemented with clinical records and with assessment instruments to collect variables related to the course of the illness. This study will be conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice and approved by the Hospital Clinic Ethics and Research. All participants will be asked to provide written informed consent prior to their inclusion in the study.
Variables assessed:
- Demographic variables: gender, age, marital status, educational status and work situation.
- Clinical variables: age at the onset of BD, age at first hospitalization, total number and type of previous episodes, hospitalizations, history of psychotic symptoms, polarity of the first episode, seasonal pattern, presence of rapid cycling, bipolar subtype (I or II), comorbidities, familial psychiatric history, familial history of affective disorder, familial history of complete suicide, previous suicide attempts, number of attempts, method and medical severity of attempts, history of drug use.
- Clinical scales: Temperament Evaluation of the Memphis, Pisa, Paris, and San Diego Autoquestionnaire (TEMPS-A, Akiskal et al, 2005), Barratts Impulsiveness Scale (BIS-11, Barratt et al, 1983), Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN, Rosa et al., 2007), and Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA, Rosa et al., 2013).
- Psychosocial functioning: Functional assessment short test (FAST, Rosa et al., 2007).
- Wellbeing and quality of life: WHO (Five) Well Being Index (WHO, 1998), Quality of Life in Bipolar Disorder scale (QoL.BD, Michalak y Murray, 2010).
- Scales of mindfulness: Five Facet Mindfulness Questionnaire (FFMQ, Baer et al., 2006), Mindful Attention Awareness Scale (MAAS, Brown y Ryan, 2003).
- Neuropsychological assessment: WAIS-IV (Wechsler, 2012), with the following subtests: vocabulary, arithmetic, digit span, letter-number sequencing, symbol search, coding; Wisconsin Card Sorting Test (WCST, Heaton et al, 1981); Stroop Color-Word Interference Test (Golden y col., 1995); F-A-S Verbal Phonemic Fluency Test (Benton & Hamser, 1978); Trail Making Test (TMT, Reitan y Wolfson, 1985); Continuous Performance Test (CPT-III, Conners 2014); California Verbal Learning Test (CVLT-II, Delis et al, 2000); Rey-Osterrieth Complex Figure Test (Osterreith, 1944; Rey, 1941); the Mayer- Salovey-Caruso Emotional Intelligence Test (MSCEIT, Mayer et al., 2003) and the Iowa Gambling Test (IGT, Bechara et al, 1994).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jose Sanchez-Moreno, PhD
- Phone Number: 4179 +34932275400
- Email: jose.sanchez.moreno@cibersam.es
Study Contact Backup
- Name: Anabel Martinez Aran
- Phone Number: 4179 +34932275400
- Email: amartiar@clinic.cat
Study Locations
-
-
-
Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic of Barcelona
-
Contact:
- Jose Sanchez-Moreno
- Email: jose.sanchez.moreno@cibersam.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosis of BD type I or II according to DSM-5 criteria
- euthymic or with subthreshold symptoms (HDRS <14; YMRS <8)
- absence of an acute mood episode in the 3 months prior to the beginning of the intervention
Exclusion Criteria:
- estimated Intelligence Quotient (IQ) lower than 85,
- significant physical or neurologic illness that can affect neuropsychological performance
- DSM-5 criteria of substance abuse or dependence
- inability to understand the purposes of the study
- absence of psychosocial interventions in the past 2 years (psychoeducation group, functional remediation, mindfulness)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Integrative treatment
|
The experimental group (62 patients) will take part on the integrative group program consisting of 12-sessions, 90 minutes each, once a week (4 focused on psychoeducation, 1 directed to the family relatives, 3 on mindfulness and 4 on functional remediation)
|
No Intervention: Control
The control group (62 patients) will not receive any type of add-on psychotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial functioning measured by functioning assessment short test
Time Frame: 15 days
|
The scale is interviewer-administered, designed for the assessment of psychosocial functioning.
The 24 items of the scale are divided among 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.
Each individual item is scored from 0 to 3. The global score (0-72) is obtained when the scores of each item are added up.
The higher the score, the more serious the difficulties.
|
15 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jose Sanchez-Moreno, Consorcio Centro de Investigación Biomédica en Red (CIBER)
Publications and helpful links
General Publications
- Valls E, Sanchez-Moreno J, Bonnin CM, Sole B, Prime-Tous M, Torres I, Brat M, Gavin P, Morilla I, Montejo L, Jimenez E, Varo C, Torrent C, Hidalgo-Mazzei D, Vieta E, Martinez-Aran A, Reinares M. Effects of an integrative approach to bipolar disorders combining psychoeducation, mindfulness-based cognitive therapy and functional remediation: Study protocol for a randomized controlled trial. Rev Psiquiatr Salud Ment (Engl Ed). 2020 Jul-Sep;13(3):165-173. doi: 10.1016/j.rpsm.2020.05.005. Epub 2020 Jul 7. English, Spanish.
- Valls E, Bonnin CM, Torres I, Brat M, Prime-Tous M, Morilla I, Segu X, Sole B, Torrent C, Vieta E, Martinez-Aran A, Reinares M, Sanchez-Moreno J. Efficacy of an integrative approach for bipolar disorder: preliminary results from a randomized controlled trial. Psychol Med. 2021 Apr 16;52(16):1-12. doi: 10.1017/S0033291721001057. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI17/00941
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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