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
1 other identifier
interventional
124
1 country
1
Brief Summary
Bipolar disorder is related to a high level of personal, familial, social and economic burden. There is a need for feasible adjunctive psychological interventions to use in clinical practice as a complement of pharmacotherapy to enhance aspects that medication cannot reach. This project aims at develop and evaluate the impact of an adjunctive brief integrative program for bipolar patients (euthymic or with subthreshold symptoms). The patients (N=124) will be randomly assigned to two different groups. The experimental group (62 patients) will take part on a group integrative program consisting of 12-sessions of 90 minutes (based on psychoeducation, mindfulness and functional remediation) whilst the control group (62 patients) will not receive any sort of add-on psychotherapy. All patients will mantain standard psychiatric treatment. Together with the baseline assessment, the whole sample will be assessed after the intervention and at 12 months from the baseline evaluation, regarding sociodemographic, clinical and neuropsychological variables. If the intervention is effective it will improve psychosocial functioning (main variable), wellbeing and quality of life, as well as improve clinical outcomes and neurocognitive functioning of those affected by the illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2018
CompletedFirst Submitted
Initial submission to the registry
July 22, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedFebruary 2, 2024
August 1, 2023
6.5 years
July 22, 2019
February 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychosocial functioning measured by functioning assessment short test
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
Study Arms (2)
Experimental
EXPERIMENTALIntegrative treatment
Control
NO INTERVENTIONThe control group (62 patients) will not receive any type of add-on psychotherapy.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic of Barcelona
Barcelona, 08036, Spain
Related Publications (2)
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.
PMID: 32651030RESULTValls 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.
PMID: 33858527RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Sanchez-Moreno
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2019
First Posted
July 24, 2019
Study Start
March 25, 2018
Primary Completion
October 1, 2024
Study Completion
December 1, 2024
Last Updated
February 2, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share