Effects of an Integrative Psychological Program in Bipolar Disorder (NCT04031560) | Clinical Trial Compass
UnknownNot Applicable
Effects of an Integrative Psychological Program in Bipolar Disorder
Spain124 participantsStarted 2018-03-25
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Psychosocial functioning measured by functioning assessment short test
Timeframe: 15 days
Trial details
NCT IDNCT04031560
SponsorConsorcio Centro de Investigación Biomédica en Red (CIBER)