BipolarBI-MINDNCT02133170
"Mindfulness vs Psychoeducation in Bipolar Disorder"
A study testing Mindfulness Based Cognitive Therapy (MBCT), Psychoeducation and Standard treatment in people with Bipolar and Depressive Symptoms, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.
Trial summary
This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar, Depressive Symptoms
- What is being tested?
- Mindfulness Based Cognitive Therapy (MBCT), Psychoeducation and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2014to Jun 2016
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-60 years
- BD type I or II, in clinical remission of acute mood episode at least in the three months prior to study
- Having presented an acute affective episode in the past 3 years
- Having presented at least two depressive episodes throughout his life.
- Monotherapy or combination with a mood stabilizer (lithium, valproate, carbamazepine or lamotrigine) at optimal doses (ie, in serum levels within the therapeutic range: 0.6-1.2 mEq / L for lithium, 50-100 ug / ml for valproate, and 5-12 mcg / mL for carbamazepine), or quetiapine monotherapy or in combination with the aforementioned stabilizers, or any oral atypical antipsychotic in combination with an antidepressant
- Hamilton Depression Rating Scale [HDRS]-17 score ≥ 8 and ≤ 19 and Young Mania Rating Scale [YMRS] score <8
- Being able to understand and comply with the requirements of the trial
- Written consent to participate in the study.
Who cannot join
- Any acute mood episode in the 12 weeks before the start of the trial.
- Any current DSM -5 diagnosis different from bipolar disorder (including substance or alcohol use disorder at the time of study entry, except if it is under complete remission. Not applicable to nicotine or caffeine)
- Risk of suicide or self/hetero aggressiveness
- Pregnancy
- Severe and unstable medical pathology.
- Patients who are currently receiving structured psychotherapy or structured group psychoeducation about bipolar disorder, or who have received structured psychoeducation in the past 5 years
Show all 10Show fewer
- Patients who are treated with a different mood stabilizer to lithium , valproate , carbamazepine , lamotrigine, a classic antipsychotic or antidepressant monotherapy at the time of the randomization
- Treatment with a depot antipsychotic
- Participation in another clinical trial within 4 weeks prior to randomization
- Mental Retardation
Trial locations and contacts
2 sites in 1 country.
Consuelo De Dios Perrino, MD PhD contact
Spain2 sites
Hospital Universitario La Paz
Madrid, Madrid, 28046
Consuelo De Dios Perrino, consuelo.dios@salud.madrid.org
Consuelo De Dios Perrino, MD PhD
Hospital Santiago Apostol
Vitoria-Gasteiz, Alava, 01004
Margarita Sanz Herrero, MD
About this study
Official title: Comparative Efficacy of Two Adjunctive Psychosocial Interventions (Mindfulness or Psychoeducation) Versus Treatment as Usual in Bipolar Patients With Subsyndromal Deppresive Symptoms: A Pilot Randomized Trial
This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric care with standard pharmacologic treatment.
Read the detailed description
This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric care with standard pharmacologic treatment. After written informed consent is signed, patients meeting the inclusion criteria are randomized (2:2:1 ratio) through a Random Allocation Software. All three groups are assessed at baseline (t0), immediately after completing the program (t1; 8 weeks) and at follow-up six months after randomization. The assessments include the following variables: depression, anxiety, general and social cognition, global functioning, BDNF, and other clinical variables. The evaluator who collected the biomarkers and the clinical and psychometric data will be blind to treatment. The interrater variability between all researchers will be checked.
- Conditions
- Bipolar, Depressive Symptoms
- Being tested
- Mindfulness Based Cognitive Therapy (MBCT), Psychoeducation, Standard treatment
- Keywords
- BIPOLAR DISORDER, DEPRESSIVE SYMPTOMS, MINDFULNESS, PSYCHOEDUCATION, BIPOLAR PATIENTS WITH DEPRESSIVE SYMPTOMS
- Medical subject headings
- Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive Therapy (MBCT)Behavioural
The MBCT program is conducted in HULP (BRV and CBP), which also train therapists from Vitoria, in order to homogenize the intervention. Random sessions are video or audio recorded to be discussed and analyzed by the treatment team. The manualized MBCT therapy consists of 8 weekly sessions of 90 minutes and is applied in groups of approximately 10-15 patients. At least two programs in H. La Paz and two in the hospital de Santiago (Vitoria) will be provided.
PsychoeducationBehavioural
Psychoeducation program will be held in groups of 10 to 15 patients in 90-minute weekly sessions led by two therapists also outside the research team. The specific program of 8 sessions is focused addressing disease awareness, adherence to treatment and early detection of prodromal symptoms. Homework will also be included. The program is based on the Psychoeducation Manual for Bipolar Disorder . F.Colom , E.Vieta . Ars Medica, 2004. Attendance at least 80 % of the sessions of both interventions will be required to be considered complete.
Standard treatmentBehavioural
Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.
| Study group | Role | What they receive |
|---|---|---|
| Psychopharmacological + MBCT | Active comparator | psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT) Receives: Behavioral: Mindfulness Based Cognitive Therapy (MBCT) |
| psychopharmacological + psychoeducation | Active comparator | psychopharmacological treatment plus structured group psychoeducation; Receives: Behavioral: Psychoeducation |
| Psychopharmacological treatment. | Other | Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment. Receives: Behavioral: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS), from baseline (V0) to week 8 (v1) for each of the treatment groups.
Measured: from baseline (V0) to week 8 (V1)
Secondary outcomes (7)
Changes in the global score of Young Mania Rating Scale (YMRS)
Changes in the global score of Young Mania Rating Scale (YMRS) from baseline (V0) to visit 1 (at the end of surgery 8 weeks (v1)
Measured: from baseline (V0) to week 8 (V1)
Changes in scale score of Clinical Global Impression CGI-BP
Changes in scale score of Clinical Global Impression CGI-BP from baseline (V0) to visit 1
Measured: from baseline (V0) to week 8 (V1)
Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A
Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A from baseline (V0) to visit 1
Measured: from baseline (V0) to week 8 (V1)
Cognitive changes
Changes at the end of the intervention will be assessed with the following measures:
- sustained and selective attention
- working memory and executive functions
- perception of the attitude of mindfulness ( FFMQ ) in patients in the experimental group
- scales of social cognition
Measured: from baseline (V0) to week 8 (V1)
Functioning
Changes in total scale score of the Functioning Assessment Short Test (FAST)
Measured: from baseline (V0) to week 8 (V1)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1
Measured: from baseline (V0) to week 8 (V1)
Recurrence
Recurrence, defined as the emergence of a new acute episode whether depressive, mixed, hypo or manic at any time throughout the study, according to DSM-5 clinical criteria or when the score on the HDRS scale is ≥ 20 ( depressive episode ) or the Young scale ( YMRS ≥ 8) (hypo/manic episode), or a change drug or hospitalization is needed.
Measured: from baseline (V0) to week 8 (V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BipolarStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Consuelo De Dios Perrino, MD PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133170
- Sponsor's protocol ID
- HULP: 4094
- Acronym
- BI-MIND
- Status last verified
- May 2014
- First submitted
- 30 Apr 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Carracedo-Sanchidrian D, de Dios-Perrino C, Bayon-Perez C, Rodriguez-Vega B, Bravo-Ortiz MF, Ortega MA, Gonzalez-Pinto AM, Lahera G. Effect of mindfulness-based cognitive therapy vs. psychoeducational intervention on plasma brain-derived neurotrophic factor and cognitive function in bipolar patients: a randomized controlled trial. Front Psychiatry. 2024 Jan 5;14:1279342. doi: 10.3389/fpsyt.2023.1279342. eCollection 2023.
PubMed 38250270Lahera G, Bayon C, Fe Bravo-Ortiz M, Rodriguez-Vega B, Barbeito S, Saenz M, Avedillo C, Villanueva R, Ugarte A, Gonzalez-Pinto A, de Dios C. Mindfulness-based cognitive therapy versus psychoeducational intervention in bipolar outpatients with sub-threshold depressive symptoms: a randomized controlled trial. BMC Psychiatry. 2014 Aug 15;14:215. doi: 10.1186/s12888-014-0215-x.
PubMed 25124510
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Two Adjunctive Psychosocial Interventions (Mindfulness or Psychoeducation) Versus Treatment as Usual in Bipolar Patients With Subsyndromal Deppresive Symptoms: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT02133170
- Acronym / sponsor ID
- BI-MIND / HULP: 4094
- Conditions
- Bipolar, Depressive Symptoms
- Keywords
- BIPOLAR DISORDER, DEPRESSIVE SYMPTOMS, MINDFULNESS, PSYCHOEDUCATION, BIPOLAR PATIENTS WITH DEPRESSIVE SYMPTOMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 7 May 2014 (estimated)
- 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.
This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric care with standard pharmacologic treatment.
Detailed description
This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric care with standard pharmacologic treatment. After written informed consent is signed, patients meeting the inclusion criteria are randomized (2:2:1 ratio) through a Random Allocation Software. All three groups are assessed at baseline (t0), immediately after completing the program (t1; 8 weeks) and at follow-up six months after randomization. The assessments include the following variables: depression, anxiety, general and social cognition, global functioning, BDNF, and other clinical variables. The evaluator who collected the biomarkers and the clinical and psychometric data will be blind to treatment. The interrater variability between all researchers will be checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychopharmacological + MBCT | Active comparator | Behavioral: Mindfulness Based Cognitive Therapy (MBCT)psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT) |
| psychopharmacological + psychoeducation | Active comparator | Behavioral: Psychoeducationpsychopharmacological treatment plus structured group psychoeducation; |
| Psychopharmacological treatment. | Other | Behavioral: Standard treatmentTreatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 18-60 years
- BD type I or II, in clinical remission of acute mood episode at least in the three months prior to study
- Having presented an acute affective episode in the past 3 years
- Having presented at least two depressive episodes throughout his life.
- Monotherapy or combination with a mood stabilizer (lithium, valproate, carbamazepine or lamotrigine) at optimal doses (ie, in serum levels within the therapeutic range: 0.6-1.2 mEq / L for lithium, 50-100 ug / ml for valproate, and 5-12 mcg / mL for carbamazepine), or quetiapine monotherapy or in combination with the aforementioned stabilizers, or any oral atypical antipsychotic in combination with an antidepressant
Key exclusion criteria (10 listed)
- Any acute mood episode in the 12 weeks before the start of the trial.
- Any current DSM -5 diagnosis different from bipolar disorder (including substance or alcohol use disorder at the time of study entry, except if it is under complete remission. Not applicable to nicotine or caffeine)
- Risk of suicide or self/hetero aggressiveness
- Pregnancy
- Severe and unstable medical pathology.
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 |
|---|---|---|
| Mindfulness Based Cognitive Therapy (MBCT)The MBCT program is conducted in HULP (BRV and CBP), which also train therapists from Vitoria, in order to homogenize the intervention. Random sessions are video or audio recorded to be discussed and analyzed by the treatment team. The manualized MBCT therapy consists of 8 weekly sessions of 90 minutes and is applied in groups of approximately 10-15 patients. At least two programs in H. La Paz and two in the hospital de Santiago (Vitoria) will be provided. | Behavioural | Psychopharmacological + MBCT |
| PsychoeducationPsychoeducation program will be held in groups of 10 to 15 patients in 90-minute weekly sessions led by two therapists also outside the research team. The specific program of 8 sessions is focused addressing disease awareness, adherence to treatment and early detection of prodromal symptoms. Homework will also be included. The program is based on the Psychoeducation Manual for Bipolar Disorder . F.Colom , E.Vieta . Ars Medica, 2004. Attendance at least 80 % of the sessions of both interventions will be required to be considered complete. | Behavioural | psychopharmacological + psychoeducation |
| Standard treatmentTreatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment. | Behavioural | Psychopharmacological treatment. |
Primary outcome
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)
Time frame: from baseline (V0) to week 8 (V1)
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS), from baseline (V0) to week 8 (v1) for each of the treatment groups.
7 secondary outcomes
Changes in the global score of Young Mania Rating Scale (YMRS)
Time frame: from baseline (V0) to week 8 (V1)
Changes in scale score of Clinical Global Impression CGI-BP
Time frame: from baseline (V0) to week 8 (V1)
Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A
Time frame: from baseline (V0) to week 8 (V1)
Cognitive changes
Time frame: from baseline (V0) to week 8 (V1)
Functioning
Time frame: from baseline (V0) to week 8 (V1)
Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):
Time frame: from baseline (V0) to week 8 (V1)
Recurrence
Time frame: from baseline (V0) to week 8 (V1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Derived from this study: PubMed 38250270Carracedo-Sanchidrian D, de Dios-Perrino C, Bayon-Perez C, Rodriguez-Vega B, Bravo-Ortiz MF, Ortega MA, Gonzalez-Pinto AM, Lahera G. Effect of mindfulness-based cognitive therapy vs. psychoeducational intervention on plasma brain-derived neurotrophic factor and cognitive function in bipolar patients: a randomized controlled trial. Front Psychiatry. 2024 Jan 5;14:1279342. doi: 10.3389/fpsyt.2023.1279342. eCollection 2023.
- Derived from this study: PubMed 25124510Lahera G, Bayon C, Fe Bravo-Ortiz M, Rodriguez-Vega B, Barbeito S, Saenz M, Avedillo C, Villanueva R, Ugarte A, Gonzalez-Pinto A, de Dios C. Mindfulness-based cognitive therapy versus psychoeducational intervention in bipolar outpatients with sub-threshold depressive symptoms: a randomized controlled trial. BMC Psychiatry. 2014 Aug 15;14:215. doi: 10.1186/s12888-014-0215-x.
- Related InfoLink provided by the sponsor.
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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.
Consuelo De Dios Perrino, MD PhD contact
Consuelo De Dios Perrino, MD PhD principal investigator
Hospital Universitario La Paz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy (MBCT), Psychoeducation and Standard treatment in people with Bipolar and Depressive Symptoms, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Consuelo De Dios Perrino, MD PhD (consuelo.dios@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS) (time frame: from baseline (V0) to week 8 (V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02133170, which also lists 2 linked publications.
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 7 May 2014; AzTrials last refreshed its copy on 2 Nov 2026.