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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02133170
Other study ID # HULP: 4094
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 30, 2014
Last updated May 6, 2014
Start date September 2014
Est. completion date June 2016

Study information

Verified date May 2014
Source Instituto de Investigación Hospital Universitario La Paz
Contact Consuelo De Dios Perrino, MD PhD
Email consuelo.dios@salud.madrid.org
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date June 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Psychoeducation
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 treatment
Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.

Locations

Country Name City State
Spain Hospital Universitario La Paz Madrid
Spain Hospital Santiago Apostol Vitoria Alava

Sponsors (2)

Lead Sponsor Collaborator
Instituto de Investigación Hospital Universitario La Paz Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other changes in the overall score of the Hamilton Depression Rating Scale (HDRS ) Changes in the overall score of the Hamilton Depression Rating Scale (HDRS ) from baseline (V0 ) to week 24 (V2) from baseline (V0 ) to week 24 (V2) No
Other Changes in the Young Mania Rating Scale (YMRS) Changes in the Young Mania Rating Scale (YMRS) from baseline (V0 ) to week 24 (V2) from baseline (V0 ) to week 24 (V2) No
Other Changes in the overall score of the Hamilton anxiety Scale HAM- A changes in the overall score of the Hamilton anxiety Scale HAM- A from baseline (V0 ) to week 24 (V2) from baseline (V0 ) to week 24 (V2) No
Other Cognitive changes 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
from baseline (V0 ) to week 24 (V2) No
Other Functioning: Functioning: changes in total scale score of the Functioning Assessment Short Test (FAST) from baseline (V0 ) to week 24 (V2) No
Other Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF) Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 2 from baseline (V0 ) to week 24 (V2) No
Other Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1 (end of intervention). from baseline (V0) to week 8 (V1) No
Primary 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. from baseline (V0) to week 8 (V1) No
Secondary 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) from baseline (V0) to week 8 (V1) No
Secondary 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 from baseline (V0) to week 8 (V1) No
Secondary 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 from baseline (V0) to week 8 (V1) No
Secondary 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
from baseline (V0) to week 8 (V1) No
Secondary Functioning Changes in total scale score of the Functioning Assessment Short Test (FAST) from baseline (V0) to week 8 (V1) No
Secondary Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF): changes from baseline to visit 1 from baseline (V0) to week 8 (V1) No
Secondary 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. from baseline (V0) to week 8 (V1) No
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