EMDR vs Supportive Therapy in Relapse Prevention in Traumatized Bipolar Patients
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|ClinicalTrials.gov Identifier: NCT02634372|
Recruitment Status : Unknown
Verified August 2016 by Benedikt Amann, FIDMAG Germanes Hospitalàries.
Recruitment status was: Not yet recruiting
First Posted : December 18, 2015
Last Update Posted : August 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Behavioral: EMDR therapy Behavioral: Supportive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Single-blind, Randomized Controlled Comparison of EMDR Versus Supportive Therapy in Affective Relapse Prevention in Bipolar Patients With a History of Trauma|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2020|
Experimental: EMDR Therapy
EMDR: 20 individual sessions 60 minutes each for 6 months
Behavioral: EMDR therapy
EMDR: We designed a specific EMDR Bipolar Protocol which consists of a detailed interview with respect to traumatic events, the treatment of those with the EMDR standard protocol, and five new specific bipolar adapted EMDR protocols focusing on adherence, insight, de-idealisation of manic symptoms, prodromal symptoms and moodstabilization.
Active Comparator: Supportive therapy
Supportive therapy: 20 individual sessions 60 minutes each for 6 months.
Behavioral: Supportive Therapy
Supportive therapy: Therapists adopt a client-centred focus, meaning that whatever problems the patient presents will be dealt with by providing emotional support and general advise. If no specific topic is mentioned by the patient, information about bipolar disorder and medication will be delivered by the therapist without referring to written or any other material.
- Number of depressive, hypomanic, manic or mixed episodes [ Time Frame: Change of relapses from baseline to visits at 6, 12 and 24 months ]Affective relapses are defined as: Depressive relapse: score>18 in the BDRS, and a score>3 in the CGI-BP-M, depressive subscale. Hypomanic relapse: a YMRS score between 7 and 20, and a score of 3 or 4 in the CGI-BP-M, the manic subscale. Manic relapse: a YMRS score of >20, and the CGI-BP-M, the manic subscale, score>4. Mixed relapse: a BDRS score>10 in the mixed subscale (max. 15), and a score >4 in the CGI-BP-M, depressive and manic subscales.
- Depressive symptoms [ Time Frame: Change from baseline in depressive symptoms at 3, 6, 12 and 24 months ]To measure changes in depressive symptoms we will use the BDRS, and the CGI-BP-M, the depressive subscale.
- (Hypo)manic symptoms [ Time Frame: Change from baseline in (hypo)manic symptoms at 3, 6, 12 and 24 months ]To measure changes in (hypo)manic symptoms we will use the YMRS and the CGI-BP-M, the manic subscale.
- Mixed symptoms [ Time Frame: Change from baseline in mixed symptoms at 3, 6, 12 and 24 months ]To measure changes in mixed symptoms we will use the YMRS, the BDRS (mixed subscale) and the CGI-BP-M, the depressive and manic subscale.
- Trauma associated symptoms [ Time Frame: Change from baseline in trauma symptoms at 3, 6, 12 and 24 months ]To measure changes in trauma associated symptoms, the CAPS, IES, TLEQ and DEQ will be used.
- Functioning [ Time Frame: Change from baseline in functioning at 3, 6, 12 and 24 months ]To measure changes in functioning the FAST will be used.
- Cognitive impairment [ Time Frame: Change from baseline in cognition at 3, 6, 12 and 24 months ]To measure changes in cognition the SCIP will be used.
- Social cognition and emotional intelligence [ Time Frame: Change from baseline in cognition at 3, 6, 12 and 24 months ]To measure changes in social cognition and emotional intelligence the MSCEIT will be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634372
|Contact: Benedikt L Amann, MD||+34-936529999 ext firstname.lastname@example.org|
|Barcelona, Spain, 08035|
|Principal Investigator:||Benedikt L Amann, MD||FIDMAG Research Foundation|