EMDR vs Supportive Therapy in Relapse Prevention in Traumatized Bipolar Patients

NCT02634372 | Completed

• 1 other identifier: PI15/02242
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether EMDR (vs supportive therapy) is effective in relapse prevention over an observational period of 2 years in bipolar patients with a history of traumatic events.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Traumatic event; Eye Movement Desensitization Reprocessing; Supportive therapy; Relapse prevention

Outcome Measures

Primary Outcomes (1)

• Number of depressive, hypomanic, manic or mixed episodes

  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.

  Change of relapses from baseline to visits at 6, 12 and 24 months

Secondary Outcomes (7)

• Depressive symptoms

  Change from baseline in depressive symptoms at 3, 6, 12 and 24 months

• (Hypo)manic symptoms

  Change from baseline in (hypo)manic symptoms at 3, 6, 12 and 24 months

• Mixed symptoms

  Change from baseline in mixed symptoms at 3, 6, 12 and 24 months

• Trauma associated symptoms

  Change from baseline in trauma symptoms at 3, 6, 12 and 24 months

• Functioning

  Change from baseline in functioning at 3, 6, 12 and 24 months

Study Arms (2)

EMDR Therapy

EXPERIMENTAL

EMDR: 20 individual sessions 60 minutes each for 6 months

Behavioral: EMDR therapy

Supportive therapy

ACTIVE COMPARATOR

Supportive therapy: 20 individual sessions 60 minutes each for 6 months.

Behavioral: Supportive Therapy

Interventions

EMDR therapy BEHAVIORAL

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.

EMDR Therapy

Supportive Therapy BEHAVIORAL

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.

Supportive therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients fulfill diagnosis of bipolar I or II disorder, following DSM-IV-RT criteria
• Outpatients
• History of 2 to 6 affective episodes in previous year
• Patients are included in the study 1) in euthymia, defined as Bipolar Depression Rating Scale (BDRS) \<8 and Young Mania Rating Scale (YMRS) \<8 or 2) with subsyndromal symptoms, defined as BDRS ≥8 and \<14 and/or YMRS ≥8 and \<12
• Patients suffered at least from one traumatic event, evaluated by the Distressing Event Scale, Traumatic Life Events Questionnaire, Impact of Event Scale and Subjects Units of Distress.

You may not qualify if:

• Neurological disease
• Currently in a manic phase (YMRS\>18), mixed phase (BDRS≥10 in mixed subscale of BDRS, max.: 15) or depressive phase (BDRS \>18)
• Acute suicidal plans
• Substance Use Disorder within last 3 months (except of nicotine abuse/dependency)
• Trauma focused therapy within last 12 months.

Sponsors & Collaborators

• FIDMAG Germanes Hospitalàries: lead
• Hospital Clinic of Barcelona: collaborator
• Hospital del Mar: collaborator
• Hospital Universitari de Bellvitge: collaborator
• Instituto de Salud Carlos III: collaborator
• Centro de Investigación Biomédica en Red de Salud Mental: collaborator

Study Sites (1)

Institut Hospital del Mar d'Investigacions Mèdiques

Barcelona, 08035, Spain

Location

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MeSH Terms

Conditions

Bipolar Disorder

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Benedikt L Amann, MD

  Institut Hospital del Mar d'Investigacions Mèdiques

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research fellow

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 18, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Locations

ES (1)