Psychological Trauma Clinical Trial
Official title:
A Multicenter Phase II Rater-blinded Randomized Controlled Trial (RCT) to Compare Effectiveness of Eye Movement Desensitization Reprocessing Therapy (EMDR) vs Treatment as Usual (TAU) in First Episode Psychosis and History of Trauma.
Verified date | February 2024 |
Source | Parc de Salut Mar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this project is to analyze whether EMDR therapy, as an adjuvant to usual treatment, is effective in reducing post-traumatic stress and psychotic/affective symptoms in patients with a FEP and comorbid psychological trauma associated with first hospital admission and / or previous stressful life event.
Status | Active, not recruiting |
Enrollment | 71 |
Est. completion date | December 31, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - age =16 years old - presence of one or more traumatic events, causing symptoms associated with the trauma (Impact of Event Scale-Revised >0 and Subjective Units of Distress >5), but it is not necessary that traumatic events meet DSM-5 criteria for PTSD - psychotic symptoms/psychiatric hospitalization will be considered a traumatic event when the criteria for a trauma-related disorder or stress factors according to DSM-V (Post-Traumatic Stress Disorder, Acute Stress Disorder, and Other Trauma-related Disorder and unspecified stress factors) are also met - ability to read and write in Spanish. Exclusion Criteria: - current suicidal risk - presence of organic brain diseases - have received trauma-focused therapy in the past 2 years. |
Country | Name | City | State |
---|---|---|---|
Spain | Parc de Salut Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar | Althaia Xarxa Assistencial Universitària de Manresa, Consorci Hospitalari de Vic, Hospital Mutua de Terrassa |
Spain,
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* Note: There are 60 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of the severity of trauma-related symptoms | To measure severity and changes in trauma-related symptoms with the Impact of Event Scale - Revised. Items are rated on a 5-point Likert scale ranging from 0 and 4, yielding a total score ranging from 0 to 88. | Change from baseline to visits at 6 and 12 months | |
Secondary | Making a PTSD diagnosis | To diagnose PTSD with the Global Assessment of Posttraumatic Stress Questionnaire. Higher scores indicate more severity in trauma-related symptoms. | Change from baseline to visits at 6 and 12 months | |
Secondary | Detection of dissociative symptoms | To assess dissociative symptoms with the Dissociative Experiences Scale. An overall mean score ranging from 0 to 100. The higher score, the higher the severity of the dissociative symptoms. | Change from baseline to visits at 6 and 12 months | |
Secondary | Detection of Childhood life traumatic events | To assess life events with the Childhood Trauma Questionnaire. A 5-point Likert scale is used, ranging from "Never True" to "Very Often True". | Childhood period. It is administered only during the baseline visit. | |
Secondary | Detection of traumatic events in the last year | To assess events with The Holmes-Rahe Life Stress Inventory. Scores below 150 reflect low levels of stress, scores between 150 and 299 represent a 50% risk of a stress-related illness in the near future and scores above 300 represent an 80% risk. | The last year. It is administered only during the baseline visit. | |
Secondary | Reduction of positive psychotic symptoms | To measure changes in the Positive and Negative Syndrome Scale (PANSS) . It ranges from 7 to 49: the higher the score, the worse the positive psychotic symptoms. | Change from baseline to visits at 6 and 12 months | |
Secondary | Reduction in depressive symptoms | To measure changes in the Beck Depression II Questionnaire. Total scores range from 0 to 52: the higher the score, the worse the depressive symptoms. | Change from baseline to visits at 6 and 12 months | |
Secondary | Reduction of (hypo) manic symptoms | To measure changes in the Young Mania Rating Scale. It ranges from 0 to 130: the higher the score, the worse the manic symptoms. | Change from baseline to visits at 6 and 12 months | |
Secondary | Improvement of global functioning | To measure changes with the Global Assessment of Functioning Scale. The global score ranges from 0 to 100. The higher the score, the higher the functional status. | Change from baseline to visits at 6 and 12 months | |
Secondary | Improving of the quality of life associated with health | To measure changes with the Standardized Instrument for Evaluating Quality of Life Associated with Health.The global score ranging from 0 to 100. The lower scores indicate poorer awareness of the quality of life associated with health. | Change from baseline to visits at 6 and 12 months | |
Secondary | Improving awareness of having a mental disorder and of their need for treatment | To measure changes in the with the Beck Cognitive Insight Scale. The total score ranging from 0 to 45. The higher score on the scale, the lower severity of negative symptomatology. | Change from baseline to visits at 6 and 12 months | |
Secondary | Improving adherence to pharmacological treatment | To measure changes in the attitude towards medication with the Drug Attitude Inventory. The total score can oscillate between 10 and 20. The higher the score, the more positive the perceived effect of the medication. | Change from baseline to visits at 6 and 12 months | |
Secondary | Reducing in the number of relapses | To measure relapses with the register of the number hospital admissions and/or emergency visits | Change from baseline to visits at 6 and 12 months |
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