Clinical trial NCT05619822: A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms
Official title: A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms; Design, Implementation and Effectiveness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Trauma, Psychological
Psychosis
Keywords: Psychosis
Trauma
Psychological Intervention
EMDR
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Existing data suggest that both trauma and Post-Traumatic Stress Disorder (PTSD) are very common among individuals with psychosis. The presence of PTSD symptoms in psychosis is associated with worse clinical outcomes and poorer social functioning. However, PTSD is a poorly attended and poorly studied condition among this population. Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when psychotic comorbidity is present. Recent systematic reviews of psychological interventions for trauma in psychosis found that are effective in reducing trauma symptoms, suggesting that they should be implemented in front-line services. Nonetheless, larger confirmative trials are required to form robust conclusions.The aim of this project is to examine the efficacy of comprehensive third-generation protocol for people with comorbid trauma and psychosis.

Detailed description: This study is a randomized clinical trial at psychiatric rehabilitation services of the Public Network of Care for people with serious mental disorders. We hypothesize that participants receiving the intervention, in comparison with controls, will show a reduction in general, PTSD and psychotic symptomatology, an improvement in levels of functioning and well-being, a greater ability to regulate emotions with more help-seeking behaviours.

Given the complexity of both psychosis and PTSD and the reluctance of professionals to treat it, we plan to develop a precise comprehensive protocol. In order to address all issues associated with both psychosis and comorbid PTSD, the protocol will be developed following the three stages of recovery from trauma: first, focusing on establishing the therapeutic alliance and safety; second, focusing on recounting and re-processing the traumatic event; and third, focusing on reconnecting with others and with life despite the trauma experienced. The therapy will be adapted to the characteristics of people with SMD and administered in 11 90-minute individual sessions per week, combining strategically ACT, Mindfulness, EMDR as well as Positive Psychology interventions.

Eligibility criteria: Inclusion Criteria:

Those showing a high risk of PTSD (TSQ ≥6) will be further evaluated to determine whether they meet the inclusion criteria. Participants must:

* Be between the ages of 18 and 65 fluent enough in Spanish language;
* Meet the criteria for a diagnosis of a psychotic spectrum disorder or a mood disorder with psychotic symptoms according to MINI (Sheeman et al., 1997);
* Meet PTSD diagnostic criteria according to the Clinician-Administered PTSD Scale (CAPS; Blake et al., 1995)

Exclusion Criteria:

* Those who have a diagnosis of substance or alcohol abuse or dependence in the 30 days prior to participation in the study
* To have a severe neurocognitive problems or brain damage that interfere with the basic processing of information in psychotherapy.

Primary outcomes:
measure: Change from posttraumatic symptoms at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
measure: Change from psychotic symptoms at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
measure: Change from psychopathological symptoms at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
measure: Change from dissociative symptoms at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
Secondary outcomes:
measure: Change from Personal and Social functioning at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
measure: Change from Wellbeing at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
measure: Change from satisfaction with life at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
measure: Change from Attachment at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
measure: Change from Emotion Regulation at 12 weeks and 6 months
timeFrame: Change baseline, 12 weeks, and 6 months
Other outcomes:
Locations:
city: Pozuelo de Alarcón
country: Spain
facility: Carmen Valiente
state: Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Carmen Valiente, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Camilo Jose Cela
name: Regina Espinosa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: