Central Sensitization Syndromes and Post-Traumatic Stress in Women: Psychological Profile and Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CSS-PTSD psychological interventions.
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Symptom, Central Sensitization, Chronic Pain Syndrome. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Psychological Profile Associated With the Complexity of Central Sensitization Syndromes, Comorbid With Trauma and Post-Traumatic Stress Disorder in Women: Testing the Effectiveness of a Person-Centered Psychological Intervention
Overview
Central Sensitivity Syndromes (CSSs) are a group of conditions that are highly prevalent, particularly among women, and often occur alongside post-traumatic stress disorder (PTSD). This research project has two aims: Study 1) to investigate the psychological profiles of women with CSS-PTSD comorbidity; and Study 2) to design and evaluate the effectiveness of distinct interventions for each profile identified in Study 1.
Detailed description
Central Sensitivity Syndromes (CSSs) are a group of conditions, including fibromyalgia and chronic pelvic pain, associated with symptoms such as perceived pain intensity, depression, anxiety, stress, sleep disturbances, and disability. These syndromes are highly prevalent, particularly among women, and often occur alongside post-traumatic stress disorder (PTSD). This condition stems from a variety of traumatic experiences and manifests as a range of symptoms in individuals with different psychological profiles. However, not all individuals who experience trauma develop PTSD or CSSs, nor do all individuals with CSSs have PTSD or exhibit the same symptom patterns. Transdiagnostic psychological variables may contribute to the development and maintenance of both conditions. Commonly observed factors in both CSSs and PTSD include emotional dysregulation, anxiety sensitivity, experiential avoidance, distress intolerance, and dissociation. These transdiagnostic vulnerability variables could be associated with each profile. Identifying these profiles may enable targeted interventions that address the underlying vulnerabilities driving CSS-PTSD comorbidity. By aligning treatment to individual vulnerability patterns, this approach aims to improve outcomes for women affected by CSS-PTSD.
Four PTSD profiles will be identified:
* Reactive (with prominent intrusions, avoidance, and hyperarousal). * Dysphoric (with anhedonia and negative affect). * Dissociative (with high negative and positive dissociative symptoms). * Mixed (with high levels of all PTSD symptoms). However, no studies have analysed how these transdiagnostic vulnerability variables (emotion dysregulation, anxiety sensitivity, experiential avoidance, distress intolerance, and dissociation) are grouped and shape the different PTSD symptom profiles in populations with either PTSD or comorbid CSS. Therefore, the analysis of the association between PTSD profiles and transdiagnostic variables is exploratory.
The treatments will be developed based on the variables associated with each profile identified in Study 1.
Interventions
- Behavioral CSS-PTSD psychological interventions
The interventions will be developed based on the techniques previously developed within cognitive behavioural approaches, which have demonstrated efficacy in treating both conditions.
Primary outcome measures
- Change in anxiety sensitivity [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in emotion dysregulation [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in experiential avoidance [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in distress intolerance [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in dissociative symptoms [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in daily symptom monitoring [Time frame: Treatment (periprocedural), 1-months follow-up.]
Secondary outcome measures (6)
- Change in Central Sensitization Indexes [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in posttraumatic stress symptoms [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in stress symptoms [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in anxiety and depressive symptoms [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in sleep disturbance [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
- Change in pain interference [Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).]
Eligibility criteria
Inclusion criteria
- being a biological woman.
- having a medical diagnosis of CSS.
- scoring >36 on the Posttraumatic Stress Disorder Checklist for DSM-5, which indicates PTSD in people with chronic pain.
- having the ability to understand and sign the informed consent form.
Exclusion criteria
- having a diagnosis of serious mental illness or neurodegenerative disease.
- not being fluent in spoken and written Spanish.
- undergoing treatment for an oncological, degenerative, or terminal disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 3 centers
- Hospital Universitario Regional de Málaga_Hospital Civil — Málaga
- Hospital Universitario Virgen de la Victoria — Málaga
- Área de Gestión Sanitaria Este de Málaga-Axarquía — Málaga
Identifiers
NCT: NCT07313280 · PID2023-152784OA-I00