Central Sensitization Syndromes and Post-Traumatic Stress in Women: Psychological Profile and Intervention (SINSENTRA)

University of Malaga

Status: Invitation-only

Conditions: Chronic Pain Syndrome; Central Sensitization; Posttraumatic Stress Symptom

Treatments: Behavioral: CSS-PTSD psychological interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT07313280

PID2023-152784OA-I00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. being a biological woman.
2. having a medical diagnosis of CSS.
3. scoring >36 on the Posttraumatic Stress Disorder Checklist for DSM-5, which indicates PTSD in people with chronic pain.
4. having the ability to understand and sign the informed consent form.

Exclusion criteria

1. having a diagnosis of serious mental illness or neurodegenerative disease.
2. not being fluent in spoken and written Spanish.
3. undergoing treatment for an oncological, degenerative, or terminal disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 4 patient groups

Profile 1_Reactive

Experimental group

Description:

The arms will be developed based on the psychological profile identified in Study 1, given that a better understanding of CSS-PTSD comorbidity is necessary to design an effective intervention targeting the specific variables maintaining this condition.

Treatment:

Behavioral: CSS-PTSD psychological interventions

Profile 2_Dysphoric

Experimental group

Description:

The arms will be developed based on the psychological profile identified in Study 1, as a better understanding of CSS-PTSD comorbidity is necessary to design an effective intervention targeting the specific variables that maintain this condition.

Treatment:

Behavioral: CSS-PTSD psychological interventions

Profile 3_Dissociative

Experimental group

Description:

The arms will be developed based on the psychological profile identified in Study 1, given that a better understanding of CSS-PTSD comorbidity is necessary to design an effective intervention targeting the specific variables maintaining this condition.

Treatment:

Behavioral: CSS-PTSD psychological interventions

Profile 4_Mixed

Experimental group

Description:

The arms will be developed based on the psychological profile identified in Study 1, as a better understanding of CSS-PTSD comorbidity is necessary to design an effective intervention targeting the specific variables that maintain this condition.

Treatment:

Behavioral: CSS-PTSD psychological interventions