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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Central Sensitization; Chronic Pain Syndrome; Posttraumatic Stress Symptom
• Intervention / Treatment: Behavioral: CSS-PTSD psychological interventions

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga
    • Málaga, Málaga, Spain, 29010
      • Hospital Universitario Virgen de la Victoria
    • Málaga, Málaga, Spain, 29009
      • Hospital Universitario Regional de Málaga_Hospital Civil
  • Torre Del Mar
    • Málaga, Torre Del Mar, Spain, 29740
      • Área de Gestión Sanitaria Este de Málaga-Axarquía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Profile 1_Reactive; 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.	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.
Experimental: Profile 2_Dysphoric; 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.	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.
Experimental: Profile 3_Dissociative; 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.	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.
Experimental: Profile 4_Mixed; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety sensitivity	The Spanish version of the Anxiety Sensitivity Index (ASI-3). It is a 16-item questionnaire; items are rated from 0 ("Not at all or almost nothing) to 4 ("Very much"), with higher total scores indicating greater anxiety sensitivity.	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
Change in emotion dysregulation	The Spanish brief version of the Difficulties in Emotion Regulation Scale (DERS-S SF). It comprises 18 items with a 5-point Likert scale, from 1("Almost never) to 5 "Almost always") divide into 5 subscales: nonacceptance of emotional responses, difficulty engaging in goal-directed behaviour, impulse control difficulties, limited access to emotion regulation strategies, and lack of emotional clarity. Higher total scores indicate greater difficulties in emotion regulation.	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
Change in experiential avoidance	The Spanish version of the Acceptance and Action Questionnaire II (AAQ II). It is a brief 7-item instrument; items are a 7-point Likert-type scale, ranging from 1 ("Never") to 7 ("Always"). Higher total scores indicate greater experiential avoidance.	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
Change in distress intolerance	The Spanish version of the Distress Tolerance Scale (DTS). It is a 15-item questionnaire; items are rated from 1 ("Strongly agree") to 5 ("Strongly disagree"), with higher total scores indicating greater distress tolerance.	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
Change in dissociative symptoms	The Spanish version of the abbreviated scale of the Dissociative Experiences Scale-Modified (DES-M). It consists of 18 questions, rated on a 5-point Likert-type scale (ranging from 1 = "Never" to 5 = "Always"), with higher total scores indicating greater dissociative symptoms.	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	Participants will complete an electronic diary from the time of the initial assessment until 30 days post-intervention. Electronic diary developed and validated by Åkerblom et al., 2022.	Treatment (periprocedural), 1-months follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Central Sensitization Indexes	Spanish Central Sensitization Inventory (CSI). It is a 25-item questionnaire that comprises a 5-point Likert scale, ranging from 0 ('Never') to 4 ('Always'). Higher total scores indicate greater central sensitization symptoms.; Quantitative sensory testing (QST). Tests that allow the nociceptive system to be comprehensively evaluated and obtain objective information on how pain is perceived.	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	The Spanish version of the Posttraumatic Stress Disorder Checklist-5 (PCLC-5). A 20-item self-report, with a Likert-type scale ranging from 1 ("Not at all") to 5 ("Very much"). Higher total scores indicate greater posttraumatic stress symptoms.	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
Change in stress symptoms	Stress subscale of the Depression Anxiety Stress Scale (DASS-21). It is a 7-item subscale; items are rated from 0 ("Never") to 3 ("Almost always"), with higher total scores indicating greater stress symptoms.	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	The Spanish version of the Hospital Anxiety and Depression Scale (HADS). It has two subscales (Anxiety and Depression) with 7 questions each, scored 0-3, totaling 0-21 per subscale, where higher scores indicate greater severity	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
Change in sleep disturbance	The Spanish version of PROMIS 8b-item Sleep Disturbance Scale. It uses 8 questions to assess difficulty falling/staying asleep, restlessness, and satisfaction, scored on a 5-point Likert scale (from 1 = "Never" to 5 = "Always"), with higher scores indicating worse sleep quality.	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
Change in pain interference	The Short Form of the Brief Pain Inventory (BPI-SF). A 9-item self-report questionnaire assessing pain severity (worst, least, average, current) and its interference with daily life (activity, mood, sleep, work, etc.); items are rated from 0 ("no pain"/"not interferes") to 4 ("worst pain imaginable" /"completely interferes"), with higher total scores indicating greater pain interference.	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (side effects)	Adverse Events are not expected given the content of the treatment and its non-invasive nature, however, they will be assessed, recorded and controlled for in the analyses.	Treatment (periprocedural) and 3-months follow-up, 6-months follow-up.
Change in medical data	Medication intake (analgesics and psychotropic drugs), dose, and healthcare utilization.	Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: Ministerio de Ciencia, Innovación y Universidades, Spain

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Treatment; Chronic pain; Post-traumatic stress; Central Sensitivity Syndromes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: PID2023-152784OA-I00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No