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

NCT07313280 | Enrolling By Invitation DMC

• 1 other identifier: PID2023-152784OA-I00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Central Sensitization; Chronic Pain Syndrome; Posttraumatic Stress Symptom

Keywords

Central Sensitivity Syndromes; Post-traumatic stress; Chronic pain; Treatment

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Change in Central Sensitization Indexes

  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

  Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).

• Change in 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

  Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).

• Change in sleep disturbance

  Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).

Other Outcomes (2)

• Adverse Events (side effects)

  Treatment (periprocedural) and 3-months follow-up, 6-months follow-up.

• Change in medical data

  Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).

Study Arms (4)

Profile 1_Reactive

EXPERIMENTAL

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

Profile 2_Dysphoric

EXPERIMENTAL

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

Profile 3_Dissociative

EXPERIMENTAL

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

Profile 4_Mixed

EXPERIMENTAL

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

Interventions

CSS-PTSD psychological interventions BEHAVIORAL

The interventions will be developed based on the techniques previously developed within cognitive behavioural approaches, which have demonstrated efficacy in treating both conditions.

Profile 1_Reactive; Profile 2_Dysphoric; Profile 3_Dissociative; Profile 4_Mixed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministerio de Ciencia, Innovación y Universidades, Spain: collaborator
• University of Malaga: lead

Study Sites (3)

Hospital Universitario Regional de Málaga_Hospital Civil

Málaga, Málaga, 29009, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

Location

Área de Gestión Sanitaria Este de Málaga-Axarquía

Málaga, Torre Del Mar, 29740, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study 2 will undertake an empirical investigation employing a manipulative strategy within an experimental design.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 31, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)