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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in anxiety sensitivity — Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
  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.
• Change in emotion dysregulation — Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
  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.
• Change in experiential avoidance — Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
  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.
• Change in distress intolerance — Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
  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.
• Change in dissociative symptoms — Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
  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.
• Change in daily symptom monitoring — Treatment (periprocedural), 1-months follow-up.
  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.

Trial sites (3)

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