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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Malaga
- Enrollment
- 12
- Locations
- 6
- Primary Endpoint
- Change in anxiety sensitivity
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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).
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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).)
- Change in pain interference(Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).)
Investigators
Elena R. Serrano-Ibáñez
Principal Investigator
University of Malaga