Central Sensitization, Chronic Pain Syndrome, Posttraumatic Stress Symptom
Conditions
Keywords
Central Sensitivity Syndromes, Post-traumatic stress, Chronic pain, Treatment
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.
Interventions
BEHAVIORALCSS-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.
Sponsors
Ministerio de Ciencia, Innovación y Universidades, Spain
University of Malaga
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Study 2 will undertake an empirical investigation employing a manipulative strategy within an experimental design.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain interference | Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4). | 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. |
| 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). | 1. 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. 2. Quantitative sensory testing (QST). Tests that allow the nociceptive system to be comprehensively evaluated and obtain objective information on how pain is perceived. |
| 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). | 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. |
| Change in stress symptoms | Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4). | 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. |
| 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). | 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 |
| Change in sleep disturbance | Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4). | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (side effects) | Treatment (periprocedural) and 3-months follow-up, 6-months follow-up. | 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. |
| Change in medical data | Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4). | Medication intake (analgesics and psychotropic drugs), dose, and healthcare utilization. |
Countries
Spain
Outcome results
None listed