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| Name | Class |
|---|---|
| Ministerio de Ciencia e Innovación, Spain | OTHER_GOV |
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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.
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:
The treatments will be developed based on the variables associated with each profile identified in Study 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Central Sensitization Indexes |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Regional de Málaga_Hospital Civil | Málaga | Málaga | 29009 | Spain | ||
| Hospital Universitario Virgen de la Victoria |
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Study 2 will undertake an empirical investigation employing a manipulative strategy within an experimental design.
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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. |
| 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). |
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). |
| Málaga |
| Málaga |
| 29010 |
| Spain |
| Área de Gestión Sanitaria Este de Málaga-Axarquía | Málaga | Torre Del Mar | 29740 | Spain |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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