CSS-PTSD psychological interventions
BehavioralThe interventions will be developed based on the techniques previously developed within cognitive behavioural approaches, which have demonstrated efficacy in treating both conditions.
NCT Number: NCT07313280
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.
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Hospital Universitario Regional de Málaga_Hospital Civil, Málaga, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The interventions will be developed based on the techniques previously developed within cognitive behavioural approaches, which have demonstrated efficacy in treating both conditions.
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.
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.
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.
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.
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.
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.
Time frame: Pre-treatment (T1), Post-treatment (T2; 24 weeks after T1), 3-months follow-up (T3), 6-months follow-up (T4).
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 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.
Time frame: 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.
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 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
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Malaga
Other
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
Acronym: SINSENTRA
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