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L'essai clinique NCT06301360 pour Trouble somatique fonctionnel, Trouble à symptomatologie somatique, Functional Somatic Syndromes est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06301360 est un essai interventionnel pour Trouble somatique fonctionnel, Trouble à symptomatologie somatique, Functional Somatic Syndromes. Son statut actuel est : en recrutement. L'étude a débuté le 1 décembre 2023 et vise à recruter 150 participants. Dirigé par Daniel Maroti, l'essai devrait être terminé d'ici le 31 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 mars 2024.
Résumé succinct
Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned.

Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT).

The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created.

The research question for this specific study is:

Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD?

Titre officiel

How Much Does the Therapist Matter in Internet Based Emotional Awareness and Expression Therapy (I-EAET) for Functional Somatic Disorder? A Randomised Controlled Trial of I-EAET With and Without Therapist Support

Conditions
Trouble somatique fonctionnelTrouble à symptomatologie somatiqueFunctional Somatic Syndromes
Autres identifiants de l'essai
  • KOSMOS2 2023-04956-01
Numéro NCT
Date de début (réel)
2023-12-01
Dernière mise à jour publiée
2024-03-12
Date de fin (estimée)
2025-12-31
Inscription (estimée)
150
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Internet based interventions
EAET
Psychodynamic therapy
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalI-EAET with therapist support
I-EAET is a 10 week treatment intervention combining principles from emotion focused therapies and neuroscience. Main components include psychoeducation on the body-mind connection, anxiety regulation with self-compassion exercises and different techniques for emotional exposure and processing. Participants have help from a therapist giving feedback.
Internet Based Emotional Awareness and Expression Therapy (I-eaet)
In I-EAET with therapist support, the therapist and participants communicate asynchronous using written messages. The therapist gives feedback each week on home-work assignments and is available on demand for support. In I-EAET without therapist support, the participants works with home-work assignments on their own and only have technical support.
Comparateur actifI-EAET without therapist support
I-EAET is a 10 week treatment intervention combining principles from emotion focused therapies and neuroscience. Main components include psychoeducation on the body-mind connection, anxiety regulation with self-compassion exercises and different techniques for emotional exposure and processing. Participants works on their own and have only technical support.
Internet Based Emotional Awareness and Expression Therapy (I-eaet)
In I-EAET with therapist support, the therapist and participants communicate asynchronous using written messages. The therapist gives feedback each week on home-work assignments and is available on demand for support. In I-EAET without therapist support, the participants works with home-work assignments on their own and only have technical support.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Patient Health Questionnaire -15 (PHQ-15)
Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.
Change from pre to post treatment (after 10 weeks of treatment)
Numeric Rating Scales according to EURONET-SOMA
Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.
Change from pre to post treatment (after 10 weeks of treatment)
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Generalized Anxiety Disorder-7 (GAD-7)
Ratings 0-3 on impact of anxiety symptoms. Higher scores indicates worse symptom/functioning.
Change from pre to post treatment (after 10 weeks of treatment)
Patient Health Questionnaire-9 (PHQ-9)
Ratings 0-3 on impact of depressive symptoms. Higher scores indicates worse symptom/functioning.
Change from pre to post treatment (after 10 weeks of treatment)
Post traumatic stress disorder checklist-5 (PCL-5)
Ratings 0-4 on impact of post traumatic symptoms. Higher scores indicates worse symptom/functioning.
Change from pre to post treatment (after 10 weeks of treatment)
Difficulties in Emotion Regulation Scale-16 (DERS-16)
Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning.
Change from pre to post treatment (after 10 weeks of treatment)
Sheehan Disability Scale (SDS)
Visual analogue scale 0-10 for symptom interference in daily life. Higher scores indicates worse symptom/functioning.
Change from pre to post treatment (after 10 weeks of treatment)
The revised illness perception questionnaire (IPQ-R)
Ratings on illness beliefs.
Change from pre to post treatment (after 10 weeks of treatment)
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • The research subject certifies that he/she has undergone medical assessment for his/her physical symptoms.
  • The subject rates either moderate distress from bodily symptoms in the PHQ-15 (over 10 points) or severe distress from a single bodily symptom (at least 2 points for this symptom).
  • The research participants expresses interest in investigating whether emotional factors such as stress may contribute to symptoms.
  • Research subjects either affirm the presence of emotionally difficult life events (affirm at least 1 such event in the Adverse Childhood Experience (ACE-10) or reach the proposed cut-off point of 23p in the PCL-5).
  • Drugs used should have been stable for at least 1 month.

  • Research subjects suffer from ongoing substance abuse (alcohol or drugs) or are deemed to have serious mental illness (psychotic illness, suicidal ideation, antisocial personality disorder etc).
  • The research subjects have ongoing medication of a clearly addictive and sedative nature (e.g. benzodiazepines).
  • The research subject participates in other psychological treatment focusing on physical symptoms. However, other psychological treatment is allowed where the support therapy does not take place more often than once a month.
  • The research subject does not master the Swedish language sufficiently to be able to assimilate written material in Swedish.
Daniel Maroti logoDaniel Maroti
Wayne State University logoUniversité de Wayne State60 essais cliniques actifs à explorer
Partie responsable de l'essai
Daniel Maroti, Promoteur-Investigateur, PhD, principal investigator, Stockholm University
Aucune donnée de contact disponible
2 Centres de l'essai dans 1 pays
Stockholm University, Stockholm, 10691, Sweden
Daniel Maroti, Med Dr, Contact, +46738028474, [email protected]
En recrutement
Stockholm University, Stockholm, 11419, Sweden
Daniel Maroti, Contact, 0738028474, [email protected]
En recrutement