In WHO ICD-11 (its latest edition), the diagnostic criteria for post-traumatic stress disorder (PTSD) were revised, and a new sibling disorder, complex post-traumatic stress disorder (CPTSD) was introduced. CPTSD is a debilitating condition associated with severe, prolonged, or chronic trauma. Refugee populations are affected by high prevalence of CPTSD because of high rates of such trauma (e.g. torture). Untreated CPTSD has negative consequences for quality of life and for integration into the host society. Evidence indicates cultural variation in the phenomenology of CPTSD. Modular approaches, e.g., the Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR/MPE), have been recommended for the treatment of CPTSD. However, they have not been tested in a clinical trial among refugees so far and there are no available publications about their effectiveness in CPTSD symptom reduction among this population. Research suggests a higher symptom reduction of trauma-focused techniques, such as Narrative Exposure Therapy (NET), among refugee population. In a previous study, the investigators pilot tested a version of ESTAIR/NET that was adapted to sociocultural and structural aspects related to psychopathology in refugee populations. The performance of these culturally adapted modules in CPTSD symptom reduction among the refugee population remains to be assessed. The present clinical trial seeks to assess the effect of the culturally adapted modules of the ESTAIR manual on symptom reduction among refugees and asylum seekers diagnosed with CPTSD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
288
ESTAIR is a psychotherapeutic manual for the treatment of CPTSD. The manual was adapted to the target population. It contains 24 sessions which are organised in four modules, including a module about emotion regulation. This module contains exercises for emotional awareness and emotion regulation with different focuses (on body, thoughts and behaviour).
ESTAIR is a psychotherapeutic manual for the treatment of CPTSD. The manual was adapted to the target population. It contains 24 sessions which are organised in four modules, including a module about negative self-concept. In this module, the manual tackles topics such as what is the self, thinking about the self through cognitive restructuring, criticism and compassion and the self in relation to others.
ESTAIR is a psychotherapeutic manual for the treatment of CPTSD. The manual was adapted to the target population. It contains 24 sessions which are organised in four modules, including a module about interpersonal relationships. This module includes exercises to understand relationship patterns, increasing assertiveness, practicing assertiveness, and managing power.
ESTAIR is a psychotherapeutic manual for the treatment of CPTSD. It contains 24 sessions which are organised in four modules. The manual was adapted to the target population. In this context, the module "modified prolonged exposure" was replaced with Narrative Exposure Therapy (NET). NET is a standardised approach for the treatment of PTSD that has been tested across diverse social and cultural contexts. In this intervention, patients and therapists elaborate together a chronological timeline (called "the lifeline") of patient's life and the traumatic events, using a rope, stones for traumatic events, and flowers for positive events. Thereafter, the traumatic events are discussed in detail, one in each session. At the end of each session, patients receive a written form of these narrations, co-signed by patient and the therapist.
Centra
Hamburg, Hamburg, Germany
NOT_YET_RECRUITINGPsychiatrie Basel-Land
Liestal, Basel-Landschaft, Switzerland
RECRUITINGPsy4Asyl
Aarau, Canton of Aargau, Switzerland
RECRUITINGUPK Transkulturelle Ambulanz
Basel, Canton of Basel-City, Switzerland
RECRUITINGSRK Ambulatorium für Folter- und Kriegsopfer
Wabern, Canton of Bern, Switzerland
NOT_YET_RECRUITINGAppartenances - CPM Lausanne
Lausanne, Canton of Vaud, Switzerland
NOT_YET_RECRUITINGAppartenances - CPM Yverdon-les-Bains
Yverdon-les-Bains, Canton of Vaud, Switzerland
NOT_YET_RECRUITINGCPTSD symptom change
CPTSD symptom change will be assessed with the International Trauma Questionnaire (ITQ-28). This questionnaire contains 28 items on symptoms that are self-rated on a Likert scale of 0-4, with a maximum total score of 112.
Time frame: 8 months
Depression
Patient Health Questionnaire (PHQ-9). The PHQ-9 score may range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores mean higher levels of depression.
Time frame: 8 months
Anxiety
General Anxiety Disorder Questionnaire (GAD-7). The GAD-7 score may range from 0 to 21, since each of the 7 items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores mean higher levels of anxiety.
Time frame: 8 months
Somatic symptoms
Somatic Symptoms Scale (SSS-8). The SSS-8 score may range from 0 to 32, since each of the 8 items can be scored from 0 (not at all) to 4 (severely). Higher scores mean higher levels of somatic symptoms.
Time frame: 8 months
Well-being
WHO-5 questionnaire. Scores range from 0-25, with higher scores reflecting higher levels of well-being.
Time frame: 8 months
Dissociative symptoms (Shut-D)
The Shut-D contains 13 items measuring dissociative symptoms such as fainting or analgesia. Each item is rated on a scale from 0 to 3. The total score ranges from 0 to 39.
Time frame: 8 months
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