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| Name | Class |
|---|---|
| Wayne State University | OTHER |
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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-EAET with therapist support | Experimental | 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. |
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| I-EAET without therapist support | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet based Emotional Awareness and Expression Therapy (I-EAET) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Mediational measure: DERS-16 | Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning. | Each week once a week throughout 10 weeks of treatment |
| Mediational measure: PHQ-15 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholm University | Recruiting | Stockholm | 10691 | Sweden |
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| Label | URL |
|---|---|
| Information about study project at Stockholm University | View source |
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Original data shared on demand from other researchers and after approval from Swedish Ethical Review Authority.
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RCT with two treatment arms
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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) |
Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.
| Each week once a week throughout 10 weeks of treatment |
| Mediational measure: PHQ-4 | Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning. | Each week once a week throughout 10 weeks of treatment |
| Stockholm University | Recruiting | Stockholm | 11419 | Sweden |
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