- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06631911
Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study (EAET for PPS)
Emotional Awareness and Expression Therapy (EAET) has emerged as a promising approach for addressing persistent physical symptoms (PPS). Investigating EAET within the context of routine psychiatric care is crucial for several reasons:
Many patients with PPS experience significant distress and functional impairment, yet traditional medical treatments often fail to provide adequate relief. Integrating EAET into routine care could offer a valuable therapeutic option for this population.
Preliminary studies suggest that EAET can lead to significant reductions in pain and other somatic symptoms. Investigating its effectiveness in routine care settings could enhance treatment outcomes for patients who have not responded to conventional therapies.
There is often a disconnect between mental health and physical health treatment in routine care. Investigating EAET can help bridge this gap, fostering collaboration between mental health professionals and primary care providers to address the complexities of patients' health issues.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 10691
- Stockholm University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The participant certifies that they have undergone a medical assessment for their physical symptoms (see separate certificate).
- The participant rates either moderate distress from physical symptoms on the PHQ-15 questionnaire (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom).
- The participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile.
- Any prescribed medications must have been stable for at least one month.
Exclusion Criteria:
- Participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.).
- Participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines).
- Participants are involved in other psychological treatments focused on physical symptoms. However, other psychological treatments are permitted as long as the supportive therapy does not occur more than once a month.
- Participants do not have sufficient proficiency in the Swedish language.
Please note that it is the chief physician of each respective research sponsor who, based on collected anamnesis and self-assessment information, makes the final decision regarding whether a participant should be included or excluded from the research project.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Emotional Awareness and Expression Therapy
Please see description for intervention
|
Emotional Awareness and Expression Therapy (EAET) is a manualized, short-term psychodynamic therapy that, in this instance, is delivered in a group format. The core of Emotional Awareness and Expression Therapy (EAET) involves helping individuals identify, understand, and express their emotions in a therapeutic setting. The therapy emphasizes the connection between unprocessed emotions and physical symptoms, encouraging participants to explore the emotional underpinnings of their distress. Through guided discussions, psychoeducation, and expressive exercises, participants learn to recognize patterns of emotional avoidance, develop self-compassion, and improve interpersonal communication. This process aims to reduce somatic symptoms and enhance overall emotional well-being by fostering a greater awareness of emotional experiences. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-15 (PHQ-15)
Time Frame: Pre-post treatment (at treatment termination)
|
Somatic symptom severity during the "last week " are assessed with the Patient Health Questionnaire-15 (PHQ-15).
Items are rated 0 ("not bothered at all"), 1 ("bothered a little"), or 2 ("bothered a lot"); total scores range from 0 to 30.
|
Pre-post treatment (at treatment termination)
|
|
Visual Analoge Scales
Time Frame: Pre-post treatment (at treatment termination)
|
A second primary outcome is the two Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017).
Somatic symptom intensity is measured from 1 ("No symptom") to 10 ("Symptom as bad as you can imagine") and somatic symptom interference from 1 ("No interference") to 10 ("Maximum interference").
|
Pre-post treatment (at treatment termination)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sheehan Disability Scale
Time Frame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
|
SDS consist on three visual analogue scales ranging from 0-10 for symptom interference in daily life.
Higher scores indicate worse symptom/functioning, with a maximum score of 30.
|
1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
|
|
Post traumatic symptom Check List-5 (PCL-5),
Time Frame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
|
PCL-5 consists of 20 questions with ratings 0-4 on impact of post traumatic symptoms.
Higher scores indicate worse symptom/functioning with a maximum score of 80.
|
1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
|
|
Patient Health Questionaire-9 (PHQ-9)
Time Frame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
|
PHQ-9 consists of nine questions withs ratings 0-3 (0= "not at all", 3= "almost every day") on impact of depressive symptoms.
Higher scores indicate worse symptom/functioning with a maximum score of 27.
|
1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
|
|
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time Frame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
|
GAD-7 consists of seven questions with ratings 0-3 (0= "not at all", 3= "almost every day") on impact of anxiety symptoms.
Higher scores indicate worse symptom/functioning functioning with a maximum score of 21.
|
1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
|
|
Visual Analoge Scales
Time Frame: Pre-FU (12 weeks after intervention)
|
Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017).
Somatic symptom intensity is measured from 1 ("No symptom") to 10 ("Symptom as bad as you can imagine") and somatic symptom interference from 1 ("No interference") to 10 ("Maximum interference").
|
Pre-FU (12 weeks after intervention)
|
|
Patient Health Questionaire-15 (PHQ-15)
Time Frame: Pre-FU (12 weeks after intervention)
|
Somatic symptom severity during the "last week" was assessed with the PHQ-15.
Items were rated 0 ("Not bothered at all"), 1 ("Bothered a little"), or 2 ("Bothered a lot"); total scores range from 0 to 30 for women and 0-27 for men.
|
Pre-FU (12 weeks after intervention)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Credibility and Expectancy Questionaire (CEQ)
Time Frame: Three weeks into treatment
|
The questionnaire consists of several items that participants respond to on a Likert scale (e.g., from 1 to 7), where they rate their level of agreement or belief regarding various statements related to the treatment's credibility and their expected outcomes.
|
Three weeks into treatment
|
|
Negative Effects Questionnaire (NEQ)
Time Frame: At FU (12 weeks after intervention).
|
The questionnaire includes a series of statements or questions that participants respond to using a Likert scale, where they indicate how often they have experienced these negative effects.
|
At FU (12 weeks after intervention).
|
|
8 visual analgue scales
Time Frame: Mediational measure: Every week during the 12 week long treatment (i.e. 11 measurement points.)
|
2 question on 1-10 on symptom intensity and inferference 2 questions on 1-10 on the capacity of self-compassion 2 questions on 1-10 on the capacity of emotional processing 2 question on 1-10 on symptom attribution
|
Mediational measure: Every week during the 12 week long treatment (i.e. 11 measurement points.)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Maroti, PhD, Department of Psychology, Faculty of Social Sciences, Stockholm University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EAET for PPS: a pilot study
- 1111 (Other Grant/Funding Number: Prima Psychiatry internal research fund)
- 5631 (Other Identifier: Signe and Ane Gyllenbergs foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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