Clinical trial NCT06631911: Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study
Official title: Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Persistent Physical Symptoms (PPS)
Functional Somatic Disorder
Functional Somatic Syndromes
Somatic Symptom Disorder (DSM-5)
Keywords: Emotional Awareness and Expression Therapy
Group psychotherapy
routine care
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

Brief summary: 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\&amp;#39; health issues.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Pre-post treatment (at treatment termination)
measure: Visual Analoge Scales
timeFrame: Pre-post treatment (at treatment termination)
Secondary outcomes:
measure: Sheehan Disability Scale
timeFrame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
measure: Post traumatic symptom Check List-5 (PCL-5),
timeFrame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
measure: Patient Health Questionaire-9 (PHQ-9)
timeFrame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
measure: Visual Analoge Scales
timeFrame: Pre-FU (12 weeks after intervention)
measure: Patient Health Questionaire-15 (PHQ-15)
timeFrame: Pre-FU (12 weeks after intervention)
Other outcomes:
measure: Credibility and Expectancy Questionaire (CEQ)
timeFrame: Three weeks into treatment
measure: Negative Effects Questionnaire (NEQ)
timeFrame: At FU (12 weeks after intervention).
measure: 8 visual analgue scales
timeFrame: Mediational measure: Every week during the 12 week long treatment (i.e. 11 measurement points.)
Locations:
Study officials:
affiliation: Department of Psychology, Faculty of Social Sciences, Stockholm University
name: Daniel Maroti, PhD
role: PRINCIPAL_INVESTIGATOR
References: