Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study

NCT06631911 | Not Yet Recruiting

• 3 other identifiers: EAET for PPS: a pilot study56311111
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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\' health issues.

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

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire-15 (PHQ-15)

  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

  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 Outcomes (6)

• Sheehan Disability Scale

  1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).

• Post traumatic symptom Check List-5 (PCL-5),

  1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).

• Patient Health Questionaire-9 (PHQ-9)

  1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).

• Generalized Anxiety Disorder 7-item scale (GAD-7)

  1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).

• Visual Analoge Scales

  Pre-FU (12 weeks after intervention)

Other Outcomes (3)

• Credibility and Expectancy Questionaire (CEQ)

  Three weeks into treatment

• Negative Effects Questionnaire (NEQ)

  At FU (12 weeks after intervention).

• 8 visual analgue scales

  Mediational measure: Every week during the 12 week long treatment (i.e. 11 measurement points.)

Study Arms (1)

Emotional Awareness and Expression Therapy

OTHER

Please see description for intervention

Behavioral: Emotional Awareness and Expression Therapy (EAET)

Interventions

Emotional Awareness and Expression Therapy (EAET) BEHAVIORAL

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.

Emotional Awareness and Expression Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Maroti: lead

Study Officials

• Daniel Maroti, PhD

  Department of Psychology, Faculty of Social Sciences, Stockholm University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel L A Maroti, PhD

CONTACT

46738028474; daniel.maroti@su.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, principal investigator

Model Details: Pilot study

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share