Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder - A Randomized Controlled Trial

NCT ID: NCT04751825

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-04-15

Brief Summary

The main purpose of this study is to conduct a Randomised Controlled Trial (RCT) where we evaluate an internet administrated version of Emotional Awareness and Expression Therapy (I-EAET) in the treatment of Somatic Symptom Disorder (SSD). We will include 160 patients with SSD that will be randomized to taking part of the Internet based treatment for ten weeks (80 patients) or a waiting list control condition (80 patients). A between-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly for the primary outcome measures (PHQ-15, BPI-4) and the process measure (EPS-25). The other self-report measures will be conducted before, after treatment and at follow up at 4-month and 12.

Detailed Description

Research background Somatic Symptom Disorder (SSD; DSM-5) is one of the most prevalent disorders encountered in primary care settings (1). Typically in SSD, distressing somatic complaints are accompanied by abnormal thoughts, feelings, and behaviors, emphasizing the role of psychological factors. The experience of somatic symptoms is commonly associated with high levels of impairment in quality of life, psychological distress or increased healthcare utilization (2). In addition, SSD has been associated with an elevated risk for chronic manifestation and comorbid mental disorders, work loss or early retirement (3). Although cognitive behavior therapy (CBT) is the best evidenced psychological treatment for SSD, effect sizes are rather moderate or even small (4). Therefore the question of how to develop more effective treatment protocols for SSD arises.

Difficulties in emotional processing and expression have been demonstrated with patients with SSD in several studies (5). Importantly though, there are indications that an emotion focus in treatment increases the possibility of symptom reduction for patients with SSD (6). In addition, many patients with SSD have experienced stressful/traumatic life events (7). Hence, another potential reason for the limited effect of CBT for SSD may be that these traumas have not been adequately addressed in treatment.

Emotional Awareness and Expression Therapy (EAET) is an affect-focused psychodynamic form of psychotherapy, that has an explicit focus on emotional processing and resolving attachment trauma (8). There is a promising research support for EAET for treating SSD related disorders, where it has been shown to be more effective than CBT in two randomized controlled trials where fibromyalgia and chronic musculoskeletal pain were targeted, respectively (9,10).

Many of today's models of psychotherapy has been tested as guided self-help via the Internet (11). This is a cost-effective, scalable form of psychotherapy delivery. While there exists promising evidence that Internet-based affect-focused psychodynamic therapy is effective in the treatment of depression and anxiety disorders (12,13), there are no published studies on EAET in the format of guided self-help delivered via the Internet.

Preliminary results from a pilot study on Internet-based EAET However, our own group very recently completed a (yet unpublished) pilot trial of Internet based EAET (I-EAET), with an explicit focus on emotional processing using expressive writing. The project was approved by the Swedish Ethical Review Authority (Dnr 2019-03317). We included 52 patients with SSD who took part of a nine-week program based on EAET. Details of the I-EAET intervention are described in the Methods sections below. A large within-group reduction in somatic symptoms (PHQ-15) was observed (Cohen's d = 1.12; 95% CI: 0.77-1.46). Small to moderate magnitude reductions in anxiety (GAD-7), depression (PHQ-9), trauma related symptoms (PCL-5), and dysfunctional emotional processing (EPS25) occurred. Almost one-quarter of the sample (23.1%) achieved a 50% or greater reduction in somatic symptoms. The treatment also significantly increased patient's ability to take part in social and family life (Sheehan Disability Scale). The results were maintained at a four month follow-up. While the results are to be interpreted carefully, the effects seem promising. Further research studies on I-EAET using randomized controlled trials are warranted.

This research proposal is about testing the effects of I-EAET in the treatment of SSD, compared to a waiting-list control condition, using a randomized controlled trial. The long term goal is to develop an intervention that can increase treatment optimization in SSD.

Research questions

a) Can Internet-delivered EAET with an explicit focus on expressive writing decrease bodily symptoms and pain, depression, anxiety and insomnia symptoms, among patients with SSD, as compared to a control condition? b) Is symptom reduction throughout treatment of SSD associated with an increase in emotional processing? c) Are the effects maintained at a 4-month- and 12-month follow-up?

Methods The I-EAET intervention was developed as part of the pilot trial, conducted during late 2019. It is primarily based on Howard Schubiner's book "Unlearn your pain" (14). The I-EAET intervention includes 1) a psychoeducational component on the brain and the nervous system, 2) self-compassion training using meditation techniques, 3) awareness practice on the relationship between trauma, emotions and bodily symptoms, 4) emotional processing using expressive writing exercises, and 5) adaptive interpersonal communication in situations that might trigger pain symptoms. The treatment will last 10 weeks. A secure web-platform (the KI e-Health Core Facility) will be used to provide the treatment via the Internet. Every week the participant in the treatment reads a text consisting of 10-20 pages. The text specifies the theme for the week (i.e. self-compassion) and the home-work assignments to be conducted during the week. Typically, the participants do a daily meditation exercise for 10-15 minutes and an expressive writing assignment for 15-30 minutes. In the daily meditation exercises the participant learn to observe self-critical thoughts and to notice that these thoughts sometimes is anger turned at oneself. Using these meditation exercises, the participants learns to develop a compassionate voice instead of their self-critical one. In the written assignments, usually a stressful or traumatic life event is targeted where emotions are processed in a prespecified order. Emotions tied to these situations are often anger, guilt about anger, sadness and love.

When the participants have done the homework for the week, they send it to their designated psychologist and get written feedback.

Randomized controlled trial of Internet-based EAET for SSD The main purpose of this study is to conduct a Randomised Controlled Trial (RCT) where we evaluate an internet administrated version of Emotional Awareness and Expression Therapy (I-EAET) in the treatment of Somatic Symptom Disorder (SSD). We will include 160 patients with SSD that will be randomized to taking part of the Internet based treatment for ten weeks (80 patients) or a waiting list control condition (80 patients). A between-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly for the primary outcome measures (PHQ-15, BPI-4) and the process measure (EPS-25). The other self-report measures will be conducted before, after treatment and at follow up at 4-month and 12.

Feedback on content, process and potential caveats will be collected using surveys and written evaluations from the participants at post-treatment. Linear mixed models will be used to investigate trajectories of change in symptoms and processes.

Time plan January 2021: Recruitment, screening procedure and diagnostic interviews February 2021: Treatment start + Pre-treatment measures conducted April 2021: Treatment ends + Post-treatment measures conducted September 2021: Four-month follow-up + Treatment offered to patients on waiting-list April 2022: Twelve-month follow-up measures

Significance An EAET intervention conducted through the Internet, with a strong focus on emotional processing using expressive writing could potentially increase treatment optimization in SSD and offer a new potential treatment avenue. Furthermore, although several theoretical models of SSD exist, the field lacks solid empirical results from treatment trials, where the analyses of mechanisms of change are conducted using state-of-the-art methods. Such analyses could help to pinpoint the relation between symptom change and emotional processing throughout different phases of treatment.

Ethical considerations Given that the treatment manual in our studies has not been evaluated before, special considerations will be given to adverse effects. As weekly symptom measures will be conducted, we will be able to monitor patients closely for any potential deterioration that will need to be handled. Medical experts will be available for consultation throughout the treatment periods. Adverse events of treatment will also be monitored by using the Negative Effects Questionnaire (NEQ).

Conditions

Somatic Symptom Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I-EAET

Internet administrated Emotional and Awareness and Expression Therapy (I-EAET). 10 weeks. Self-help treatment with therapist contact via text messages at least once a week.

Group Type: EXPERIMENTAL

I-EAET

Intervention Type: BEHAVIORAL

See information in arm description.

WL

Wait-list.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

I-EAET

See information in arm description.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age over 18 years
• A total score ≥5 on the PHQ-15
• A diagnosis of SSD according to the DSM-5, i.e ≥1 of the 3 of: disproportionate thoughts about the somatic symptom, persistently high level of anxiety, or excessive time and energy devoted in regard to symptoms or health concerns
• Symptom duration ≥6 months
• Written statement from a medical professional that states that a medical evaluation has been conducted.

Exclusion Criteria

• Alcohol or substance addiction
• A diagnosis of a psychological condition that might require other treatment (e.g., psychosis, suicidality, etc)
• Other severe medical condition
• Ongoing psychological intervention or psychotherapy that target somatic symptoms
• Ongoing medical treatment that may interfere with the psychological treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stockholm University

OTHER

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Robert Johansson

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Johansson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Insitutet

Locations

Karolinska Institute

Stockholm, , Sweden

Countries

Sweden

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Other Identifiers

KIMBS2

Identifier Type: -

Identifier Source: org_study_id