Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751825
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2021-02-01
Brief Title:
Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder - A Randomized Controlled Trial
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder - A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBS2
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 stressfultraumatic 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 910
Many of todays 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 1213 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 Cohens d 112 95 CI 077-146 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 231 achieved a 50 or greater reduction in somatic symptoms The treatment also significantly increased patients 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 Schubiners 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 ie 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
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 stressfultraumatic 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 910
Many of todays 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 1213 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 Cohens d 112 95 CI 077-146 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 231 achieved a 50 or greater reduction in somatic symptoms The treatment also significantly increased patients 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 Schubiners 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None