Exposure Therapy vs. Standardized Education for Distress Related to Somatic Symptoms

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    160
  • sponsor
    Region Stockholm
Updated on 27 July 2021

Summary

The annual societal cost of medically unexplained symptoms in Sweden is approximately 40 billion SEK, i.e., similar to the annual cost of cancer. Prevalent chronic diseases like asthma and diabetes are also commonly associated with somatic symptoms that lead to significant distress and pervasive behavioral changes that result in functional impairment and place added strain on the health care system. Exposure-based treatment, where the patient willingly engages with stimuli that give rise to unwanted physical sensations or distress, has shown promise in reducing somatic symptom load and increasing quality of life in several conditions where patients commonly report substantial distress related to somatic symptoms, such as in asthma, musculoskeletal pain, and functional gastrointestinal syndromes. In routine care, however, access to such exposure-based treatment is limited. One reason for this is probably that there exists no flexible exposure-based treatment protocol that can be easily tailored to suit a wide spectrum of patient groups who suffer from distress related to recurrent somatic symptoms. In a recent single group feasibility trial (N=33) at Karolinska Institutet, Sweden, the investigators found that such a tailored exposure-based treatment delivered in an online text-based format can be acceptable, with high treatment adherence, adequate treatment satisfaction, large and lasting within-group improvement, and no serious adverse events. This is a randomized controlled trial (N=160) where the investigators aim to test if the same tailored internet-delivered exposure-based treatment is more efficacious than a standardized education control for adult patients with clinically significant distress related to somatic symptoms in a primary care setting. Primary outcome is change in self-rated somatic symptom burden as modelled using linear mixed models fitted on weekly Patient Health Questionnaire 15 sum scores over the treatment period. Long-term efficacy is assessed up to one year after treatment and cost-effectiveness is investigated based on the incremental cost-effectiveness ratio.

Description

Approximately one fifth of primary care patients seek care for symptoms that cannot readily be given a medical explanation. In addition, primary care is tasked with offering care for prevalent chronic diseases such as asthma and diabetes where somatic symptoms often lead to distress and pervasive behavioral changes. Though a concern with somatic symptoms can be fully warranted, helpful, and transient, it can also be persistent and lead to much unnecessary suffering. Existing treatments commonly yield insufficient effects on medically unexplained symptoms.

Psychological factors - in particular the preoccupation with symptoms - have been found to affect the perception and intensity of a large number of physical symptoms, both with and without a clear medical genesis. In pain, it has for example been found that fear and the preoccupation with symptoms can have a more substantial predictive value for chronicity than pain itself. In general, in individuals who suffer from clinically significant symptom preoccupation, behaviors intended to evaluate symptoms, seek information about symptoms, or avoid discomfort have been found to often contribute to worsened function and increased symptom burden in the long term.

This makes exposure, where the patient willingly and systematically approaches stimuli that give rise to unwanted symptoms or discomfort while refraining from acting on symptoms, a logical intervention. There are several examples where exposure-based treatment has been found to be efficacious when protocols were written to suit a particular group of patients where distress associated with somatic symptoms is common, e.g., a particular functional somatic syndrome in terms of fibromyalgia and irritable bowel syndrome, or a chronic somatic condition such as asthma or atrial fibrillation. Typically, effects on symptoms and the preoccupation with symptoms have been large, and there is evidence to suggests that a reduction in somatic symptom burden may have been mediated by a reduction in symptom preoccupation or behaviors that serve to reduce distress in the short term.

Generalist primary care clinics typically do not have the resources necessary for administering specific psychological treatments for a large number specific functional somatic syndromes or chronic somatic conditions. The investigators suspect that a more general treatment protocol that can be tailored to suit a wide spectrum of physical symptoms could dramatically improve access to exposure-based treatment for patients with distress related to somatic symptoms. This may be particularly true if treatment can be delivered via the internet, which requires less therapist time but often results in similar effects as face-to-face treatment.

The investigators recently completed a feasibility trial at Karolinska Institutet, Sweden (NCT04511286), where the investigators found that an internet-delivered flexible exposure-based treatment for individuals with high levels of symptom preoccupation regardless of somatic symptom domain (N=33; e.g., functional gastrointestinal symptoms, atrial fibrillation, migraine) can be delivered with high treatment adherence, adequate client satisfaction, large and lasting improvement in self-reported somatic symptoms and symptom preoccupation, and no serious adverse events. It is thus motivated to evaluate this treatment format further.

In further evaluating the flexible exposure-based treatment approach for patients with distress related to somatic symptoms it is imperative to conduct a randomized controlled trial versus an informative control condition, focusing on effects on somatic symptoms and symptom preoccupation. It is also important to evaluate if the treatment can be effective in a routine clinical setting and when patients are referred via a clinician such as a general practitioner. In this trial, the investigators aim to evaluate if flexible internet-delivered exposure-based treatment is more effective than an internet-delivered standardized routine care education program for patients with distress related to somatic symptoms in primary care.

  • Primary research question:

Compared to the control condition, does flexible internet-delivered exposure-based treatment lead to a larger average improvement in self-rated somatic symptom burden as assessed using the Patient Health Questionnaire 15 (PHQ-15)? Hypothesis: Yes.

  • Key secondary research questions:

Compared to the control condition, does flexible internet-delivered exposure-based treatment lead to a larger average improvement in symptom preoccupation, psychiatric symptom burden, and functional impairment? Hypothesis: Yes.

In flexible internet-delivered exposure-based treatment, are effects typically maintained up to 12 months after treatment? Hypothesis: Yes.

Is flexible internet-delivered exposure-based treatment cost-effective compared to the control condition? Hypothesis: Yes.

Is the controlled effect of the flexible exposure-based treatment on self-rated somatic symptoms moderated by baseline symptoms and preoccupation? Hypothesis: Yes.

Is the effect of the flexible exposure-based treatment on self-rated somatic symptom burden mediated by a reduction in symptom preoccupation? Hypothesis: Yes.

Details
Condition somatic symptoms, Somatic Symptom and Related Disorders, Psychological Factors Affecting Other Medical Conditions
Treatment Exposure, Standardized education, Prolonged assessment
Clinical Study IdentifierNCT04942028
SponsorRegion Stockholm
Last Modified on27 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

(i) Either much bothered by at least one somatic symptom (2 points on at least one item of the PHQ-15) or at least a moderate overall somatic symptom burden (PHQ-15 sum 10), with (ii) recurrent distress related to somatic symptoms 4 months
Interested in completing an intense psychological treatment with the aim of reducing distress associated with physical symptoms
Adult (18 years old)
Living in Stockholm County
Can read and write in Swedish
Complete baseline assessment

Exclusion Criteria

Symptoms best explained by, or clinical picture dominated by, severe health anxiety or a non-somatoform psychiatric disorder such as depression, panic disorder, primary insomnia, a chronic stress disorder, or an acute stress disorder
Severe psychiatric condition or suicidal ideation
Clear medical risk in taking part in exposure-based treatment (e.g., pregnancy) or somatic condition (e.g., recent cancer diagnosis), or treatment for somatic condition (e.g., recent chemotherapy), makes treatment unfeasible
Continuous psychotropic medication (antidepressants, anticonvulsants, mood-stabilizers, antipsychotics) not stable in past 4 weeks, or not expected to remain stable over the main phase of the trial
Severe alcohol or substance use disorder likely to interfere with treatment
Planned absence for more than 1 week during the intended main phase
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note