Clinical trial NCT05446766: Feasibility Evaluation of a Self-guided Exposure-based Digital Intervention for Health Anxiety
Official title: Feasibility Evaluation of a Self-guided Exposure-based Digital Intervention for Health Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Illness Anxiety Disorder
Somatic Symptom Disorder
Keywords: Self-guided intervention
Self-help
Digital intervention
Exposure therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2022-07-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates the feasibility and preliminary efficacy of a self-guided, exposure-based intervention for individuals who suffer from severe health anxiety. The study is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 20-25 adults with DSM-5 Illness anxiety disorder or Somatic symptom disorder are enrolled in 8 weeks of unguided exposure-based treatment via the Internet. Outcomes include self-reported health anxiety symptoms, credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events.

Detailed description: Background

Severe health anxiety (Corresponding to a DSM-5-diagnosis of Illness anxiety disorder or somatic symptom disorder) is a condition associated with high distress, disability and increased health service utilization. Therapist guided Internet delivered cognitive behavioural therapy (ICBT) is efficacious in the treatment of severe health anxiety and has the advantage of requiring less treatment support per patient compared to traditional CBT, thus making the treatment more cost effective. Despite this, the access to ICBT is limited as it requires the active participation of a therapist. Given the relatively high prevalence of individuals experiencing excessive health anxiety, there is need for research on more accessible treatment options.

Unguided self-care interventions have the potential to improve access to treatment and increase cost-effectiveness and have a more immediate scalability. Also, unguided interventions have the advantage of being more easily disseminated outside the traditional mental health care systems and thus, have the potential to reach patients with subclinical, yet distressful, health anxiety.

Aim

The overall aim of this study is to develop a new internet-delivered CBT program based on exposure and response prevention - without therapist support - for patients with severe health anxiety and to examine its feasibility and potential clinical efficacy.

Design

This is a prospective single-group feasibility study with a pre-post design where a total of 25 participants with Illness anxiety disorder or Somatic symptom disorder (suffering from health anxiety) according to the Diagnostic and statistical manual of mental disorders 5 (DSM-5) are enrolled in an 8 weeks unguided internet based treatment targeting exposure and response prevention. The study will evaluate patient-reported satisfaction, engagement and adherence to treatment protocol, credibility, safety and pre-post changes in health anxiety.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* A principal diagnosis Illness anxiety disorder or somatic symptom disorder (DSM-V)
* Access to a computer and the internet
* No serious medical illness
* Participants on psychotropic medication must have been on a stable dose for the last 4 weeks prior to baseline assessment

Exclusion Criteria:

* Difficulties to read or write that makes it hard to understand the content of the intervention
* Currently receiving similar psychological treatment for anxiety
* High risk of suicide
* Diagnosed with psychosis disorder or bipolar disorder
* Ongoing substance dependence
* Have an urgent need for more intensive psychiatric care

Primary outcomes:
measure: Change in Health anxiety symptoms
timeFrame: pre-treatment assessment to 12 weeks after post-treatment assessment
measure: Adherence to the treatment: amount of exposures
timeFrame: Post-treatment assessment (immediately after treatment)
measure: Adherence to the treatment: number of modules
timeFrame: Post-treatment assessment (immediately after treatment)
measure: Adherence to the treatment: types of exposure
timeFrame: Post-treatment assessment (immediately after treatment)
measure: Unintended treatment effects
timeFrame: Post-treatment assessment (immediately after treatment)
measure: Satisfaction with treatment
timeFrame: Post-treatment assessment (immediately after treatment)
Secondary outcomes:
measure: Change in Health anxiety symptoms
timeFrame: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
measure: Change in Health anxiety symptoms
timeFrame: pre-treatment assessment to 4 weeks after post-treatment assessment
measure: Change in depressive symptoms
timeFrame: pre-treatment assessment to12 weeks after post-treatment assessment
measure: Change in depressive symptoms
timeFrame: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
measure: Change in depressive symptoms
timeFrame: pre-treatment assessment to 4 weeks after post-treatment assessment
measure: Change in diagnostic status
timeFrame: Change from baseline interview to 12 weeks after post-treatment assessment
measure: Change in anxiety symptoms
timeFrame: pre-treatment assessment to 12 weeks after post-treatment assessment
measure: Change in anxiety symptoms
timeFrame: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
measure: Change in anxiety symptoms
timeFrame: pre-treatment assessment to 4 weeks after post-treatment assessment
measure: Change in life quality
timeFrame: pre-treatment assessment to 12 weeks after post-treatment assessment
measure: Change in life quality
timeFrame: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
measure: Credibility/expectancy
timeFrame: week 3 of treatment
measure: Usability
timeFrame: Post-treatment assessment (immediately after treatment)
measure: Experience with the program
timeFrame: Post-treatment assessment (immediately after treatment)
measure: Post-treatment adherence to exposure exercises
timeFrame: 12 weeks after post-treatment assessment
Other outcomes:
measure: Telephone interview
timeFrame: immediately after treatment
Locations:
city: Stockholm
country: Sweden
facility: Centrum för Psykiatriforskning
Study officials:
References: