Feasibility Evaluation of a Self-guided Exposure-based Digital Intervention for Health Anxiety

Somatic Symptom Disorder Clinical Trial

Official title:

Feasibility Evaluation of a Self-guided Exposure-based Digital Intervention for Health Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446766
• Other study ID #: HEALTHANXIETY1
• Status: Completed
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: March 29, 2023

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Illness Anxiety Disorder
• Medically Unexplained Symptoms
• Somatic Symptom Disorder

Intervention

Behavioral:
• Self-guided Exposure-based Digital Intervention for Health Anxiety
An 8-week self-guided internet based CBT intervention which consists of text, exercises, examples and automated support. The format, potentially more accessible compared to traditional ICBT, will be developed with the aim to enhance treatment comprehension and motivation in the participants. The program consists of eight modules (chapters) where the main therapeutic focus is exposure with response prevention. Participant will be interviewed before the program starts, after 8 weeks and 3 months after the program ends. If in need for technical support, participant will be able to ask for assistance via the program and will then be contacted by a clinician via telephone within a couple of days.

Locations

Country	Name	City	State
Sweden	Centrum för Psykiatriforskning	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Telephone interview	A semi-structured interview concerning the experience of the intervention and format will be conducted via telephone	immediately after treatment
Primary	Change in Health anxiety symptoms	The Short health anxiety inventory - 14 item (SHAI-14). Higher scores indicate greater severity of health anxiety. Scores range from 0 to 42.	pre-treatment assessment to 12 weeks after post-treatment assessment
Primary	Adherence to the treatment: amount of exposures	Will be determined by the amount of exposure exercises reported in the program and in a weekly questionnaire. Acceptable level of adherence will be set to at least 50 % of participants working actively with exposure a majority of the days during a week for 4 weeks or more.	Post-treatment assessment (immediately after treatment)
Primary	Adherence to the treatment: number of modules	Will be determined by the number of modules completed by the participants.	Post-treatment assessment (immediately after treatment)
Primary	Adherence to the treatment: types of exposure	Will be determined by the number of different types of exposure exercises performed by participants. At the end of the program, participants will answer yes or no to whether they engaged in each component (type of exposure exercise) of the intervention.	Post-treatment assessment (immediately after treatment)
Primary	Unintended treatment effects	Participants will be asked to state whether they had experienced any negative or unwanted effects of the treatment. If answering 'Yes', participants will be asked to specify the adverse event in free text. Adverse events will primarily be reported as the total number of reported events.	Post-treatment assessment (immediately after treatment)
Primary	Satisfaction with treatment	Client Satisfaction Questionnaire (CSQ-8). Scores range from 8-32 with higher scores indicating greater satisfaction. An average Client Satisfaction Questionnaire-8 score of at least 22 will provide support for the acceptability and feasibility of this intervention.	Post-treatment assessment (immediately after treatment)
Secondary	Change in Health anxiety symptoms	The Short health anxiety inventory - 14 item (SHAI-14). Higher scores indicate greater severity of health anxiety. Scores range from 0 to 42.	pre-treatment assessment to Post-treatment assessment (immediately after treatment)
Secondary	Change in Health anxiety symptoms	The Short health anxiety inventory - 14 item (SHAI-14). Higher scores indicate greater severity of health anxiety. Scores range from 0 to 42.	pre-treatment assessment to 4 weeks after post-treatment assessment
Secondary	Change in depressive symptoms	Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.	pre-treatment assessment to12 weeks after post-treatment assessment
Secondary	Change in depressive symptoms	Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.	pre-treatment assessment to Post-treatment assessment (immediately after treatment)
Secondary	Change in depressive symptoms	Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27.	pre-treatment assessment to 4 weeks after post-treatment assessment
Secondary	Change in diagnostic status	Health Preoccupation Diagnostic Interview (HPDI). HPDI is a structured interview designed to assess Illness anxiety disorder and Somatic symptom disorder according to DSM-V criteria. HPDI will be administered via telephone.	Change from baseline interview to 12 weeks after post-treatment assessment
Secondary	Change in anxiety symptoms	Generalized Anxiety Disorder 7-item scale (GAD-7). Higher total scores indicate greater severity of anxiety symptoms. Scores range from 0 to 21.	pre-treatment assessment to 12 weeks after post-treatment assessment
Secondary	Change in anxiety symptoms	Generalized Anxiety Disorder 7-item scale (GAD-7). Higher total scores indicate greater severity of anxiety symptoms. Scores range from 0 to 21.	pre-treatment assessment to Post-treatment assessment (immediately after treatment)
Secondary	Change in anxiety symptoms	Generalized Anxiety Disorder 7-item scale (GAD-7). Higher total scores indicate greater severity of anxiety symptoms. Scores range from 0 to 21.	pre-treatment assessment to 4 weeks after post-treatment assessment
Secondary	Change in life quality	Brunnsviken Brief Quality of Life Questionnaire (BBQ). A 12-item questionnaire covering six different life domains: leisure time, view on life, creativity, learning, friends and friendship, and view of self. Scores range from 0 to 96, where higher values indicate higher quality of life satisfaction.	pre-treatment assessment to 12 weeks after post-treatment assessment
Secondary	Change in life quality	Brunnsviken Brief Quality of Life Questionnaire (BBQ). A 12-item questionnaire covering six different life domains: leisure time, view on life, creativity, learning, friends and friendship, and view of self. Scores range from 0 to 96, where higher values indicate higher quality of life satisfaction.	pre-treatment assessment to Post-treatment assessment (immediately after treatment)
Secondary	Credibility/expectancy	The five-item version of Credibility/Expectancy Questionnaire (CEQ). The CEQ ranges from 0 to 10 points per item and 0 to 50 points in total, where a higher score reflects better treatment credibility.	week 3 of treatment
Secondary	Usability	The System Usability Scale (SUS). The SUS consists of ten items, with a range of 0-4 points per item. The items are summed up and calculated with a formula resulting in a total score between 0 and 100, with a higher score reflecting better system usability.	Post-treatment assessment (immediately after treatment)
Secondary	Experience with the program	A non-validated questionnaire measuring experience working with the program. The scale comprises four questions where participant answer whether the intervention was perceived as likable, easy to understand, whether examples given felt relevant and whether functionality and information contributed to the participant feeling overwhelmed. Answers will be made on a four-point scale ranging from 0 (strongly disagree) to 3 (strongly agree). It will be optional to add a free-text comment to the responses, as well as suggestions of overall improvements.	Post-treatment assessment (immediately after treatment)
Secondary	Post-treatment adherence to exposure exercises	Adherence to the exposure exercises will be determined by an online questionnaire where participant on a four point Likert scale will state to what extent they have worked with exposure: "not at all", "occasionally", "more than half of the days" and "daily".	12 weeks after post-treatment assessment