Illness Anxiety DisorderNCT05446766
Feasibility Evaluation of a Self-guided Exposure-based Digital Intervention for Health Anxiety
A study testing Self-guided Exposure-based Digital Intervention for Health Anxiety in people with Illness Anxiety Disorder and Somatic Symptom Disorder, run by Karolinska Institutet at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Illness Anxiety Disorder, Somatic Symptom Disorder
- What is being tested?
- Self-guided Exposure-based Digital Intervention for Health Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 6 Sep 2022to 29 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Illness Anxiety Disorder, Somatic Symptom Disorder
- Being tested
- Self-guided Exposure-based Digital Intervention for Health Anxiety
- Keywords
- Self-guided intervention, Self-help, Digital intervention, Exposure therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided Exposure-based Digital Intervention for Health AnxietyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-guided Exposure-based Digital Intervention for Health Anxiety | Experimental | Eight weeks of self-guided exposure-based intervention delivered digitally, via the Internet. Receives: Behavioral: Self-guided Exposure-based Digital Intervention for Health Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-treatment assessment to 12 weeks after post-treatment assessment
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.
Measured: Post-treatment assessment (immediately after treatment)
Adherence to the treatment: number of modules
Will be determined by the number of modules completed by the participants.
Measured: Post-treatment assessment (immediately after treatment)
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.
Measured: Post-treatment assessment (immediately after treatment)
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.
Measured: Post-treatment assessment (immediately after treatment)
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.
Measured: Post-treatment assessment (immediately after treatment)
Secondary outcomes (15)
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.
Measured: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
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.
Measured: pre-treatment assessment to 4 weeks after post-treatment assessment
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.
Measured: pre-treatment assessment to12 weeks after post-treatment assessment
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.
Measured: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
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.
Measured: pre-treatment assessment to 4 weeks after post-treatment assessment
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.
Measured: Change from baseline interview to 12 weeks after post-treatment assessment
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.
Measured: pre-treatment assessment to 12 weeks after post-treatment assessment
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.
Measured: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
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.
Measured: pre-treatment assessment to 4 weeks after post-treatment assessment
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.
Measured: pre-treatment assessment to 12 weeks after post-treatment assessment
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.
Measured: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
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.
Measured: week 3 of treatment
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.
Measured: Post-treatment assessment (immediately after treatment)
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.
Measured: Post-treatment assessment (immediately after treatment)
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".
Measured: 12 weeks after post-treatment assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start6 Sep 2022
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Illness Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Martin Kraepelien, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446766
- Sponsor's protocol ID
- HEALTHANXIETY1
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will be available upon reasonable request.
Publications
Osterman S, Hentati A, Forsell E, Axelsson E, Hedman-Lagerlof E, Lindefors N, Ivanov VZ, Kraepelien M. Brief digital self-care intervention for health anxiety in a Swedish Medical University Clinic: a prospective single-group feasibility study. BMJ Open. 2023 Dec 21;13(12):e077376. doi: 10.1136/bmjopen-2023-077376.
PubMed 38135329
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of a Self-guided Exposure-based Digital Intervention for Health Anxiety
- ClinicalTrials.gov ID
- NCT05446766
- Acronym / sponsor ID
- HEALTHANXIETY1
- Conditions
- Illness Anxiety Disorder, Somatic Symptom Disorder
- Keywords
- Self-guided intervention, Self-help, Digital intervention, Exposure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-guided Exposure-based Digital Intervention for Health Anxiety | Experimental | Behavioral: Self-guided Exposure-based Digital Intervention for Health AnxietyEight weeks of self-guided exposure-based intervention delivered digitally, via the Internet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-guided Exposure-based Digital Intervention for Health AnxietyAn 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. | Behavioural | Self-guided Exposure-based Digital Intervention for Health Anxiety |
Primary outcome
Change in Health anxiety symptoms
Time frame: pre-treatment assessment to 12 weeks after post-treatment assessment
The Short health anxiety inventory - 14 item (SHAI-14). Higher scores indicate greater severity of health anxiety. Scores range from 0 to 42.
Adherence to the treatment: amount of exposures
Time frame: Post-treatment assessment (immediately after treatment)
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.
Adherence to the treatment: number of modules
Time frame: Post-treatment assessment (immediately after treatment)
Will be determined by the number of modules completed by the participants.
Adherence to the treatment: types of exposure
Time frame: Post-treatment assessment (immediately after treatment)
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.
Unintended treatment effects
Time frame: Post-treatment assessment (immediately after treatment)
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.
Satisfaction with treatment
Time frame: Post-treatment assessment (immediately after 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.
15 secondary outcomes
Change in Health anxiety symptoms
Time frame: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
Change in Health anxiety symptoms
Time frame: pre-treatment assessment to 4 weeks after post-treatment assessment
Change in depressive symptoms
Time frame: pre-treatment assessment to12 weeks after post-treatment assessment
Change in depressive symptoms
Time frame: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
Change in depressive symptoms
Time frame: pre-treatment assessment to 4 weeks after post-treatment assessment
Change in diagnostic status
Time frame: Change from baseline interview to 12 weeks after post-treatment assessment
Change in anxiety symptoms
Time frame: pre-treatment assessment to 12 weeks after post-treatment assessment
Change in anxiety symptoms
Time frame: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
Change in anxiety symptoms
Time frame: pre-treatment assessment to 4 weeks after post-treatment assessment
Change in life quality
Time frame: pre-treatment assessment to 12 weeks after post-treatment assessment
Change in life quality
Time frame: pre-treatment assessment to Post-treatment assessment (immediately after treatment)
Credibility/expectancy
Time frame: week 3 of treatment
Usability
Time frame: Post-treatment assessment (immediately after treatment)
Experience with the program
Time frame: Post-treatment assessment (immediately after treatment)
Post-treatment adherence to exposure exercises
Time frame: 12 weeks after post-treatment assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 38135329Osterman S, Hentati A, Forsell E, Axelsson E, Hedman-Lagerlof E, Lindefors N, Ivanov VZ, Kraepelien M. Brief digital self-care intervention for health anxiety in a Swedish Medical University Clinic: a prospective single-group feasibility study. BMJ Open. 2023 Dec 21;13(12):e077376. doi: 10.1136/bmjopen-2023-077376.
- Individual participant dataSharing planned: No. Individual data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-guided Exposure-based Digital Intervention for Health Anxiety in people with Illness Anxiety Disorder and Somatic Symptom Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health anxiety symptoms (time frame: pre-treatment assessment to 12 weeks after post-treatment assessment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.