An interventional study of Self-guided Exposure-based Digital Intervention for Health Anxiety in Illness Anxiety Disorder and Somatic Symptom Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's enrollment of 25 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.
Browse Medically Unexplained Symptoms studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eight weeks of self-guided exposure-based intervention delivered digitally, via the Internet.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 12 weeks after post-treatment assessment
Telephone interview
A semi-structured interview concerning the experience of the intervention and format will be conducted via telephone
Time frame: immediately after treatment
Plan to share: No — Individual data will be available upon reasonable request.
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Mar 2023, 6 months.
Of 33 non-industry interventional studies with no phase under Medically Unexplained Symptoms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 6 months is below that.
Counting every sponsor, half of 33 studies reached it within 29 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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