Health AnxietyNCT04921280
Effectiveness of ICBT for Severe Health Anxiety in Clinical Psychiatry.
An observational study of Health Anxiety and Hypochondriasis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care. A longitudinal cohort study will be conducted investigating 400 patients who have received ICBT for severe health anxiety between 2018-2020 in an outpatient… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Health Anxiety, Hypochondriasis, Illness Anxiety Disorder
- What is being tested?
- Internet based Cognitive Behavioural Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 456 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2018to 15 Mar 2021
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients will receive treatment at the Internet Psychiatry Clinic (www.internetpsykiatri.se), Psychiatry Southwest, Karolinska University Hospital Huddinge. Patient can either apply for treatment through self-referral or through referral from primary or psychiatric care. Self-referred patients will register for treatment through a public e-service portal for health care (i.e.Vårdguiden; 1177.se). Prior to treatment, patients will complete an online screening battery of self-report questionnaires and undergo an assessment by psychiatrists, or resident physicians supervised by psychiatrists.
Who may be able to join
- Patients over 16 years of age
- Living in Sweden
- Primary diagnosis of hypochondriasis according to ICD-10
- Able to read and write
- Have access to a computer or other device with an Internet connection
- If on medication, have a stable dose of psychotropic medication for 4 weeks prior to treatment
- Not having other psychiatric difficulties (e.g., ongoing substance abuse or a psychotic syndrome) that makes ICBT an unsuitable intervention
Who cannot join
- Patients with severe depression (clinician rated Montgomery-Asberg Depression Rating Scale- Self-Rated; MADRS-S and/or moderate to high risk of suicide in which monitoring is required
- Patients with low motivation, severe apathy, or difficulty concentrating
- Patients with psychosis
- Patients with untreated drug or alcohol problems
- Patients with reading and/or writing difficulties, including language difficulties;
Trial locations and contacts
1 site in 1 country.
Sweden1 site
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86
Stockholm, 141 86
About this study
Official title: Effectiveness of Internet-based Cognitive Behavior Therapy for Severe Health Anxiety in Clinical Psychiatry.
The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care.
A longitudinal cohort study will be conducted investigating 400 patients who have received ICBT for severe health anxiety between 2018-2020 in an outpatient psychiatric clinic providing Internet-based treatment.
The primary outcome measure will be the Short Health Anxiety Inventory, SHAI, and a within-group design with repeated measures will be used for primary analysis.
It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up.
Read the detailed description
Severe health anxiety is a prevalent disorder, leading to considerable distress and is associated with high societal costs. Internet-based cognitive behaviour therapy is a method to improve access to evidence-based psychological treatments and it has shown to be efficacious in the treatment of severe health anxiety in several randomized controlled trials. However, there is limited knowledge of its effectiveness and application in clinical psychiatric care.
The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care.
The investigators will conduct at a cohort-study with a pretest-posttest design investigating consecutively recruited patients from May 2018 to April 2021 in an outpatient psychiatric clinic specialised in delivering ICBT. The treatment content has been successfully tested in previous efficacy studies and will be delivered during 13 weeks. The primary outcome measure will be the gold standard SHAI and a within-group design with repeated measures will be used in the primary analysis. It is estimated that 400 patients will receive treatment during this period and thus be included in the study, if consenting.
It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up. The effect size is expected to be somewhat smaller than in research trials but still moderate to large (d > 0.5).
- Conditions
- Health Anxiety, Hypochondriasis, Illness Anxiety Disorder, Somatic Symptom Disorder, Severe Health Anxiety, Hypochondriacal Disorder, Unspecified
- Being tested
- Internet based Cognitive Behavioural Therapy
- Medical subject headings
- Hypochondriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based Cognitive Behavioural TherapyBehavioural
The treatment program consists of 12 chapters or "modules" spread over 12 weeks and contains written information, different exercises and weekly homework assignment. Patients get access to the CBT program via an internet portal and they have weekly contact with a licenced psychologist via encrypted email. Focus of the therapist support is to review the content of the weekly module, reinforce progress and engagement in therapy and assist with treatment difficulties. If needed, therapist can contact patients via telephone. Patients receive weekly reminders via SMS to login to the portal and fill out self-report measures.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Patients who have received treatment for severe health anxiety at the Internet Psychiatry Clinic, Psychiatry Southwest, Karolinska University Hospital Huddinge between April 2018 to April 2021. Receives: Behavioral: Internet based Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The short health anxiety inventory, SHAI
A 14-item self-report measure of health anxiety severity. Total scores on the scale range from 0 to 42 with higher scores indicating a worse outcome (more severe symptoms of health anxiety).
Measured: Change from baseline (week 0) to post-treatment (week 12)
Secondary outcomes (3)
Montgomery Asberg Depression Rating Scale Self Rate, MADRS-S
A 10-item self-report measure of depressive symptoms. Total scores on the scale range from 0 to 54 with higher scores indicating a worse outcome (more severe depressive symptoms).
Measured: Change from baseline (week 0) to post-treatment (week 12)
Generalised Anxiety Disorder 7-item scale, GAD-7
A 7-item self-report measure of general anxiety symptoms. Total scores on the scale range from 0 to 21 with higher scores indicating a worse outcome (more symptoms of general anxiety).
Measured: Change from baseline (week 0) to post-treatment (week 12)
EQ5D
A self-report measure of health-related quality of life.Total scores on the scale range from 0-1 with higher scores indicating a better outcome (more health and life quality). The questionnaire also includes a Visual Analog Scale (VAS) with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Measured: Change from baseline (week 0) to post-treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Apr 2018
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AnxietyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Volen Ivanov, Karolinska Institutet
- Investigators
- Volen Ivanov, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921280
- Sponsor's protocol ID
- 2011/2091-31/3
- Status last verified
- Sep 2021
- First submitted
- 4 May 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Internet-based Cognitive Behavior Therapy for Severe Health Anxiety in Clinical Psychiatry.
- ClinicalTrials.gov ID
- NCT04921280
- Acronym / sponsor ID
- 2011/2091-31/3
- Conditions
- Health Anxiety, Hypochondriasis, Illness Anxiety Disorder, Somatic Symptom Disorder, Severe Health Anxiety, Hypochondriacal Disorder, Unspecified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 10 Jun 2021 (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.
The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care.
A longitudinal cohort study will be conducted investigating 400 patients who have received ICBT for severe health anxiety between 2018-2020 in an outpatient psychiatric clinic providing Internet-based treatment.
The primary outcome measure will be the Short Health Anxiety Inventory, SHAI, and a within-group design with repeated measures will be used for primary analysis.
It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up.
Detailed description
Severe health anxiety is a prevalent disorder, leading to considerable distress and is associated with high societal costs. Internet-based cognitive behaviour therapy is a method to improve access to evidence-based psychological treatments and it has shown to be efficacious in the treatment of severe health anxiety in several randomized controlled trials. However, there is limited knowledge of its effectiveness and application in clinical psychiatric care.
The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care.
The investigators will conduct at a cohort-study with a pretest-posttest design investigating consecutively recruited patients from May 2018 to April 2021 in an outpatient psychiatric clinic specialised in delivering ICBT. The treatment content has been successfully tested in previous efficacy studies and will be delivered during 13 weeks. The primary outcome measure will be the gold standard SHAI and a within-group design with repeated measures will be used in the primary analysis. It is estimated that 400 patients will receive treatment during this period and thus be included in the study, if consenting.
It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up. The effect size is expected to be somewhat smaller than in research trials but still moderate to large (d > 0.5).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Behavioral: Internet based Cognitive Behavioural TherapyPatients who have received treatment for severe health anxiety at the Internet Psychiatry Clinic, Psychiatry Southwest, Karolinska University Hospital Huddinge between April 2018 to April 2021. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients will receive treatment at the Internet Psychiatry Clinic (www.internetpsykiatri.se), Psychiatry Southwest, Karolinska University Hospital Huddinge. Patient can either apply for treatment through self-referral or through referral from primary or psychiatric care. Self-referred patients will register for treatment through a public e-service portal for health care (i.e.Vårdguiden; 1177.se). Prior to treatment, patients will complete an online screening battery of self-report questionnaires and undergo an assessment by psychiatrists, or resident physicians supervised by psychiatrists.
Key inclusion criteria (7 listed)
- Patients over 16 years of age
- Living in Sweden
- Primary diagnosis of hypochondriasis according to ICD-10
- Able to read and write
- Have access to a computer or other device with an Internet connection
Key exclusion criteria (5 listed)
- Patients with severe depression (clinician rated Montgomery-Asberg Depression Rating Scale- Self-Rated; MADRS-S and/or moderate to high risk of suicide in which monitoring is required
- Patients with low motivation, severe apathy, or difficulty concentrating
- Patients with psychosis
- Patients with untreated drug or alcohol problems
- Patients with reading and/or writing difficulties, including language difficulties;
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 |
|---|---|---|
| Internet based Cognitive Behavioural TherapyThe treatment program consists of 12 chapters or "modules" spread over 12 weeks and contains written information, different exercises and weekly homework assignment. Patients get access to the CBT program via an internet portal and they have weekly contact with a licenced psychologist via encrypted email. Focus of the therapist support is to review the content of the weekly module, reinforce progress and engagement in therapy and assist with treatment difficulties. If needed, therapist can contact patients via telephone. Patients receive weekly reminders via SMS to login to the portal and fill out self-report measures. | Behavioural | Treatment group |
Primary outcome
The short health anxiety inventory, SHAI
Time frame: Change from baseline (week 0) to post-treatment (week 12)
A 14-item self-report measure of health anxiety severity. Total scores on the scale range from 0 to 42 with higher scores indicating a worse outcome (more severe symptoms of health anxiety).
3 secondary outcomes
Montgomery Asberg Depression Rating Scale Self Rate, MADRS-S
Time frame: Change from baseline (week 0) to post-treatment (week 12)
Generalised Anxiety Disorder 7-item scale, GAD-7
Time frame: Change from baseline (week 0) to post-treatment (week 12)
EQ5D
Time frame: Change from baseline (week 0) to post-treatment (week 12)
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 29 Sep 2021.
Related trials for Health Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
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.
Volen Ivanov, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Anxiety and Hypochondriasis, 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 7 inclusion and 5 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 29 Sep 2021. 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?
The short health anxiety inventory, SHAI (time frame: Change from baseline (week 0) to post-treatment (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.