Effectiveness of ICBT for Severe Health Anxiety in Clinical Psychiatry.

Somatic Symptom Disorder Clinical Trial

Official title:

Effectiveness of Internet-based Cognitive Behavior Therapy for Severe Health Anxiety in Clinical Psychiatry.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04921280
• Other study ID #: 2011/2091-31/3
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: March 15, 2021

Study information

• Verified date: September 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Health Anxiety
• Hypochondriasis
• Illness Anxiety Disorder
• Medically Unexplained Symptoms
• Severe Health Anxiety
• Somatic Symptom Disorder

Intervention

Behavioral:
• Internet based Cognitive Behavioural Therapy
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.

Locations

Country	Name	City	State
Sweden	M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86	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
Primary	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).	Change from baseline (week 0) to post-treatment (week 12)
Secondary	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).	Change from baseline (week 0) to post-treatment (week 12)
Secondary	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).	Change from baseline (week 0) to post-treatment (week 12)
Secondary	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).	Change from baseline (week 0) to post-treatment (week 12)