Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-02-17 @ 7:04 PM
Study NCT ID:
NCT01673035
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2012-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet Treatment for Health Anxiety
Sponsor:
Karolinska Institutet
Organization:
Study Overview
Official Title:
Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HA-X
Brief Summary:
Background
Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.
Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.
Participants in both treatments are expected to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.
Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.
Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.
Participants in both treatments are expected to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.
Detailed Description:
Background
Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.
Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.
The investigators expect participants in both treatments to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.
Design:
Randomized controlled trial. Participants are randomized in a 1:1 ratio.
Assessments:
The primary outcome measure is the Health Anxiety Inventory (HAI). Assessments with HAI are conducted at baseline, post-treatment, 3- and 12 month follow-up.
Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.
Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.
The investigators expect participants in both treatments to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.
Design:
Randomized controlled trial. Participants are randomized in a 1:1 ratio.
Assessments:
The primary outcome measure is the Health Anxiety Inventory (HAI). Assessments with HAI are conducted at baseline, post-treatment, 3- and 12 month follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: