Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| internet-based CBT | Experimental | Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided |
|
| internet-based BSM | Active Comparator | behavioral stress management delivered via the internet: 12 weeks, therapist-guided |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT, exposure and response prevention | Behavioral | This intervention entails different exercises aimed exposure to health anxiety stimuli. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health Anxiety Inventory (HAI) | Change in HAI at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Illness attitude scale (IAS) | Change in IAS at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up |
| Whiteley Index (WI) |
| Measure | Description | Time Frame |
|---|---|---|
| psychological mediators | Assessment of whether these mediators will precede change in outcome during the treatment | week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erik Hedman, phd | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | Stockholm County | 17177 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27113231 | Derived | Hedman E, Andersson E, Ljotsson B, Axelsson E, Lekander M. Cost effectiveness of internet-based cognitive behaviour therapy and behavioural stress management for severe health anxiety. BMJ Open. 2016 Apr 25;6(4):e009327. doi: 10.1136/bmjopen-2015-009327. | |
| 25104835 | Derived | Hedman E, Axelsson E, Gorling A, Ritzman C, Ronnheden M, El Alaoui S, Andersson E, Lekander M, Ljotsson B. Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2014 Oct;205(4):307-14. doi: 10.1192/bjp.bp.113.140913. Epub 2014 Aug 7. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006998 | Hypochondriasis |
| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BSM, stress management and applied relaxation | Behavioral | BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation. |
|
Change in WI at post-treatment and follow-ups compared to baseline
| baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up |
| Montgomery Åsberg depression rating scale-self report (MADRS-S) | Change in MADRS-S at post-treatment and follow-ups compared to baseline. | baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up |
| Beck Anxiety Inventory (BAI) | Change in BAI at post-treatment and follow-ups compared to baseline. | baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up |
| Anxiety Sensitivity Index (ASI) | Change in ASI at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up |
| Insomnia severity index (ISI) | Change in ISI at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up |
| Sheehan disability scale (SDS) | Change in SDS at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12) 6-month follow-up, 12-month follow-up |
| Trimbos and institute of medical technology assessment cost questionnaire (TIC-P) | Change in TIC-P at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up |
| Euroqol-5D (EQ-5D) | Change in EQ-5D)I at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up |
| Obsessive compulsive inventory revised (OCI-R) | Only for assessing the sample on this symptom domain at pre-treatment. | baseline |
| Yale-brown obsessive compulsive scale (YBOCS) | only for assessing the sample on this domain at pre-treatment | Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52 |
| AUDIT (alcohol use) | Change in AUDIT at post-treatment and follow-ups compared to baseline. | baseline, 12 weeks, 6 month follow-up, 12 month follow-up |