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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01591720
Other study ID # GA-VR-DEP-2
Secondary ID
Status Completed
Phase N/A
First received April 18, 2012
Last updated May 2, 2012
Start date September 2010
Est. completion date August 2011

Study information

Verified date May 2012
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial Summary

A tailored Internet-based cognitive-behavioural intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant within-group effects are expected.


Description:

This Internet-based cognitive-behavioural therapy intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.

The intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Symptoms of depression and anxiety

Exclusion Criteria:

- Severe depression (based on interview)

- Severe psychiatric condition (e.g. psychosis or bipolar disorder)

- Suicidal (measured in diagnostic interview)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Tailored Internet-based CBT for depression and anxiety
This Internet-based CBT intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.

Locations

Country Name City State
Sweden Linköping University, Department of Behavioral Sciences and Learning Linköping

Sponsors (1)

Lead Sponsor Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Health Questionnaire 9 (PHQ-9) 2 weeks before treatment starts No
Primary Patient Health Questionnaire 9 (PHQ-9) Weekly measures during treatment (for up to 16 weeks) No
Primary Patient Health Questionnaire 9 (PHQ-9) At treatment termination (after a maximum of 16 weeks) No
Primary Generalised Anxiety Disorder Assessment 7 (GAD-7) 2 weeks before treatment starts No
Primary Generalised Anxiety Disorder Assessment 7 (GAD-7) Weekly measures during treatment (for up to 16 weeks) No
Primary Generalised Anxiety Disorder Assessment 7 (GAD-7) At treatment termination (after a maximum of 16 weeks) No
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