Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care (TAYLOR2)
Primary Purpose
Depression, Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tailored Internet-based CBT for depression and anxiety
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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)
Sites / Locations
- Linköping University, Department of Behavioral Sciences and Learning
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tailored Internet-delivered CBT
Arm Description
The intervention is delivered within a primary care clinic.
Outcomes
Primary Outcome Measures
Patient Health Questionnaire 9 (PHQ-9)
Patient Health Questionnaire 9 (PHQ-9)
Patient Health Questionnaire 9 (PHQ-9)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01591720
Brief Title
Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care
Acronym
TAYLOR2
Official Title
Effectiveness Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression, Anxiety and Comorbid Problems
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored Internet-delivered CBT
Arm Type
Experimental
Arm Description
The intervention is delivered within a primary care clinic.
Intervention Type
Behavioral
Intervention Name(s)
Tailored Internet-based CBT for depression and anxiety
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire 9 (PHQ-9)
Time Frame
2 weeks before treatment starts
Title
Patient Health Questionnaire 9 (PHQ-9)
Time Frame
Weekly measures during treatment (for up to 16 weeks)
Title
Patient Health Questionnaire 9 (PHQ-9)
Time Frame
At treatment termination (after a maximum of 16 weeks)
Title
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Time Frame
2 weeks before treatment starts
Title
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Time Frame
Weekly measures during treatment (for up to 16 weeks)
Title
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Time Frame
At treatment termination (after a maximum of 16 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Andersson, PhD
Organizational Affiliation
Department of Behavioral Sciences and Learning, Linköping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University, Department of Behavioral Sciences and Learning
City
Linköping
ZIP/Postal Code
58183
Country
Sweden
12. IPD Sharing Statement
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Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care
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