- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02112266
Depression Online Assessment and Therapy
May 9, 2016 updated by: University of Zurich
Online Assessment for Therapy Expectation and Quality of Life and Online Therapy of Depression
One Aim of the current study is to better understand why some patients suffering from depression do not seek professional help by doctors but in the internet.
Furthermore patients with depression will receive Online Therapy for depression. Aim of this part of the study is to investigate whether quality of life changes accordingly to improvement of symptoms after online therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- German speaking patients can register online. There will be no side visits.
- After screening: patients which meet inclusion criteria and no exclusion criteria can take part in online therapy for depression.
- After 12 weeks 2nd online survey. After this survey patients can use the program the following 6 months (follow-up)
- After 6 months 3rd and last online-survey.
- According to the aims of the study cross-sectional as well as longitudinal data will be obtained and analysed
Study Type
Interventional
Enrollment (Actual)
272
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zurich, Switzerland, 8091
- University Hospital Zurich - only online recruitment
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- German language
- depression at least slight according BDI (Beck depression inventory) and at least 2 weeks
Exclusion Criteria:
- severe depression according BDI
- suicidal ideation
- alcohol or drug dependency
- history of psychotic symptoms
- history of bipolar disorder or previous mania
- current in-patient care or semi-residential treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: no mail support
no mail support during follow-up
|
follow-up without mail support
|
Other: mail support
|
between post treatment and follow up two groups: one with unspecific mail support every 2 weeks one without
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Quality of life
Time Frame: at screening, post treatment (3 months) and follow-up (6 months after post)
|
WHOQol brev - WHO quality of life questionnaire short form
|
at screening, post treatment (3 months) and follow-up (6 months after post)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of Sleep quality
Time Frame: screening, post treatment (3 months), follow-up(6 months after post)
|
Questionnaire PSQI - Pittsburgh sleep quality index
|
screening, post treatment (3 months), follow-up(6 months after post)
|
change of severity of depression
Time Frame: 3 time points screening, + 3 months + 6 months
|
patients receive mail support or not during follow up.
Questionnaire: BDI - Beck Depression Inventory
|
3 time points screening, + 3 months + 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of therapy expectation during online-therapy
Time Frame: 3 time points screening + 3 months + 6 months
|
therapy expectation at screening and after intervention.
Questionnaire: PECHI - Psychotherapy Expectations, Concerns, and Hopes Inventory
|
3 time points screening + 3 months + 6 months
|
alexithymia
Time Frame: screening
|
influences on outcome?
Questionnaire: TAS - Toronto Alexithymia Scale
|
screening
|
satisfaction with current and former therapies and influence on decision for online therapy
Time Frame: screening
|
adapted version of ZUF-8 (= "Zufriedenheitsfragebogen mit der Behandlung" english version CSQ- client satisfaction questionnaire) for different experiences with therapy (e.g. for depression, for other psychiatric illnesses)
|
screening
|
sense of coherence
Time Frame: screening
|
influencing outcome?
measured with SOC-13 -Sense of Coherence Scale
|
screening
|
changes in sense of coherence
Time Frame: + 3 months after screening (post) and + 6 months after post
|
measured with SOC-13 does online-therapy helps to develop a better SOC?
|
+ 3 months after screening (post) and + 6 months after post
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changes alexithymia
Time Frame: + 3 months after screening (post) , + 6 months after post
|
Trait and state characteristics of alexithymia in depression measured with TAS-20
|
+ 3 months after screening (post) , + 6 months after post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: S Weidt, MD, USZ, UZH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
April 4, 2014
First Submitted That Met QC Criteria
April 9, 2014
First Posted (Estimate)
April 11, 2014
Study Record Updates
Last Update Posted (Estimate)
May 10, 2016
Last Update Submitted That Met QC Criteria
May 9, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICBT
- 2013-0542 (Other Identifier: KEK Zurich CH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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