Back to resultsDepression Online Assessment and Therapy
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mail support
no mail support
Sponsored by
About this trial
This is an interventional screening trial for Depression focused on measuring depression, online therapy, cognitive behavioural therapy, quality of life, alexithymia, therapy expectation and satisfaction
Eligibility Criteria
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
Sites / Locations
- University Hospital Zurich - only online recruitment
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
no mail support
mail support
Arm Description
no mail support during follow-up
Outcomes
Primary Outcome Measures
Change of Quality of life
WHOQol brev - WHO quality of life questionnaire short form
Secondary Outcome Measures
change of Sleep quality
Questionnaire PSQI - Pittsburgh sleep quality index
change of severity of depression
patients receive mail support or not during follow up. Questionnaire: BDI - Beck Depression Inventory
Full Information
NCT ID
NCT02112266
First Posted
April 4, 2014
Last Updated
May 9, 2016
Sponsor
University of Zurich
Collaborators
Makora
1. Study Identification
Unique Protocol Identification Number
NCT02112266
Brief Title
Depression Online Assessment and Therapy
Official Title
Online Assessment for Therapy Expectation and Quality of Life and Online Therapy of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Makora
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, online therapy, cognitive behavioural therapy, quality of life, alexithymia, therapy expectation and satisfaction
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no mail support
Arm Type
Other
Arm Description
no mail support during follow-up
Arm Title
mail support
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Mail support
Intervention Description
between post treatment and follow up two groups: one with unspecific mail support every 2 weeks one without
Intervention Type
Other
Intervention Name(s)
no mail support
Intervention Description
follow-up without mail support
Primary Outcome Measure Information:
Title
Change of Quality of life
Description
WHOQol brev - WHO quality of life questionnaire short form
Time Frame
at screening, post treatment (3 months) and follow-up (6 months after post)
Secondary Outcome Measure Information:
Title
change of Sleep quality
Description
Questionnaire PSQI - Pittsburgh sleep quality index
Time Frame
screening, post treatment (3 months), follow-up(6 months after post)
Title
change of severity of depression
Description
patients receive mail support or not during follow up. Questionnaire: BDI - Beck Depression Inventory
Time Frame
3 time points screening, + 3 months + 6 months
Other Pre-specified Outcome Measures:
Title
change of therapy expectation during online-therapy
Description
therapy expectation at screening and after intervention. Questionnaire: PECHI - Psychotherapy Expectations, Concerns, and Hopes Inventory
Time Frame
3 time points screening + 3 months + 6 months
Title
alexithymia
Description
influences on outcome? Questionnaire: TAS - Toronto Alexithymia Scale
Time Frame
screening
Title
satisfaction with current and former therapies and influence on decision for online therapy
Description
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)
Time Frame
screening
Title
sense of coherence
Description
influencing outcome? measured with SOC-13 -Sense of Coherence Scale
Time Frame
screening
Title
changes in sense of coherence
Description
measured with SOC-13 does online-therapy helps to develop a better SOC?
Time Frame
+ 3 months after screening (post) and + 6 months after post
Title
changes alexithymia
Description
Trait and state characteristics of alexithymia in depression measured with TAS-20
Time Frame
+ 3 months after screening (post) , + 6 months after post
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Weidt, MD
Organizational Affiliation
USZ, UZH
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich - only online recruitment
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Links:
URL
http://ww2.unipark.de/uc/depression_prae/
Description
screening link for participants
Learn more about this trial
Depression Online Assessment and Therapy
We'll reach out to this number within 24 hrs