Depression Online Assessment and Therapy

Depression Clinical Trial

Official title:

Online Assessment for Therapy Expectation and Quality of Life and Online Therapy of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112266
• Other study ID #: ICBT
• Secondary ID: 2013-0542
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: May 9, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Mail support
between post treatment and follow up two groups: one with unspecific mail support every 2 weeks one without
• no mail support
follow-up without mail support

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich - only online recruitment	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Makora

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change of therapy expectation during online-therapy	therapy expectation at screening and after intervention. Questionnaire: PECHI - Psychotherapy Expectations, Concerns, and Hopes Inventory	3 time points screening + 3 months + 6 months	No
Other	alexithymia	influences on outcome? Questionnaire: TAS - Toronto Alexithymia Scale	screening	No
Other	satisfaction with current and former therapies and influence on decision for online therapy	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	No
Other	sense of coherence	influencing outcome? measured with SOC-13 -Sense of Coherence Scale	screening	No
Other	changes in sense of coherence	measured with SOC-13 does online-therapy helps to develop a better SOC?	+ 3 months after screening (post) and + 6 months after post	No
Other	changes alexithymia	Trait and state characteristics of alexithymia in depression measured with TAS-20	+ 3 months after screening (post) , + 6 months after post	No
Primary	Change of Quality of life	WHOQol brev - WHO quality of life questionnaire short form	at screening, post treatment (3 months) and follow-up (6 months after post)	No
Secondary	change of Sleep quality	Questionnaire PSQI - Pittsburgh sleep quality index	screening, post treatment (3 months), follow-up(6 months after post)	No
Secondary	change of severity of depression	patients receive mail support or not during follow up. Questionnaire: BDI - Beck Depression Inventory	3 time points screening, + 3 months + 6 months	No

External Links

•   screening link for participants