DepressionNCT02112266
Depression Online Assessment and Therapy
A study testing Mail support and no mail support in people with Depression, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Mail support and no mail support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- German language
- depression at least slight according BDI (Beck depression inventory) and at least 2 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich - only online recruitment
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
Read the 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
- Conditions
- Depression
- Being tested
- Mail support, no mail support
- Keywords
- depression, online therapy, cognitive behavioural therapy, quality of life, alexithymia, therapy expectation and satisfaction
- Medical subject headings
- Depression, Affective Symptoms, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mail supportOther
between post treatment and follow up two groups: one with unspecific mail support every 2 weeks one without
no mail supportOther
follow-up without mail support
| Study group | Role | What they receive |
|---|---|---|
| no mail support | Other | no mail support during follow-up Receives: Other: no mail support |
| mail support | Other | Not described Receives: Other: Mail support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Quality of life
WHOQol brev - WHO quality of life questionnaire short form
Measured: at screening, post treatment (3 months) and follow-up (6 months after post)
Secondary outcomes (2)
change of Sleep quality
Questionnaire PSQI - Pittsburgh sleep quality index
Measured: screening, post treatment (3 months), follow-up(6 months after post)
change of severity of depression
patients receive mail support or not during follow up. Questionnaire: BDI - Beck Depression Inventory
Measured: 3 time points screening, + 3 months + 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Makora
- Responsible party
- Sponsor
- Investigators
- S Weidt, MD, Principal investigator, USZ, UZH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112266
- Sponsor's protocol ID
- ICBT
- Other IDs
- 2013-0542
- Status last verified
- May 2016
- First submitted
- 4 Apr 2014
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Assessment for Therapy Expectation and Quality of Life and Online Therapy of Depression
- ClinicalTrials.gov ID
- NCT02112266
- Acronym / sponsor ID
- ICBT
- Conditions
- Depression
- Keywords
- depression, online therapy, cognitive behavioural therapy, quality of life, alexithymia, therapy expectation and satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Makora
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no mail support | Other | Other: no mail supportno mail support during follow-up |
| mail support | Other | Other: Mail support |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- German language
- depression at least slight according BDI (Beck depression inventory) and at least 2 weeks
Key exclusion criteria (6 listed)
- severe depression according BDI
- suicidal ideation
- alcohol or drug dependency
- history of psychotic symptoms
- history of bipolar disorder or previous mania
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mail supportbetween post treatment and follow up two groups: one with unspecific mail support every 2 weeks one without | Other | mail support |
| no mail supportfollow-up without mail support | Other | no mail support |
Primary outcome
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
2 secondary outcomes
change of Sleep quality
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S Weidt, MD principal investigator
USZ, UZH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mail support and no mail support in people with Depression, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Quality of life (time frame: at screening, post treatment (3 months) and follow-up (6 months after post)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2016.