Chronic Depressive DisorderNCT02397850
Development of a Telephone-based Continuation Treatment for Patients With Chronic Depression.
A study testing phone calls 30 min and phone calls 50 min in people with Chronic Depressive Disorder, run by University of Zurich at 1 site in Switzerland.
Trial summary
There is a high risk for relapse in people suffering from depression. Studies indicate that the continuation of an acute psychotherapeutic treatment can reduce the likelihood of relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Depressive Disorder
- What is being tested?
- phone calls 30 min and phone calls 50 min
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to 25 Oct 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Diagnosis of chronic (300.4) or recurrent (296.31-3) depression (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- Currently in partial or full remission
- Previous psychotherapy (acute treatment; some kind of cognitive-behavioral therapy)
- adequate knowledge of German language
- in case of taking antidepressants: long-term and stable dosage (with unchanged taking since 3 months at least)
Who cannot join
- acute suicidality
- psychotic symptoms
- severe cognitive impairments
- in case of taking antidepressants: anticipated stopping medication within treatment period (6 months)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
UniversitätsSpital Zürich Klinik für Psychiatrie und Psychotherapie Ambulatorium
Zurich, 8091
About this study
Official title: Optimizing Psychotherapeutic Aftercare for Patients Suffering From Chronic/Recurrent Depression: Development and First Evaluation of a Telephone-based Continuation Treatment (Pilot Study).
There is a high risk for relapse in people suffering from depression. Studies indicate that the continuation of an acute psychotherapeutic treatment can reduce the likelihood of relapse. Therefore, this pilot study is aimed to investigate the feasibility of a continuation psychotherapy over 6 months, to support people suffering from chronic forms of depression in their daily life. The investigated continuation therapy itself includes about one telephone call per month (therapist - patient), focussing on the integration of strategies into the patient's daily routine. The patients receive either 30 minutes or 50 minutes phone calls. On the one hand, these phone calls are supported by a workbook for patients containing psychoeducative elements, strategies and exercises. On the other hand, the therapist's work is based on a manual containing several modules and strategies. Both tools (workbook, manual) are understood as a framework, using the appropriate sections according to the patient's needs. As a result, the patients receive a continuation treatment which is appropriate and adapted to their individual situation.
The main purpose of this pilot study is to evaluate the feasibility of a telephone based psychotherapeutic continuation treatment with a small sample of 20 patients suffering from chronic depression. In case of promising results the effectiveness of this kind of treatment is going to be investigated within a comparative trial (including face-to-face intervention, no intervention).
- Conditions
- Chronic Depressive Disorder
- Being tested
- phone calls 30 min, phone calls 50 min
- Keywords
- depression, chronic, psychotherapy, telephone, feasibility
- Medical subject headings
- Depression, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone calls 30 minBehavioural
Patients receive either seven 30 minutes phone calls over 6 months (psychotherapy/continuation treatment)
phone calls 50 minBehavioural
Patients receive either seven 50 minutes phone calls over 6 months (psychotherapy/continuation treatment)
| Study group | Role | What they receive |
|---|---|---|
| 30 min or 50 min | Experimental | Patients receive either seven 30 minutes or 50 minutes phone calls over 6 months (psychotherapy/continuation treatment) Receives: Behavioral: phone calls 30 min; Behavioral: phone calls 50 min |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients dropping out of treatment
Measured: 6 months
change of depressive symptoms from baseline to posttreatment
assessed by the Patient Health Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion20 May 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgit Watzke, Prof. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397850
- Sponsor's protocol ID
- WATZKE-892
- Status last verified
- Nov 2017
- First submitted
- 14 Jan 2015
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Psychotherapeutic Aftercare for Patients Suffering From Chronic/Recurrent Depression: Development and First Evaluation of a Telephone-based Continuation Treatment (Pilot Study).
- ClinicalTrials.gov ID
- NCT02397850
- Acronym / sponsor ID
- WATZKE-892
- Conditions
- Chronic Depressive Disorder
- Keywords
- depression, chronic, psychotherapy, telephone, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 25 Mar 2015 (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.
There is a high risk for relapse in people suffering from depression. Studies indicate that the continuation of an acute psychotherapeutic treatment can reduce the likelihood of relapse. Therefore, this pilot study is aimed to investigate the feasibility of a continuation psychotherapy over 6 months, to support people suffering from chronic forms of depression in their daily life. The investigated continuation therapy itself includes about one telephone call per month (therapist - patient), focussing on the integration of strategies into the patient's daily routine. The patients receive either 30 minutes or 50 minutes phone calls. On the one hand, these phone calls are supported by a workbook for patients containing psychoeducative elements, strategies and exercises. On the other hand, the therapist's work is based on a manual containing several modules and strategies. Both tools (workbook, manual) are understood as a framework, using the appropriate sections according to the patient's needs. As a result, the patients receive a continuation treatment which is appropriate and adapted to their individual situation.
The main purpose of this pilot study is to evaluate the feasibility of a telephone based psychotherapeutic continuation treatment with a small sample of 20 patients suffering from chronic depression. In case of promising results the effectiveness of this kind of treatment is going to be investigated within a comparative trial (including face-to-face intervention, no intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 min or 50 min | Experimental | Behavioral: phone calls 30 min, Behavioral: phone calls 50 minPatients receive either seven 30 minutes or 50 minutes phone calls over 6 months (psychotherapy/continuation treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- Diagnosis of chronic (300.4) or recurrent (296.31-3) depression (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition)
- Currently in partial or full remission
- Previous psychotherapy (acute treatment; some kind of cognitive-behavioral therapy)
- adequate knowledge of German language
Key exclusion criteria (4 listed)
- acute suicidality
- psychotic symptoms
- severe cognitive impairments
- in case of taking antidepressants: anticipated stopping medication within treatment period (6 months)
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 |
|---|---|---|
| phone calls 30 minPatients receive either seven 30 minutes phone calls over 6 months (psychotherapy/continuation treatment) | Behavioural | 30 min or 50 min |
| phone calls 50 minPatients receive either seven 50 minutes phone calls over 6 months (psychotherapy/continuation treatment) | Behavioural | 30 min or 50 min |
Primary outcome
number of patients dropping out of treatment
Time frame: 6 months
change of depressive symptoms from baseline to posttreatment
Time frame: 6 months
assessed by the Patient Health Questionnaire
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 7 Nov 2017.
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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.
Birgit Watzke, Prof. Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phone calls 30 min and phone calls 50 min in people with Chronic Depressive Disorder, 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 6 inclusion and 4 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 7 Nov 2017. 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?
number of patients dropping out of treatment (time frame: 6 months). The study lists 2 primary outcomes in all. 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 7 Nov 2017; AzTrials last refreshed its copy on 6 Nov 2026.