Depressive DisorderNaTelNCT03219879
Telephone-administered Relapse Prevention for Depression
A study testing Telephone-administered continuation therapy in people with Depressive Disorder, run by University of Zurich at 11 sites in 2 countries.
Trial summary
This study determines the effectiveness of telephone-delivered cognitive-behavioral continuation therapy (T-CT) in comparison to usual care in people with recurrent or chronic depression. The primary research question is whether participating in T-CT reduces depressive relapses. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Telephone-administered continuation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 29 Sep 2017to 8 Apr 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent major depressive disorder or chronic/persistent depressive disorder based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), or first major depressive episode with an elevated risk for relapse (defined as the presence of at least of the following clinical characteristics: index episode duration ≥ six months; severity of the index episode at least moderate; DSM-5 comorbidity; residual symptoms at the end of index treatment)
- Having regularly terminated acute-phase CBT for depression (index treatment)
- Having achieved therapeutic response during index therapy defined as at least 25%-improvement in depressive symptoms between start and end of acute-phase therapy based on a standardized symptom measure (e.g. PHQ-9, or Beck Depression Inventory; BDI)
- Having experienced partial or full remission at the end of the index treatment based on DSM-5 criteria for major depressive disorder
- Sufficient command of German language
- Having given written informed consent
Who cannot join
- Unstable psychopharmacological medication regimen (either with or without antidepressant (AD) medication) at the end of the index treatment, i.e. change in type or dosage of medication envisaged at the end of index treatment
- Acute risk for suicide based on clinical practice guidelines; patients with self-reported suicidal ideation are eligible as long as the treatment is deemed safe by the clinician's judgment
- A history of or acute psychotic symptoms, bipolar disorder, or organic brain disorder
- Severe cognitive impairment based on clinical evaluation during index treatment
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Switzerland10 sites
Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern
Bern
Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG
Brugg
Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG
Gais
Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR
Herisau
Klinik SGM Langenthal
Langenthal, 4900
Zentrum für seelische Gesundheit, Privatklinik Meiringen
Meiringen, 3860
Zentrum für Psychiatrie und Psychotherapie Klinik Zugersee, Triaplus AG
Oberwil
Psychiatrische und Psychotherapeutische Spezialklinik für Frauen, Klinik Meissenberg AG
Zug
Klinik für Psychiatrie und Psychotherapie, UniversitätsSpital Zürich
Zurich
Praxisstelle Psychotherapie, Universität Zürich
Zurich
Germany1 site
Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart
Stuttgart
About this study
Official title: Telephone-administered Cognitive-behavioral Relapse Prevention for Patients with Chronic and Recurrent Depression: a Multi-center Randomized Clinical Trial
This study determines the effectiveness of telephone-delivered cognitive-behavioral continuation therapy (T-CT) in comparison to usual care in people with recurrent or chronic depression. The primary research question is whether participating in T-CT reduces depressive relapses. The continuation therapy comprises eight therapy sessions delivered over the telephone by a trained therapist over a period of approximately six months following acute-phase psychotherapy.
Read the detailed description
Major depression is a serious mental disorder that often takes a recurrent or chronic course causing enduring individual suffering as well as immense direct and indirect health costs. Research indicates that psychological continuation interventions following successful acute-phase therapy are effective in preventing depressive relapse and recurrence but access to these interventions is limited. Systematic psychological continuation interventions are hardly implemented in health care yet, and research shows that there are obstacles concerning access to and compliance for these interventions in a face-to-face setting underlining the need for alternative ways of delivery. The present study ("NaTel study") aims to investigate the effectiveness of telephone-administered cognitive-behavioral continuation therapy (T-CT) following acute-phase psychotherapy. The primary research question is whether participating in T-CT reduces depressive relapses within an observation period of 18 months compared with usual care alone. T-CT comprises eight therapy sessions delivered over the telephone by a trained therapist over a period of approximately six months after acute-phase therapy. Focus of the structured intervention is to train and foster relapse prevention strategies and to facilitate the transfer of skills acquired during acute-phase therapy to daily life. The effectiveness of T-CT as add-on to usual care is tested in a two-parallel group, multicenter, evaluator-blind clinical trial in patients with chronic/persistent or recurrent depressive disorder. Upon acute-phase therapy termination patients who have responded to cognitive behavioral therapy are randomized either to T-CT or usual care alone. Primary outcome of this study is relapse of a depressive episode. Relapse is determined by investigators blind to the study conditions based on clinical interviews conducted at months 6, 12, and 18 of follow-up. Further secondary outcome criteria are assessed with interviews and self-report questionnaires at various time points during follow-up. Overall, the study lasts approximately 48 months.
- Conditions
- Depressive Disorder
- Being tested
- Telephone-administered continuation therapy, Usual care
- Keywords
- Relapse prevention, Persistent depressive disorder, Recurrent depressive disorder, Telephone-based intervention, Cognitive behavioral therapy
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-administered continuation therapyBehavioural
The intervention includes eight therapy sessions of approx. 50 minutes duration delivered over the telephone by trained psychotherapists over a time period of six months. The intervention is grounded in the principles of psychological continuation therapy and relapse prevention, and includes strategies such as transferring helpful elements of acute-phase cognitive-behavioral therapy (CBT) for depression to daily life. T-CT is offered in addition to usual care.
Usual careOther
Also called Treatment as usual (TAU)
Usual care without any study-related intervention
| Study group | Role | What they receive |
|---|---|---|
| Telephone-administered continuation therapy | Experimental | Cognitive-behavioral continuation therapy (T-CT) delivered over the telephone by trained psychotherapist Receives: Behavioral: Telephone-administered continuation therapy |
| Usual care | Active comparator | Treatment as usual Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse of a major depressive episode
Relapse is assessed with the Longitudinal Interval Follow-up Evaluation (LIFE) and defined as a Psychiatric Status Rating (PSR) of PSR=5 or PSR=6 on the 6-point PSR scale for affective disorders for at least two consecutive weeks during a total of 18 months follow-up according to evaluators who are blinded to group allocation
Measured: 6 months, 12 months, and 18 months after baseline
Secondary outcomes (7)
Well-weeks
Number of weeks without depressive symptoms defined as weeks with a PSR=1 or PSR=2 on the PSR 6-point scale for affective disorders assessed with the LIFE at month 6, 12 and 18 of follow-up according to blind evaluators
Measured: 6 months, 12 months, and 18 months after baseline
Depressive symptoms
Self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3-, 6-, and 12-month follow-up
Measured: Baseline, 3 months, 6 months, and 12 months after baseline
Health-related quality of life
Health-related quality of life (HrQoL) based on patient self-report assessed with the 12-Item Short Form Health Survey (SF-12) at baseline, 3-, 6- and12-month follow-up
Measured: Baseline, 3 months, 6 months, and 12 months after baseline
Anxiety symptoms
Self-reported anxiety symptoms assessed with the General Anxiety Disorder 7 (GAD-7) screener at baseline, 3-, 6-, and 12-month follow-up
Measured: Baseline, 3 months, 6 months, and 12 months after baseline
Psychosocial functioning
Psychosocial functioning assessed with the LIFE-Range of Impaired Functioning Tool (LIFE-RIFT) and Global Assessment of Functioning (GAF) based on monthly ratings by blind evaluators
Measured: 6 months and 12 months after baseline
Cost of health care utilization
Direct and indirect cost derived from health care utilization and productivity loss are assessed with the Client Sociodemographic and Service Receipt Inventory (CSSRI-D) at baseline, 6- and 12-month follow-up
Measured: Baseline, 6 months, and 12 months after baseline
Cost-effectiveness
Health-related quality of life assessments for health economic analyses by the determination of Quality-Adjusted Life Years (QALYs) are based on the EuroQol-five dimension questionnaire five-level version (EQ-5D-5L) administered at baseline, 6- and 12-month follow-up
Measured: Baseline, 6 months, and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start29 Sep 2017
- Primary completion8 Apr 2023
- Study completion8 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Birgit Watzke, Prof, Principal investigator, University of ZurichMarkus Wolf, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219879
- Sponsor's protocol ID
- 100019_166009 / 1
- Acronym
- NaTel
- Status last verified
- Feb 2025
- First submitted
- 20 Jun 2017
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-administered Cognitive-behavioral Relapse Prevention for Patients with Chronic and Recurrent Depression: a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03219879
- Acronym / sponsor ID
- NaTel / 100019_166009 / 1
- Conditions
- Depressive Disorder
- Keywords
- Relapse prevention, Persistent depressive disorder, Recurrent depressive disorder, Telephone-based intervention, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, University Hospital, Zürich
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 8 Apr 2023 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 18 Jul 2017 (actual)
- 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.
This study determines the effectiveness of telephone-delivered cognitive-behavioral continuation therapy (T-CT) in comparison to usual care in people with recurrent or chronic depression. The primary research question is whether participating in T-CT reduces depressive relapses. The continuation therapy comprises eight therapy sessions delivered over the telephone by a trained therapist over a period of approximately six months following acute-phase psychotherapy.
Detailed description
Major depression is a serious mental disorder that often takes a recurrent or chronic course causing enduring individual suffering as well as immense direct and indirect health costs. Research indicates that psychological continuation interventions following successful acute-phase therapy are effective in preventing depressive relapse and recurrence but access to these interventions is limited. Systematic psychological continuation interventions are hardly implemented in health care yet, and research shows that there are obstacles concerning access to and compliance for these interventions in a face-to-face setting underlining the need for alternative ways of delivery. The present study ("NaTel study") aims to investigate the effectiveness of telephone-administered cognitive-behavioral continuation therapy (T-CT) following acute-phase psychotherapy. The primary research question is whether participating in T-CT reduces depressive relapses within an observation period of 18 months compared with usual care alone. T-CT comprises eight therapy sessions delivered over the telephone by a trained therapist over a period of approximately six months after acute-phase therapy. Focus of the structured intervention is to train and foster relapse prevention strategies and to facilitate the transfer of skills acquired during acute-phase therapy to daily life. The effectiveness of T-CT as add-on to usual care is tested in a two-parallel group, multicenter, evaluator-blind clinical trial in patients with chronic/persistent or recurrent depressive disorder. Upon acute-phase therapy termination patients who have responded to cognitive behavioral therapy are randomized either to T-CT or usual care alone. Primary outcome of this study is relapse of a depressive episode. Relapse is determined by investigators blind to the study conditions based on clinical interviews conducted at months 6, 12, and 18 of follow-up. Further secondary outcome criteria are assessed with interviews and self-report questionnaires at various time points during follow-up. Overall, the study lasts approximately 48 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone-administered continuation therapy | Experimental | Behavioral: Telephone-administered continuation therapyCognitive-behavioral continuation therapy (T-CT) delivered over the telephone by trained psychotherapist |
| Usual care | Active comparator | Other: Usual careTreatment as usual |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recurrent major depressive disorder or chronic/persistent depressive disorder based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), or first major depressive episode with an elevated risk for relapse (defined as the presence of at least of the following clinical characteristics: index episode duration ≥ six months; severity of the index episode at least moderate; DSM-5 comorbidity; residual symptoms at the end of index treatment)
- Having regularly terminated acute-phase CBT for depression (index treatment)
- Having achieved therapeutic response during index therapy defined as at least 25%-improvement in depressive symptoms between start and end of acute-phase therapy based on a standardized symptom measure (e.g. PHQ-9, or Beck Depression Inventory; BDI)
- Having experienced partial or full remission at the end of the index treatment based on DSM-5 criteria for major depressive disorder
- Sufficient command of German language
Key exclusion criteria (4 listed)
- Unstable psychopharmacological medication regimen (either with or without antidepressant (AD) medication) at the end of the index treatment, i.e. change in type or dosage of medication envisaged at the end of index treatment
- Acute risk for suicide based on clinical practice guidelines; patients with self-reported suicidal ideation are eligible as long as the treatment is deemed safe by the clinician's judgment
- A history of or acute psychotic symptoms, bipolar disorder, or organic brain disorder
- Severe cognitive impairment based on clinical evaluation during index treatment
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 |
|---|---|---|
| Telephone-administered continuation therapyThe intervention includes eight therapy sessions of approx. 50 minutes duration delivered over the telephone by trained psychotherapists over a time period of six months. The intervention is grounded in the principles of psychological continuation therapy and relapse prevention, and includes strategies such as transferring helpful elements of acute-phase cognitive-behavioral therapy (CBT) for depression to daily life. T-CT is offered in addition to usual care. | Behavioural | Telephone-administered continuation therapy |
| Usual careAlso: Treatment as usual (TAU)Usual care without any study-related intervention | Other | Usual care |
Primary outcome
Relapse of a major depressive episode
Time frame: 6 months, 12 months, and 18 months after baseline
Relapse is assessed with the Longitudinal Interval Follow-up Evaluation (LIFE) and defined as a Psychiatric Status Rating (PSR) of PSR=5 or PSR=6 on the 6-point PSR scale for affective disorders for at least two consecutive weeks during a total of 18 months follow-up according to evaluators who are blinded to group allocation
7 secondary outcomes
Well-weeks
Time frame: 6 months, 12 months, and 18 months after baseline
Depressive symptoms
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
Health-related quality of life
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
Anxiety symptoms
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
Psychosocial functioning
Time frame: 6 months and 12 months after baseline
Cost of health care utilization
Time frame: Baseline, 6 months, and 12 months after baseline
Cost-effectiveness
Time frame: Baseline, 6 months, and 12 months after baseline
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 17 Feb 2025.
- Brief abstract of the trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 principal investigator
University of Zurich
Markus Wolf, PhD principal investigator
University of Zurich
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-administered continuation therapy in people with Depressive Disorder, run by University of Zurich at 11 sites in 2 countries.
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 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Switzerland, Germany. 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?
Relapse of a major depressive episode (time frame: 6 months, 12 months, and 18 months after baseline). 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 17 Feb 2025.