Telephone-administered Relapse Prevention for Depression (NaTel)

February 13, 2025 updated by: University of Zurich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Stuttgart, Germany
        • Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart
  • Switzerland
      • Bern, Switzerland
        • Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern
      • Brugg, Switzerland
        • Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG
      • Gais, Switzerland
        • Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG
      • Herisau, Switzerland
        • Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR
      • Langenthal, Switzerland, 4900
        • Klinik SGM Langenthal
      • Meiringen, Switzerland, 3860
        • Zentrum für seelische Gesundheit, Privatklinik Meiringen
      • Oberwil, Switzerland
        • Zentrum für Psychiatrie und Psychotherapie Klinik Zugersee, Triaplus AG
      • Zug, Switzerland
        • Psychiatrische und Psychotherapeutische Spezialklinik für Frauen, Klinik Meissenberg AG
      • Zürich, Switzerland
        • Klinik für Psychiatrie und Psychotherapie, UniversitätsSpital Zürich
      • Zürich, Switzerland
        • Praxisstelle Psychotherapie, Universität Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telephone-administered continuation therapy
Cognitive-behavioral continuation therapy (T-CT) delivered over the telephone by trained psychotherapist
Behavioral: Telephone-administered continuation therapy
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.
Active Comparator: Usual care
Treatment as usual
Other: Usual care
Usual care without any study-related intervention
Other Names:
  • Treatment as usual (TAU)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months, 12 months, and 18 months after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Well-weeks
Time Frame: 6 months, 12 months, and 18 months after baseline
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
6 months, 12 months, and 18 months after baseline
Depressive symptoms
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
Self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3-, 6-, and 12-month follow-up
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
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
Baseline, 3 months, 6 months, and 12 months after baseline
Anxiety symptoms
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
Self-reported anxiety symptoms assessed with the General Anxiety Disorder 7 (GAD-7) screener at baseline, 3-, 6-, and 12-month follow-up
Baseline, 3 months, 6 months, and 12 months after baseline
Psychosocial functioning
Time Frame: 6 months and 12 months after baseline
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
6 months and 12 months after baseline
Cost of health care utilization
Time Frame: Baseline, 6 months, and 12 months after baseline
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
Baseline, 6 months, and 12 months after baseline
Cost-effectiveness
Time Frame: Baseline, 6 months, and 12 months after baseline
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
Baseline, 6 months, and 12 months after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
T-CT acceptability
Time Frame: 6 months after baseline
Satisfaction with and acceptability of the telephone-intervention from therapist and participant perspective at 6-month follow-up (T-CT group only) assessed with a customized self-report evaluation questionnaire
6 months after baseline
Treatment satisfaction
Time Frame: Baseline, and 6 months after baseline
General treatment satisfaction from participant perspective assessed with Client Satisfaction Questionnaire (ZUF-8) at baseline (both groups) and 6-month follow-up (T-CT group only)
Baseline, and 6 months after baseline
Self-confidence
Time Frame: Baseline, 6 months, and 12 months after baseline
Participants' self-reported general levels of confidence assessed at baseline, 6- and 12-month follow-up
Baseline, 6 months, and 12 months after baseline
Physical activity
Time Frame: Baseline, 6 months, and 12 months after baseline
Participants' levels of physical activity assessed with the International Physical Activity Questionnaire Short Form (IPAC-SF) at baseline, 6- and 12-month follow-up
Baseline, 6 months, and 12 months after baseline
Self-efficacy for depression self-management
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
Self-efficacy for depression self-management assessed via self-report questionnaire at baseline, 3-, 6- and 12-month follow-up
Baseline, 3 months, 6 months, and 12 months after baseline
Self-management behaviors
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
Depression-related self-management behaviors assessed via self-report questionnaire at baseline, 3-, 6-, and 12-month follow-up
Baseline, 3 months, 6 months, and 12 months after baseline
Interpersonal emotion regulation skills
Time Frame: Baseline, 6 months, and 12 months after baseline
Participants' interpersonal emotion regulation skills assessed with the Interpersonal Emotion Regulation Questionnaire (IERQ) at baseline, 6- and 12-month follow-up
Baseline, 6 months, and 12 months after baseline
Therapeutic alliance
Time Frame: Baseline, 3 months, and 6 months after baseline
Therapeutic alliance assessed with the Working Alliance Questionnaire-short revised (WAI-SR) from therapist and participant perspective assessed at baseline (both groups), as well as 3- and 6-month follow-up (T-CT group only)
Baseline, 3 months, and 6 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Zürich
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Birgit Watzke, Prof, University of Zurich
  • Principal Investigator: Markus Wolf, PhD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 100019_166009 / 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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