- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03219879
Telephone-administered Relapse Prevention for Depression (NaTel)
July 17, 2023 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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
201
Phase
- 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
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Stuttgart, Germany
- Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart
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Bern, Switzerland
- Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern
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Brugg, Switzerland
- Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG
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Gais, Switzerland
- Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG
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Herisau, Switzerland
- Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR
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Langenthal, Switzerland, 4900
- Klinik SGM Langenthal
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Meiringen, Switzerland, 3860
- Zentrum für seelische Gesundheit, Privatklinik Meiringen
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Oberwil, Switzerland
- Zentrum für Psychiatrie und Psychotherapie Klinik Zugersee, Triaplus AG
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Zug, Switzerland
- Psychiatrische und Psychotherapeutische Spezialklinik für Frauen, Klinik Meissenberg AG
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Zürich, Switzerland
- Klinik für Psychiatrie und Psychotherapie, UniversitätsSpital Zürich
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Zürich, Switzerland
- Praxisstelle Psychotherapie, Universität Zürich
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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
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 |
Intervention / Treatment |
---|---|
Experimental: Telephone-administered continuation therapy
Cognitive-behavioral continuation therapy (T-CT) delivered over the telephone by trained psychotherapist
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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.
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Active Comparator: Usual care
Treatment as usual
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Usual care without any study-related intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse of a major depressive episode
Time Frame: 6 months, 12 months, and 18 months after baseline
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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
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6 months, 12 months, and 18 months after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Well-weeks
Time Frame: 6 months, 12 months, and 18 months after baseline
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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
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6 months, 12 months, and 18 months after baseline
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Depressive symptoms
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
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Self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3-, 6-, and 12-month follow-up
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Baseline, 3 months, 6 months, and 12 months after baseline
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Health-related quality of life
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
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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
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Baseline, 3 months, 6 months, and 12 months after baseline
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Anxiety symptoms
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
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Self-reported anxiety symptoms assessed with the General Anxiety Disorder 7 (GAD-7) screener at baseline, 3-, 6-, and 12-month follow-up
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Baseline, 3 months, 6 months, and 12 months after baseline
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Psychosocial functioning
Time Frame: 6 months and 12 months after baseline
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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
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6 months and 12 months after baseline
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Cost of health care utilization
Time Frame: Baseline, 6 months, and 12 months after baseline
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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
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Baseline, 6 months, and 12 months after baseline
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Cost-effectiveness
Time Frame: Baseline, 6 months, and 12 months after baseline
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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
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Baseline, 6 months, and 12 months after baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T-CT acceptability
Time Frame: 6 months after baseline
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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
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6 months after baseline
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Treatment satisfaction
Time Frame: Baseline, and 6 months after baseline
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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)
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Baseline, and 6 months after baseline
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Self-confidence
Time Frame: Baseline, 6 months, and 12 months after baseline
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Participants' self-reported general levels of confidence assessed at baseline, 6- and 12-month follow-up
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Baseline, 6 months, and 12 months after baseline
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Physical activity
Time Frame: Baseline, 6 months, and 12 months after baseline
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Participants' levels of physical activity assessed with the International Physical Activity Questionnaire Short Form (IPAC-SF) at baseline, 6- and 12-month follow-up
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Baseline, 6 months, and 12 months after baseline
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Self-efficacy for depression self-management
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
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Self-efficacy for depression self-management assessed via self-report questionnaire at baseline, 3-, 6- and 12-month follow-up
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Baseline, 3 months, 6 months, and 12 months after baseline
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Self-management behaviors
Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline
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Depression-related self-management behaviors assessed via self-report questionnaire at baseline, 3-, 6-, and 12-month follow-up
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Baseline, 3 months, 6 months, and 12 months after baseline
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Interpersonal emotion regulation skills
Time Frame: Baseline, 6 months, and 12 months after baseline
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Participants' interpersonal emotion regulation skills assessed with the Interpersonal Emotion Regulation Questionnaire (IERQ) at baseline, 6- and 12-month follow-up
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Baseline, 6 months, and 12 months after baseline
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Therapeutic alliance
Time Frame: Baseline, 3 months, and 6 months after baseline
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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)
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Baseline, 3 months, and 6 months after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
September 29, 2017
Primary Completion (Actual)
April 8, 2023
Study Completion (Actual)
April 8, 2023
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
July 13, 2017
First Posted (Actual)
July 18, 2017
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100019_166009 / 1
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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