Telephone-administered Relapse Prevention for Depression

NCT ID: NCT03219879

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2023-04-08

Brief 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. 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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telephone-administered continuation therapy

Cognitive-behavioral continuation therapy (T-CT) delivered over the telephone by trained psychotherapist

Group Type: EXPERIMENTAL

Telephone-administered continuation therapy

Intervention Type: BEHAVIORAL

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 care

Treatment as usual

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Usual care without any study-related intervention

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care

Usual care without any study-related intervention

Intervention Type: OTHER

Other Intervention Names

Treatment as usual (TAU)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birgit Watzke, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Markus Wolf, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart

Stuttgart, , Germany

Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern

Bern, , Switzerland

Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG

Brugg, , Switzerland

Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG

Gais, , Switzerland

Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR

Herisau, , Switzerland

Klinik SGM Langenthal

Langenthal, , Switzerland

Zentrum für seelische Gesundheit, Privatklinik Meiringen

Meiringen, , Switzerland

Zentrum für Psychiatrie und Psychotherapie Klinik Zugersee, Triaplus AG

Oberwil, , Switzerland

Psychiatrische und Psychotherapeutische Spezialklinik für Frauen, Klinik Meissenberg AG

Zug, , Switzerland

Klinik für Psychiatrie und Psychotherapie, UniversitätsSpital Zürich

Zurich, , Switzerland

Praxisstelle Psychotherapie, Universität Zürich

Zurich, , Switzerland

Countries

Germany; Switzerland

Related Links

http://www.psychologie.uzh.ch/de/fachrichtungen/klipfor/forschung/forschungsprojekte.html

Brief abstract of the trial

Other Identifiers

100019_166009 / 1

Identifier Type: -

Identifier Source: org_study_id