NCT03219879

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2023

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

5.5 years

First QC Date

June 20, 2017

Last Update Submit

February 13, 2025

Conditions

Depressive Disorder

Keywords

Relapse preventionPersistent depressive disorderRecurrent depressive disorderTelephone-based interventionCognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months, 12 months, and 18 months after baseline

Secondary Outcomes (7)

  • Well-weeks

    6 months, 12 months, and 18 months after baseline

  • Depressive symptoms

    Baseline, 3 months, 6 months, and 12 months after baseline

  • Health-related quality of life

    Baseline, 3 months, 6 months, and 12 months after baseline

  • Anxiety symptoms

    Baseline, 3 months, 6 months, and 12 months after baseline

  • Psychosocial functioning

    6 months and 12 months after baseline

  • +2 more secondary outcomes

Other Outcomes (8)

  • T-CT acceptability

    6 months after baseline

  • Treatment satisfaction

    Baseline, and 6 months after baseline

  • Self-confidence

    Baseline, 6 months, and 12 months after baseline

  • +5 more other outcomes

Study Arms (2)

Telephone-administered continuation therapy

EXPERIMENTAL

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

Behavioral: Telephone-administered continuation therapy

Usual care

ACTIVE COMPARATOR

Treatment as usual

Other: Usual care

Interventions

Telephone-administered continuation therapyBEHAVIORAL

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.

Telephone-administered continuation therapy
Usual careOTHER

Usual care without any study-related intervention

Also known as: Treatment as usual (TAU)
Usual care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart

Stuttgart, Germany

Location

Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern

Bern, Switzerland

Location

Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG

Brugg, Switzerland

Location

Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG

Gais, Switzerland

Location

Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR

Herisau, Switzerland

Location

Klinik SGM Langenthal

Langenthal, 4900, Switzerland

Location

Zentrum für seelische Gesundheit, Privatklinik Meiringen

Meiringen, 3860, Switzerland

Location

Zentrum für Psychiatrie und Psychotherapie Klinik Zugersee, Triaplus AG

Oberwil, Switzerland

Location

Psychiatrische und Psychotherapeutische Spezialklinik für Frauen, Klinik Meissenberg AG

Zug, Switzerland

Location

Klinik für Psychiatrie und Psychotherapie, UniversitätsSpital Zürich

Zurich, Switzerland

Location

Praxisstelle Psychotherapie, Universität Zürich

Zurich, Switzerland

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Birgit Watzke, Prof

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Markus Wolf, PhD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

July 18, 2017

Study Start

September 29, 2017

Primary Completion

April 8, 2023

Study Completion

April 8, 2023

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(10)DE(1)