Telephone-administered Relapse Prevention for Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT03219879
• Date of registration: 20/06/2017
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Telephone-administered Relapse Prevention for Depression NaTel
• Scientific title: Telephone-administered Cognitive-behavioral Relapse Prevention for Patients With Chronic and Recurrent Depression: A Multi-center Randomized Clinical Trial
• Date of first enrolment: September 29, 2017
• Target sample size: 201
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03219879
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Markus Wolf, PhD
• Affiliation: University of Zurich

• Name: Birgit Watzke, Prof
• Affiliation: University of Zurich

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depressive Disorder

Intervention(s)

Other: Usual care

Behavioral: Telephone-administered continuation therapy

Primary Outcome(s)

Relapse of a major depressive episode [Time Frame: 6 months, 12 months, and 18 months after baseline]

Secondary Outcome(s)

Psychosocial functioning [Time Frame: 6 months and 12 months after baseline]

Anxiety symptoms [Time Frame: Baseline, 3 months, 6 months, and 12 months after baseline]

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]

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]

Secondary ID(s)

100019_166009 / 1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital, Zürich

Universitätsklinikum Hamburg-Eppendorf