Clinical trial NCT03219879: Telephone-administered Relapse Prevention for Depression
Official title: Telephone-administered Cognitive-behavioral Relapse Prevention for Patients with Chronic and Recurrent Depression: a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Keywords: Relapse prevention
Persistent depressive disorder
Recurrent depressive disorder
Telephone-based intervention
Cognitive behavioral therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital, Zürich
First posted: 2017-07-18
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relapse of a major depressive episode
timeFrame: 6 months, 12 months, and 18 months after baseline
Secondary outcomes:
measure: Well-weeks
timeFrame: 6 months, 12 months, and 18 months after baseline
measure: Depressive symptoms
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
measure: Health-related quality of life
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
measure: Anxiety symptoms
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
measure: Psychosocial functioning
timeFrame: 6 months and 12 months after baseline
measure: Cost of health care utilization
timeFrame: Baseline, 6 months, and 12 months after baseline
measure: Cost-effectiveness
timeFrame: Baseline, 6 months, and 12 months after baseline
Other outcomes:
measure: T-CT acceptability
timeFrame: 6 months after baseline
measure: Treatment satisfaction
timeFrame: Baseline, and 6 months after baseline
measure: Self-confidence
timeFrame: Baseline, 6 months, and 12 months after baseline
measure: Physical activity
timeFrame: Baseline, 6 months, and 12 months after baseline
measure: Self-efficacy for depression self-management
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
measure: Self-management behaviors
timeFrame: Baseline, 3 months, 6 months, and 12 months after baseline
measure: Interpersonal emotion regulation skills
timeFrame: Baseline, 6 months, and 12 months after baseline
measure: Therapeutic alliance
timeFrame: Baseline, 3 months, and 6 months after baseline
Locations:
city: Stuttgart
country: Germany
facility: Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart
city: Bern
country: Switzerland
facility: Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern
city: Brugg
country: Switzerland
facility: Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG
city: Gais
country: Switzerland
facility: Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG
city: Herisau
country: Switzerland
facility: Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR
city: Langenthal
country: Switzerland
facility: Klinik SGM Langenthal
city: Meiringen
country: Switzerland
facility: Zentrum für seelische Gesundheit, Privatklinik Meiringen
city: Oberwil
country: Switzerland
facility: Zentrum für Psychiatrie und Psychotherapie Klinik Zugersee, Triaplus AG
city: Zug
country: Switzerland
facility: Psychiatrische und Psychotherapeutische Spezialklinik für Frauen, Klinik Meissenberg AG
city: Zürich
country: Switzerland
facility: Klinik für Psychiatrie und Psychotherapie, UniversitätsSpital Zürich
city: Zürich
country: Switzerland
facility: Praxisstelle Psychotherapie, Universität Zürich
Study officials:
affiliation: University of Zurich
name: Birgit Watzke, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Markus Wolf, PhD
role: PRINCIPAL_INVESTIGATOR
References: