Telephone-administered Relapse Prevention for Depression
- Conditions
- Depressive Disorder
- Interventions
- Behavioral: Telephone-administered continuation therapyOther: Usual care
- Registration Number
- NCT03219879
- Lead Sponsor
- University of Zurich
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telephone-administered continuation therapy Telephone-administered continuation therapy Cognitive-behavioral continuation therapy (T-CT) delivered over the telephone by trained psychotherapist Usual care Usual care Treatment as usual
- Primary Outcome Measures
Name Time Method Relapse of a major depressive episode 6 months, 12 months, and 18 months after baseline 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
- Secondary Outcome Measures
Name Time Method Health-related quality of life Baseline, 3 months, 6 months, and 12 months after baseline 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
Depressive symptoms Baseline, 3 months, 6 months, and 12 months after baseline Self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3-, 6-, and 12-month follow-up
Anxiety symptoms Baseline, 3 months, 6 months, and 12 months after baseline Self-reported anxiety symptoms assessed with the General Anxiety Disorder 7 (GAD-7) screener at baseline, 3-, 6-, and 12-month follow-up
Psychosocial functioning 6 months and 12 months after baseline 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
Cost-effectiveness Baseline, 6 months, and 12 months after baseline 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
Well-weeks 6 months, 12 months, and 18 months after baseline 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
Cost of health care utilization Baseline, 6 months, and 12 months after baseline 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
Trial Locations
- Locations (11)
Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG
🇨🇭Gais, Switzerland
Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR
🇨🇭Herisau, Switzerland
Praxisstelle Psychotherapie, Universität Zürich
🇨🇭Zürich, Switzerland
Klinik SGM Langenthal
🇨🇭Langenthal, Switzerland
Klinik für Psychiatrie und Psychotherapie, UniversitätsSpital Zürich
🇨🇭Zürich, Switzerland
Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG
🇨🇭Brugg, Switzerland
Zentrum für seelische Gesundheit, Privatklinik Meiringen
🇨🇭Meiringen, Switzerland
Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern
🇨🇭Bern, Switzerland
Zentrum für Psychiatrie und Psychotherapie Klinik Zugersee, Triaplus AG
🇨🇭Oberwil, Switzerland
Psychiatrische und Psychotherapeutische Spezialklinik für Frauen, Klinik Meissenberg AG
🇨🇭Zug, Switzerland
Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart
🇩🇪Stuttgart, Germany