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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
201
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 without any study-related intervention
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
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
Time frame: 6 months, 12 months, and 18 months after baseline
Well-weeks
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
Time frame: 6 months, 12 months, and 18 months after baseline
Depressive symptoms
Self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3-, 6-, and 12-month follow-up
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
Health-related quality of life
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
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
Anxiety symptoms
Self-reported anxiety symptoms assessed with the General Anxiety Disorder 7 (GAD-7) screener at baseline, 3-, 6-, and 12-month follow-up
Time frame: Baseline, 3 months, 6 months, and 12 months after baseline
Psychosocial functioning
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
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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
...and 1 more locations
Time frame: 6 months and 12 months after baseline
Cost of health care utilization
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
Time frame: Baseline, 6 months, and 12 months after baseline
Cost-effectiveness
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
Time frame: Baseline, 6 months, and 12 months after baseline