Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| University Hospital, Zürich | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone-administered continuation therapy | Experimental | Cognitive-behavioral continuation therapy (T-CT) delivered over the telephone by trained psychotherapist |
|
| Usual care | Active Comparator | Treatment as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-administered continuation therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months, 12 months, and 18 months after baseline |
| Depressive symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| T-CT acceptability | Satisfaction with and acceptability of the telephone-intervention from therapist and participant perspective at 6-month follow-up (T-CT group only) assessed with a customized self-report evaluation questionnaire | 6 months after baseline |
| Treatment satisfaction |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Birgit Watzke, Prof | University of Zurich | Principal Investigator |
| Markus Wolf, PhD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart | Stuttgart | Germany | ||||
Not provided
| Label | URL |
|---|---|
| Brief abstract of the trial | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Usual care | Other | Usual care without any study-related intervention |
|
|
Self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3-, 6-, and 12-month follow-up |
| 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 | 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 | 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 | 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 | 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 | Baseline, 6 months, and 12 months after baseline |
General treatment satisfaction from participant perspective assessed with Client Satisfaction Questionnaire (ZUF-8) at baseline (both groups) and 6-month follow-up (T-CT group only) |
| Baseline, and 6 months after baseline |
| Self-confidence | Participants' self-reported general levels of confidence assessed at baseline, 6- and 12-month follow-up | Baseline, 6 months, and 12 months after baseline |
| Physical activity | Participants' levels of physical activity assessed with the International Physical Activity Questionnaire Short Form (IPAC-SF) at baseline, 6- and 12-month follow-up | Baseline, 6 months, and 12 months after baseline |
| Self-efficacy for depression self-management | Self-efficacy for depression self-management assessed via self-report questionnaire at baseline, 3-, 6- and 12-month follow-up | Baseline, 3 months, 6 months, and 12 months after baseline |
| Self-management behaviors | Depression-related self-management behaviors assessed via self-report questionnaire at baseline, 3-, 6-, and 12-month follow-up | Baseline, 3 months, 6 months, and 12 months after baseline |
| Interpersonal emotion regulation skills | Participants' interpersonal emotion regulation skills assessed with the Interpersonal Emotion Regulation Questionnaire (IERQ) at baseline, 6- and 12-month follow-up | Baseline, 6 months, and 12 months after baseline |
| Therapeutic alliance | Therapeutic alliance assessed with the Working Alliance Questionnaire-short revised (WAI-SR) from therapist and participant perspective assessed at baseline (both groups), as well as 3- and 6-month follow-up (T-CT group only) | Baseline, 3 months, and 6 months after baseline |
| Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern |
| Bern |
| Switzerland |
| Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG | Brugg | Switzerland |
| Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG | Gais | Switzerland |
| Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR | Herisau | Switzerland |
| Klinik SGM Langenthal | Langenthal | 4900 | Switzerland |
| Zentrum für seelische Gesundheit, Privatklinik Meiringen | Meiringen | 3860 | 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 |
| Praxisstelle Psychotherapie, Universität Zürich | Zurich | Switzerland |