Telephone-administered Relapse Prevention for Depression

Depressive Disorder Clinical Trial

— NaTel  

Official title:

Telephone-administered Cognitive-behavioral Relapse Prevention for Patients With Chronic and Recurrent Depression: A Multi-center Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219879
• Other study ID #: 100019_166009 / 1
• Status: Completed
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: April 8, 2023

Study information

• Verified date: July 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: April 8, 2023
• Est. primary completion date: April 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Recurrence

Intervention

Behavioral:
• Telephone-administered continuation therapy
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.

Other:
• Usual care
Usual care without any study-related intervention

Locations

Country	Name	City	State
Germany	Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart	Stuttgart
Switzerland	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
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	Zürich
Switzerland	Praxisstelle Psychotherapie, Universität Zürich	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Universitätsklinikum Hamburg-Eppendorf, University Hospital, Zürich

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Treatment satisfaction	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	Depressive symptoms	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Brief abstract of the trial