## Protocol Section
### Identification Module
**NCT ID:** NCT03219879

**Acronym:** NaTel

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 100019_166009 / 1
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### Status Module
#### Completion Date
**Date:** 2023-04-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-04-08

**Type:** ACTUAL

#### Start Date
**Date:** 2017-09-29

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2017-07-18
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-20
**Study First Submit QC Date:** 2017-07-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Universitätsklinikum Hamburg-Eppendorf

**Class:** OTHER

**Name:** University Hospital, Zürich

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Zurich

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Depressive Disorder

**Keywords:**

- Relapse prevention

- Persistent depressive disorder

- Recurrent depressive disorder

- Telephone-based intervention

- Cognitive behavioral therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 201

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cognitive-behavioral continuation therapy (T-CT) delivered over the telephone by trained psychotherapist

**Intervention Names:**

- Behavioral: Telephone-administered continuation therapy

**Label:** Telephone-administered continuation therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Treatment as usual

**Intervention Names:**

- Other: Usual care

**Label:** Usual care

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Telephone-administered continuation therapy

**Description:** 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.

**Name:** Telephone-administered continuation therapy

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Usual care

**Description:** Usual care without any study-related intervention

**Name:** Usual care

**Other Names:**

- Treatment as usual (TAU)

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** 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

**Measure:** T-CT acceptability

**Time Frame:** 6 months after baseline

**Description:** 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)

**Measure:** Treatment satisfaction

**Time Frame:** Baseline, and 6 months after baseline

**Description:** Participants' self-reported general levels of confidence assessed at baseline, 6- and 12-month follow-up

**Measure:** Self-confidence

**Time Frame:** Baseline, 6 months, and 12 months after baseline

**Description:** Participants' levels of physical activity assessed with the International Physical Activity Questionnaire Short Form (IPAC-SF) at baseline, 6- and 12-month follow-up

**Measure:** Physical activity

**Time Frame:** Baseline, 6 months, and 12 months after baseline

**Description:** Self-efficacy for depression self-management assessed via self-report questionnaire at baseline, 3-, 6- and 12-month follow-up

**Measure:** Self-efficacy for depression self-management

**Time Frame:** Baseline, 3 months, 6 months, and 12 months after baseline

**Description:** Depression-related self-management behaviors assessed via self-report questionnaire at baseline, 3-, 6-, and 12-month follow-up

**Measure:** Self-management behaviors

**Time Frame:** Baseline, 3 months, 6 months, and 12 months after baseline

**Description:** Participants' interpersonal emotion regulation skills assessed with the Interpersonal Emotion Regulation Questionnaire (IERQ) at baseline, 6- and 12-month follow-up

**Measure:** Interpersonal emotion regulation skills

**Time Frame:** Baseline, 6 months, and 12 months after baseline

**Description:** 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)

**Measure:** Therapeutic alliance

**Time Frame:** Baseline, 3 months, and 6 months after baseline

#### Primary Outcomes

**Description:** 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

**Measure:** Relapse of a major depressive episode

**Time Frame:** 6 months, 12 months, and 18 months after baseline

#### Secondary Outcomes

**Description:** 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

**Measure:** Well-weeks

**Time Frame:** 6 months, 12 months, and 18 months after baseline

**Description:** Self-reported depressive symptoms assessed with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3-, 6-, and 12-month follow-up

**Measure:** Depressive symptoms

**Time Frame:** Baseline, 3 months, 6 months, and 12 months after baseline

**Description:** 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

**Measure:** Health-related quality of life

**Time Frame:** Baseline, 3 months, 6 months, and 12 months after baseline

**Description:** Self-reported anxiety symptoms assessed with the General Anxiety Disorder 7 (GAD-7) screener at baseline, 3-, 6-, and 12-month follow-up

**Measure:** Anxiety symptoms

**Time Frame:** Baseline, 3 months, 6 months, and 12 months after baseline

**Description:** 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

**Measure:** Psychosocial functioning

**Time Frame:** 6 months and 12 months after baseline

**Description:** 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

**Measure:** Cost of health care utilization

**Time Frame:** Baseline, 6 months, and 12 months after baseline

**Description:** 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

**Measure:** Cost-effectiveness

**Time Frame:** Baseline, 6 months, and 12 months after baseline

### Eligibility Module

**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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stuttgart

**Country:** Germany

**Facility:** Institut für Klinische Psychologie, Krankenhaus Bad Cannstatt, Klinikum Stuttgart

**Location 2:**

**City:** Bern

**Country:** Switzerland

**Facility:** Universitätsklinik für Psychiatrie und Psychotherapie, Universität Bern

**Location 3:**

**City:** Brugg

**Country:** Switzerland

**Facility:** Zentrum Psychiatrie und Psychotherapie stationär, Psychiatrische Dienste Aargau AG

**Location 4:**

**City:** Gais

**Country:** Switzerland

**Facility:** Zentrum für Psychiatrie und Psychotherapie, Klinik Gais AG

**Location 5:**

**City:** Herisau

**Country:** Switzerland

**Facility:** Klinik für Psychiatrie und Psychotherapie, Psychiatrisches Zentrum AR

**Location 6:**

**City:** Langenthal

**Country:** Switzerland

**Facility:** Klinik SGM Langenthal

**Zip:** 4900

**Location 7:**

**City:** Meiringen

**Country:** Switzerland

**Facility:** Zentrum für seelische Gesundheit, Privatklinik Meiringen

**Zip:** 3860

**Location 8:**

**City:** Oberwil

**Country:** Switzerland

**Facility:** Zentrum für Psychiatrie und Psychotherapie Klinik Zugersee, Triaplus AG

**Location 9:**

**City:** Zug

**Country:** Switzerland

**Facility:** Psychiatrische und Psychotherapeutische Spezialklinik für Frauen, Klinik Meissenberg AG

**Location 10:**

**City:** Zürich

**Country:** Switzerland

**Facility:** Klinik für Psychiatrie und Psychotherapie, UniversitätsSpital Zürich

**Location 11:**

**City:** Zürich

**Country:** Switzerland

**Facility:** Praxisstelle Psychotherapie, Universität Zürich

#### Overall Officials

**Official 1:**

**Affiliation:** University of Zurich

**Name:** Birgit Watzke, Prof

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Zurich

**Name:** Markus Wolf, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Brief abstract of the trial

**URL:** http://www.psychologie.uzh.ch/de/fachrichtungen/klipfor/forschung/forschungsprojekte.html

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Relapse

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012008

- Term: Recurrence

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-24
