NCT02667366

Brief Summary

The aim of the study is the examination of effectiveness and cost-effectiveness of a telephone-based psychotherapy (Tel-PT) for depression compared to treatment as usual in primary care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

December 3, 2015

Last Update Submit

October 11, 2018

Conditions

Depression

Keywords

mild and moderate depression

Outcome Measures

Primary Outcomes (1)

  • Change in depressive symptoms

    The change in depressive symptoms will be assessed with the German version of Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, \& Herzog 2002).

    t0 (baseline) and t2 (12 months after baseline)

Secondary Outcomes (6)

  • Change in depressive symptoms

    t0 (baseline) and t1 (four months after baseline)

  • Response

    t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)

  • Change in health-related quality of life

    t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)

  • Self-efficacy for management and relapse prevention in depression

    t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)

  • Cost-effectiveness

    t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)

  • +1 more secondary outcomes

Other Outcomes (4)

  • Acceptance and satisfaction with the intervention

    t1 (four months after baseline)

  • Process and structural variable

    t1 (four months after baseline), t2 (12 months after baseline)

  • Process and structural variable

    t1 (four months after baseline), t2 (12 months after baseline)

  • +1 more other outcomes

Study Arms (2)

Tel-PT

EXPERIMENTAL

Tel-PT receives a manualized short-term CBT. Treatment consists of one initial face-to-face appointment and 8-12 subsequent telephone sessions between patient and licensed therapist. Each telephone contact lasts between 20 and 30 minutes and take place on a weekly and later biweekly basis.

Behavioral: Tel-PT

TAU and text messages

ACTIVE COMPARATOR

Control Group receives treatment as usual and additionally weekly text messages containing general information about depression.

Behavioral: TAU and text messages

Interventions

Tel-PTBEHAVIORAL
Tel-PT
TAU and text messagesBEHAVIORAL
TAU and text messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PHQ-9 score of \> 5 and ≤15.
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Minimum age of 18 years
  • Diagnosis of mild to moderate depression according to ICD-10 (F32.0, F32.1, F33.0, F33.1)

You may not qualify if:

  • Patients currently being in psychotherapeutic treatment or treatment in past three months
  • Suicidal tendencies or suicidality
  • Insufficient knowledge of German language
  • Health condition that does not allow questionnaire completion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8050, Switzerland

Location

Related Publications (7)

  • Löwe, B, Spitzer, RL, Zipfel, S, & Herzog, W. Gesundheitsfragebogen für Patienten (PHQ-D): Manual und Testunterlagen. Pfizer. Karlsruhe: 2002.

    BACKGROUND

  • Watzke B, Heddaeus D, Steinmann M, Konig HH, Wegscheider K, Schulz H, Harter M. Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care. BMC Psychiatry. 2014 Aug 20;14:230. doi: 10.1186/s12888-014-0230-y.

    PMID: 25182269BACKGROUND

  • Simon GE, Ludman EJ, Tutty S, Operskalski B, Von Korff M. Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: a randomized controlled trial. JAMA. 2004 Aug 25;292(8):935-42. doi: 10.1001/jama.292.8.935.

    PMID: 15328325BACKGROUND

  • Bush, T, Russo, J, Ludman, E, Lin, E, Von Korff, M, Simon, G, Walker, E. Perceived self-efficacy for depression self-management. A reliable and valid self-report measure with predictive validity: Poster presentation at the American Psychological Society Meeting, June 2001. Toronto, Canada.

    BACKGROUND

  • Bullinger, M, & Kirchberger, I. Fragebogen zum Gesundheitszustand. Hogrefe. Göttingen: 1998.

    BACKGROUND

  • Haller E, Besson N, Watzke B. "Unrigging the support wheels" - A qualitative study on patients' experiences with and perspectives on low-intensity CBT. BMC Health Serv Res. 2019 Oct 9;19(1):686. doi: 10.1186/s12913-019-4495-1.

    PMID: 31597555DERIVED

  • Watzke B, Haller E, Steinmann M, Heddaeus D, Harter M, Konig HH, Wegscheider K, Rosemann T. Effectiveness and cost-effectiveness of telephone-based cognitive-behavioural therapy in primary care: study protocol of TIDe - telephone intervention for depression. BMC Psychiatry. 2017 Jul 19;17(1):263. doi: 10.1186/s12888-017-1429-5.

    PMID: 28724423DERIVED

MeSH Terms

Conditions

DepressionLymphoma, Follicular

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Birgit Watzke, Prof

    University of Zurich, Department of Clinical Psychology and Psychotherapy Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

January 28, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

CH(1)