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Trial record 4 of 1177 for:    Recruiting, Not yet recruiting Studies | depression

Effectiveness and Cost-effectiveness of Telephone-delivered Psychotherapy for Depression in Primary Care

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ClinicalTrials.gov Identifier: NCT02667366
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : October 25, 2016
Sponsor:
Collaborator:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Tel-PT Behavioral: TAU and text messages Not Applicable

Detailed Description:

The overall purpose of the study is to examine the effectiveness of telephone psychotherapy (Tel-PT) for the treatment of mild to moderate depression on different outcome-levels and under clinically representative conditions in Swiss primary health care. The randomized-controlled trial (RCT) will evaluate the primary hypothesis that Tel-PT is more effective than routine primary care (i.e. treatment as usual, TAU), more specifically, that it leads to significant higher reduction in depression severity than TAU at follow-up.

The intervention group (IG) receives a manualized short-term cognitive behavioral treatment, which is the adapted German version of the program "Creating a balance" developed in the USA. The therapy consists of one face-to-face and 8-12 telephone contacts and is carried out by a licensed psychotherapist.

More concrete, recruitment and inclusion of the patients will be carried out by the participating general practitioners (GPs). GPs will be instructed to screen patients at risk for depression, especially those revealing diffuse somatic symptoms and suffering from chronic diseases. If positively screened, patient`s depressive symptoms are assessed with Patient Health Questionnaire (PHQ-9) and diagnosed according to ICD-10.

All GPs will receive an initial training prior to their participation, providing them with study information and procedures as well as training in screening procedure, psychodiagnostics and study enrolment.

Eligible patients are provided with detailed study information and asked to participate. Subsequently, patients will give informed consent. Patients will then be included into the study and fill out the baseline questionnaires (t0). After that, randomization will be carried out at the University of Zurich, based on an appropriately created computer algorithm. Both GPs and patients are informed about the results by the study team within two days. Subsequently, patients in control group (CG) will receive regular text messages and patients in the intervention group (IG) will be called by the study therapist to schedule an initial appointment.

In case of positive results, the overarching objective is the optimization of mental health services for depressed patients by implementing an evidence-based, accessible and cost-effective treatment option into primary care.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Access to Evidence-based Treatment for Depression: Effectiveness and Cost-effectiveness of Telephone-delivered Cognitive Behavioral Therapy (CBT) in Primary Care
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tel-PT
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
Active Comparator: TAU and text messages
Control Group receives treatment as usual and additionally weekly text messages containing general information about depression.
Behavioral: TAU and text messages



Primary Outcome Measures :
  1. Change in depressive symptoms [ Time Frame: t0 (baseline) and t2 (12 months after baseline) ]
    The change in depressive symptoms will be assessed with the German version of Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, & Herzog 2002).


Secondary Outcome Measures :
  1. Change in depressive symptoms [ Time Frame: t0 (baseline) and t1 (four months after baseline) ]
    The change in depressive symptoms will be assessed with the German version of Patient Health Questionnaire (PHQ-9; Löwe, Spitzer, Zipfel, & Herzog 2002).

  2. Response [ Time Frame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline) ]
    Response defined as 50% reduction in the PHQ-9.

  3. Change in health-related quality of life [ Time Frame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline) ]
    Change in health-related quality of life is measured with the 12-Item Short Form Health Survey (SF-12; Bullinger & Kirchberger, 1998).

  4. Self-efficacy for management and relapse prevention in depression [ Time Frame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline) ]
    Depression self-efficacy scale for management and relapse prevention (Bush et al., 2001).

  5. Cost-effectiveness [ Time Frame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline) ]
    Health care utilization and productivity loss will be measured with an adapted version of the Client Sociodemographic and Service Receipt Inventory (CSSRI; Chisholm et al., 2000). For Switzerland, country-specific unit costs will be employed to calculate direct and indirect costs.

  6. Cost-effectiveness [ Time Frame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline) ]
    Health-related quality of life for the economic analyses will be measured using the EQ-5D-5L (The EuroQuol Group, 1990), Quality-adjusted life years (QALYs) based on the EQ-5D index will be determined and the incremental cost-effectiveness ratio (ICER) will be computed.


Other Outcome Measures:
  1. Acceptance and satisfaction with the intervention [ Time Frame: t1 (four months after baseline) ]
    Patients' and therapists' acceptance and satisfaction with the intervention will be assessed by a self-constructed questionnaire.

  2. Process and structural variable [ Time Frame: t1 (four months after baseline), t2 (12 months after baseline) ]
    Mean duration of telephone contacts

  3. Process and structural variable [ Time Frame: t1 (four months after baseline), t2 (12 months after baseline) ]
    Mean number of telephone contacts.

  4. Process and structural variable [ Time Frame: t1 (four months after baseline), t2 (12 months after baseline) ]
    Dropout rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667366


Contacts
Contact: Elisa Haller, MSc 004144 635 7335 elisa.haller@uzh.ch

Locations
Switzerland
University of Zurich Recruiting
Zurich, Switzerland, 8050
Contact: Elisa Haller, MSc    +41 44 635 7335    elisa.haller@uzh.ch   
Sponsors and Collaborators
University of Zurich
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Birgit Watzke, Prof University of Zurich, Department of Clinical Psychology and Psychotherapy Research

Publications:
Löwe, B, Spitzer, RL, Zipfel, S, & Herzog, W. Gesundheitsfragebogen für Patienten (PHQ-D): Manual und Testunterlagen. Pfizer. Karlsruhe: 2002.
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.
Bullinger, M, & Kirchberger, I. Fragebogen zum Gesundheitszustand. Hogrefe. Göttingen: 1998.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02667366     History of Changes
Other Study ID Numbers: BW-0417
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by University of Zurich:
mild and moderate depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders