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

Depression Clinical Trial

Official title:

Improving Access to Evidence-based Treatment for Depression: Effectiveness and Cost-effectiveness of Telephone-delivered Cognitive Behavioral Therapy (CBT) in Primary Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02667366
• Other study ID #: BW-0417
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2019

Study information

• Verified date: October 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Tel-PT

• TAU and text messages

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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

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.

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

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. — View Citation

Watzke B, Heddaeus D, Steinmann M, König HH, Wegscheider K, Schulz H, Härter 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptance and satisfaction with the intervention	Patients' and therapists' acceptance and satisfaction with the intervention will be assessed by a self-constructed questionnaire.	t1 (four months after baseline)
Other	Process and structural variable	Mean duration of telephone contacts	t1 (four months after baseline), t2 (12 months after baseline)
Other	Process and structural variable	Mean number of telephone contacts.	t1 (four months after baseline), t2 (12 months after baseline)
Other	Process and structural variable	Dropout rate	t1 (four months after baseline), t2 (12 months after baseline)
Primary	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	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 t1 (four months after baseline)
Secondary	Response	Response defined as 50% reduction in the PHQ-9.	t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Secondary	Change in health-related quality of life	Change in health-related quality of life is measured with the 12-Item Short Form Health Survey (SF-12; Bullinger & Kirchberger, 1998).	t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Secondary	Self-efficacy for management and relapse prevention in depression	Depression self-efficacy scale for management and relapse prevention (Bush et al., 2001).	t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Secondary	Cost-effectiveness	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.	t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Secondary	Cost-effectiveness	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.	t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)