Clinical trial NCT02667366: Effectiveness and Cost-effectiveness of Telephone-delivered Psychotherapy for Depression in Primary Care
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: mild and moderate depression
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2016-01-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: t0 (baseline) and t2 (12 months after baseline)
Secondary outcomes:
measure: Change in depressive symptoms
timeFrame: t0 (baseline) and t1 (four months after baseline)
measure: Response
timeFrame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
measure: Change in health-related quality of life
timeFrame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
measure: Self-efficacy for management and relapse prevention in depression
timeFrame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
measure: Cost-effectiveness
timeFrame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
measure: Cost-effectiveness
timeFrame: t0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)
Other outcomes:
measure: Acceptance and satisfaction with the intervention
timeFrame: t1 (four months after baseline)
measure: Process and structural variable
timeFrame: t1 (four months after baseline), t2 (12 months after baseline)
measure: Process and structural variable
timeFrame: t1 (four months after baseline), t2 (12 months after baseline)
measure: Process and structural variable
timeFrame: t1 (four months after baseline), t2 (12 months after baseline)
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich, Department of Clinical Psychology and Psychotherapy Research
name: Birgit Watzke, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Löwe, B, Spitzer, RL, Zipfel, S, & Herzog, W. Gesundheitsfragebogen für Patienten (PHQ-D): Manual und Testunterlagen. Pfizer. Karlsruhe: 2002.
citation: 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.
citation: 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.
citation: 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.
citation: Bullinger, M, & Kirchberger, I. Fragebogen zum Gesundheitszustand. Hogrefe. Göttingen: 1998.
citation: 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.
citation: 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.