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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02667366
Enrollment
56
Registered
2016-01-28
Start date
2016-01-31
Completion date
2019-03-31
Last updated
2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

mild and moderate depression

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.

Interventions

BEHAVIORALTel-PT
BEHAVIORALTAU and text messages

Sponsors

Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in depressive symptomst0 (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

MeasureTime frameDescription
Change in depressive symptomst0 (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).
Responset0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)Response defined as 50% reduction in the PHQ-9.
Change in health-related quality of lifet0 (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).
Self-efficacy for management and relapse prevention in depressiont0 (baseline), t1 (four months after baseline), t2 (12 months after baseline)Depression self-efficacy scale for management and relapse prevention (Bush et al., 2001).
Cost-effectivenesst0 (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.

Other

MeasureTime frameDescription
Acceptance and satisfaction with the interventiont1 (four months after baseline)Patients' and therapists' acceptance and satisfaction with the intervention will be assessed by a self-constructed questionnaire.
Process and structural variablet1 (four months after baseline), t2 (12 months after baseline)Mean duration of telephone contacts

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026