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Collaborative Care in the Treatment of Depressive Disorder Containing an Antidepressant Algorithm and PST; a Multicentre Cluster Randomized Trial in Primary Care

Collaborative Care in the Treatment of Depressive Disorder Containing an Antidepressant Algorithm and PST; a Multicentre Cluster Randomized Trial in Primary Care - CC:DIP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29861
Enrollment
240
Registered
2006-12-15
Start date
2007-10-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Depression Major Depressive Disorder

Interventions

A collaborative care framework is used with the following elements: -Problem Solving Treatment (PST) -An antidepressant Algorithm -Contracting -Techniques enhancing adherence and complience -Caseman

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: A score of 15 or higher on the PHQ9, a short questionnaire that screens for Major Depressive Episode. The symptoms have to be present for at least six weeks, or have to cause marked dysfunctioning (for instance problems at work or sleeping problems).

Exclusion criteria

Exclusion criteria: Patients with high suicidal risk, those currently experiencing a psychotic episode, those who have dementia or those who are addicted to alcohol or narcotics are excluded from the study (they are however referred to the general practitioner in case of high suicide risk or a suggestion is given for another form of help).

Design outcomes

Primary

MeasureTime frame
Reduction of depressive symptoms remission. The severity of the symptoms is measured by the Inventory for Depressive Symptomatology-Self Report (IDS-SR) and the Patient Health Questionnaire depression subscale (PHQ9). The IDS-SR can be used for a global assessment of depressive symptoms. The instrument consists of 30 questions on a *0-3 scale*. The PHQ9 is a brief but valid instrument that scores each of the DSM-IV criteria from *0* (not at all) to *3* (nearly every day). Remission -reduction of DSM-IV criteria below threshold for a depressive disorder diagnosis [ref APA]- is measured by the MINI interview at the end of the intervention period (T1) and 12 months (T3), and with the PHQ9 -cut-off score below 15-.

Secondary

MeasureTime frame
Cost utility, next to the improvement of severity of symptoms, the cost utility of collaborative care compared to CAU is assessed in this design. Therefore, an estimation of the direct medical costs and the costs due to production losses (productivity costs) is made. Data for estimating the costs are collected by using the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P). Quality of life is assessed by using the EQ-5D and the SF-36, which are validated tools for measuring general health*related quality of life. The cost utility is evaluated by relating the difference in direct medical costs per patient receiving collaborative care or CAU to the difference in terms of Quality Adjusted Life Years gained (QALY), which yields a cost per QALY estimate. Furthermore, we also estimate the cost per QALY including the productivity costs. *Additional outcome measures and effectmodifcators: 1. Physical illness, as measured by the CBS-list, a questionnaire by the Central Bureau of Statistics (CBS) in the Netherlands containing 28 chronic conditions ranging from diabetes type II to Multiple Sclerosis. 2. Disability caused by the disorder, evaluated with the World Health Organization Disability Assessment Survey II (WHO-DAS-II). WHO-DAS-II is developed to assess the activity limitations and participation restrictions actually experienced by an individual, irrespective of diagnosis. It has six major domains: understanding and communicating with the world, moving and getting around, self-care, getting along with people, life activities, and participation in society. The instrument consists of 32 questions. 3. Adherence and compliance, assessed by the number of drop outs in the intervention group compared to the CAU group. Possible preferences of the patient, assessed by the choices of patients within the intervention group. 4. Attitude of the GP towards the treatment of depressive disorder, measured with the Depression Atti

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)