The WORKER Study: Escitalopram and Telephone-based Cognitive Behaviour Therapy (CBT) for Depressed Working People
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study will investigate the additional benefits of telephone-based cognitive behavioral
      therapy (Tel-CBT) as added treatment to an antidepressant (escitalopram) in working people
      with major depressive disorder (MDD) versus treatment with escitalopram alone. Outcomes will
      include depression symptom rating scales and measures of work absence and productivity. The
      hypothesis is that Tel-CBT and escitalopram will result in better outcomes than escitalopram
      alone in working patients with MDD.
    

Detailed description: 
      Rationale CBT is recognized as an effective psychological treatment for MDD. However, there
      are still considerable barriers to access CBT. Newer methods of delivering CBT, such as over
      the telephone (Tel-CBT), allow for greater access and convenience, at potentially lower cost.
      This is especially relevant for working people because the service can be delivered during
      evenings and weekends, so they do not need to leave work to attend clinic appointments. Ease
      of access is also important for rural settings where distance to health facilities can be a
      barrier to care. The ease of delivery of Tel-CBT, both in setup and maintenance costs, may
      also make it an important component of enhanced support for primary care. Preliminary studies
      have shown that addition of Tel-CBT leads to better outcomes than usual care alone (Simon et
      al, 2004; Wang et al, 2007).

      This study will investigate the added value of Tel-CBT as adjunctive treatment to an
      antidepressant (escitalopram) in working people with MDD versus treatment with escitalopram
      alone, focusing on work-related outcomes. Escitalopram offers advantages as a first-choice
      treatment for depressed working people, given its superior efficacy compared to other
      antidepressants, excellent tolerability and simplicity of use for family physicians.
      Observational studies have shown significant reductions in sick leave when depressed patients
      are treated with escitalopram (Winkler et al, 2007). Outcome will be rigorously evaluated by
      assessing absenteeism and work productivity, response and remission rates, and quality of
      life, after acute (3 month) treatment and longer-term (6 month) follow-up.

      Research Method This is a 6-month, multi-centre, single-blind (rater), randomized,
      parallel-design study to assess the efficacy of escitalopram and Tel-CBT in the treatment of
      working subjects with MDD, compared to treatment with escitalopram alone. A total of 150
      depressed patients meeting entry criteria will be enrolled over a 1 year period.

      Eligible patients will be treated with escitalopram 10-20 mg/d for the entire treatment
      period (6 months). Patients will be randomized to addition of telephone-based CBT with 8
      sessions conducted over a 3 month period, or to a (placebo) control condition of reminder
      telephone calls. Outcomes (HAM-D, MADRS) will be primarily assessed over the telephone by
      raters blind to treatment assignment. Other outcome measures will be assessed by
      patient-rated questionnaires administered over the internet using a secure web site, and by
      ratings from the treating physician (CGI and adverse events).

      Statistical Analysis All randomized subjects who have at least one follow-up visit will be
      included in the analysis based on intent-to-treat. Ineligible subjects who are
      inappropriately randomized will be excluded from the analysis. Missing data will be imputed
      using last observation carried forward (LOCF). For the analyses the treatment variables will
      remain coded and the analysts and investigators will remain blinded to variable identity
      during analysis and interpretation.

      The pre-specified primary efficacy endpoint is the adjusted mean change from baseline to
      endpoint (12 weeks) in the HAM-D score using LOCF. All comparisons will be analyzed using
      ANCOVA adjusting for baseline value and centre. The secondary outcomes will also be analyzed
      using a similar analysis, when appropriate. Post hoc analyses will also examine observed case
      data. Categorical data (such as proportions of the sample with adverse events) will be
      analyzed using chi-square tests or Fisher's test where cell sizes warrant.
    

Intervention name(s): Telephone-based Cognitive Behaviour Therapy (CBT); Telephone reminder calls
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Telephone-based CBT: Eight sessions of telephone-based CBT (Tel-CBT) will be delivered over 8-10 weeks, based on a published manual (Simon et al, 2004). Tel-CBT has been modified to be briefer than traditional CBT (30-40 minutes instead of 60 minutes per session) and will be offered at convenient times (including evening sessions). The initial Tel-CBT session will occur within 2 weeks of randomization, with subsequent sessions occurring every 1-2 weeks depending on scheduling and patient preference. The initial session focuses on motivation enhancement exercises, subsequent sessions emphasize identifying, challenging and distancing from negative thoughts, and the final session focuses on a personal care plan and self-management skills.; Telephone reminder calls: Weekly telephone calls for 8 weeks to inquire on progress and remind patients to take their medications properly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; occupational function; rating scales; RCT; cognitive behaviour therapy; CBT; escitalopram; antidepressants