The WORKER Study: Escitalopram and Telephone-based Cognitive Behaviour Therapy (CBT) for Depressed Working People

NCT00702598 | Completed DMC

• 1 other identifier: H07-03029
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Depression; occupational function; rating scales; RCT; cognitive behaviour therapy; CBT; escitalopram; antidepressants

Outcome Measures

Primary Outcomes (1)

• Change in adjusted HAM-D and MADRS scores at 3 month followup

  6 months

Secondary Outcomes (1)

• At 3 and 6 month followup: clinical response and remission rates, absenteeism and work productivity, adverse events, quality of life, and cost-effectiveness.

  6 months

Study Arms (2)

1

EXPERIMENTAL

Telephone-based Cognitive Behaviour Therapy

Behavioral: Telephone-based Cognitive Behaviour Therapy (CBT)

2

PLACEBO COMPARATOR

Telephone reminder calls

Behavioral: Telephone reminder calls

Interventions

Telephone-based Cognitive Behaviour Therapy (CBT) BEHAVIORAL

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.

1

Telephone reminder calls BEHAVIORAL

Telephone reminder calls: Weekly telephone calls for 8 weeks to inquire on progress and remind patients to take their medications properly

2

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female outpatients aged 18-65 years.
• Patients will meet DSM-IV criteria for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998).
• Currently employed (or off work for 2 weeks or less, and expecting to return to work at the start of study).
• A score of 18 or greater on the self-rated version of the MADRS, indicating at least moderately severe depression.
• Competency to give informed consent.

You may not qualify if:

• Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception.
• Serious suicidal risks as judged by the study doctor.
• The following DSM-IV diagnoses (to ensure a homogenous diagnostic group): Organic mental disorders; Substance abuse/dependence, including alcohol, active within the last year; Schizophrenia, Paranoid or Delusional Disorders; Other Psychotic disorders; Panic disorder; Generalized Anxiety Disorder; Obsessive-Compulsive Disorder, or Post Traumatic Stress Disorder, if a primary diagnosis; Bipolar Disorder;Bulimia Nervosa; Anorexia Nervosa.
• Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized.
• Regular or current use of other psychotropic drugs.
• Use of monoamine oxidase inhibitors within 14 days of Visit 1, fluoxetine within 5 weeks of Visit 1, and other antidepressants within 7 days of Visit 1 (to ensure adequate drug washouts prior to starting escitalopram).
• Previous use of escitalopram.
• Treatment resistance in the current episode, as defined by failure (lack of clinically significant response) of two or more antidepressants given at therapeutic doses for at least 6 weeks.
• Patients who start formal psychotherapy (e.g. cognitive-behavioural or interpersonal psychotherapy) within 3 months of Visit 1, or who plan to initiate such psychotherapy during this study.
• Patients involved in any other form of treatment for depression.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC Hospital Mood Disorders Centre

Vancouver, British Columbia, V6T 2A1, Canada

Location

Related Publications (4)

• 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.

  PMID: 15328325 BACKGROUND

• Wang PS, Simon GE, Avorn J, Azocar F, Ludman EJ, McCulloch J, Petukhova MZ, Kessler RC. Telephone screening, outreach, and care management for depressed workers and impact on clinical and work productivity outcomes: a randomized controlled trial. JAMA. 2007 Sep 26;298(12):1401-11. doi: 10.1001/jama.298.12.1401.

  PMID: 17895456 BACKGROUND

• Winkler D, Pjrek E, Moser U, Kasper S. Escitalopram in a working population: results from an observational study of 2378 outpatients in Austria. Hum Psychopharmacol. 2007 Jun;22(4):245-51. doi: 10.1002/hup.839.

  PMID: 17443491 BACKGROUND

• Lam RW, Parikh SV, Ramasubbu R, Michalak EE, Tam EM, Axler A, Yatham LN, Kennedy SH, Manjunath CV. Effects of combined pharmacotherapy and psychotherapy for improving work functioning in major depressive disorder. Br J Psychiatry. 2013 Nov;203(5):358-65. doi: 10.1192/bjp.bp.112.125237. Epub 2013 Sep 12.

  PMID: 24029535 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Raymond W. Lam, MD, FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Sagar V. Parikh

  University of British Columbia

  STUDY DIRECTOR

• Erin E. Michalak

  University of British Columbia

  STUDY DIRECTOR

• Kevin Solomons

  University of British Columbia

  STUDY DIRECTOR

• Sidney H. Kennedy, Ph.D

  University of British Columbia

  STUDY DIRECTOR

• Edwin M. Tam

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 9, 2012

Record last verified: 2012-05

Locations

CA (1)