Stress Generation and Recurrent Depression: The Role of Differential Treatment Response
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Purpose
Depression affects over one million people in Canada, resulting in $14.4 billion per year in costs to Canadian society. In order to prevent this often lifelong disorder, it is critically important to identify risk factors for the recurrence of depression. A crucial force in maintaining depression is the generation of stressful life events. That is, individuals who have a history of depression are likely to generate the very events that precipitate future depressive episodes (e.g., relationship break-up, fired from job, conflicts with the law) due to negative personality characteristics and disrupted social support networks resulting from previous episodes. This project is the first to test a model that examines the role of negative personality, low social support, and childhood abuse and neglect as risk factors for the generation of stressful life events that predict future depression. We will test this model in a group of patients meeting formal criteria for depression who will be treated and then followed up for 12 months or until depression recurrence. With this long-term design we will be in a unique position to understand how depression is maintained over time, thus suggesting important treatment strategies to prevent depression recurrence.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Major Depressive Disorder |
Behavioral: Cognitive Behavioral Therapy Behavioral: Interpersonal Therapy Drug: Antidepressant medication |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Stress Generation and Recurrent Depression: The Role of Differential Treatment Response |
- Hamilton Rating Scale for Depression [ Time Frame: intermittent ] [ Designated as safety issue: No ]
| Enrollment: | 72 |
| Study Start Date: | July 2001 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Behavioral: Cognitive Behavioral Therapy
All patients randomized to this condition will receive 16 consecutive weeks of manualized cognitive-behaviour therapy provided by either M.S.W or Ph.D. psychotherapists trained and certified in CBT. Treatment will be conducted according to the manualized CBT treatment for depression outlined by Beck and colleagues (Beck et al., 1979), and consistent with the protocol administered in the NIMH study.
|
| Experimental: 2 |
Behavioral: Interpersonal Therapy
All patients randomized to this condition will receive 16 consecutive weeks of manualized interpersonal psychotherapy conducted by M.S.W., Ph.D., or M.Ed. psychotherapists trained and certified in IPT.
|
| Experimental: 3 |
Drug: Antidepressant medication
Patients patients randomized to this condition will be treated for 16 weeks with different classes of anti-depressant medications, using standardized protocols. Patients will receive 16 weeks of treatment with either a SSRI (sertraline or paroxetine) or a SNRI (venlafaxine). The dose range is as follows: sertraline 50-200 mg/day, paroxetine 20-40 mg/day, venlafaxine 75-375 mg/day. Patients unable to continue with the prescribed medication due to side effects and/or lack of response will be prescribed an alternate medication during the first two weeks of the protocol.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meet the criteria for DSM-IV diagnosis of non-psychotic, major depression based on the Structured Interview for DSM-IV, Axis I disorders
- Score > 16 the 17-item Hamilton Rating Scale for Depression
- Ages between 18 and 60
- Are medication-free (i.e., of antidepressants) for a minimum of two weeks prior to treatment are eligible for entry into treatment protocols
- Minimum eight grade education and fluency in reading English
- Ability to give informed consent and complete assessment instruments unassisted
Exclusion Criteria:
a SCID-I diagnosis of:
- Bipolar Disorder (past or present),
- Schizoaffective Disorder,
- Schizophrenia,
- Substance Abuse Disorder (current or within the past 6 months),
- Borderline or Antisocial Personality Disorder,
- Organic Brain Syndrome
- Electroconvulsive Therapy (ECT) within the past 6 months
- Concurrent active medical illness
Contacts and Locations| Canada, Ontario | |
| Centre for Addiction and Mental Health | |
| Toronto, Ontario, Canada, M5T 1R8 | |
| Principal Investigator: | Kate L Harkness, PhD | Queen's University |
More Information
No publications provided
| Responsible Party: | Kate Leslie Harkness, PhD, Queen's University |
| ClinicalTrials.gov Identifier: | NCT00745017 History of Changes |
| Other Study ID Numbers: | 091/2003 |
| Study First Received: | August 28, 2008 |
| Last Updated: | August 29, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre for Addiction and Mental Health:
|
recurrent depression major depressive disorder interpersonal therapy cognitive behavioral therapy |
antidepressant therapies outome predictors personality dimensions |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013