Depression Clinical Trial
Official title:
Patient Dimensions as Predictors of Response, Relapse and Recurrence Following Cognitive-Behavioral Therapy, Interpersonal Psychotherapy and Pharmacotherapy Treatment of Patients With Major Depression.
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.
The National Institute of Mental Health (NIMH) Treatment of Depression Collaborative
Research Programme (TDCRP) (Elkin et al., 1989; Sotsky et al., 1991) compared three forms of
treatment for depression -- imipramine plus clinical management (IMI-CM), cognitive
behaviour therapy alone (CBT), interpersonal therapy alone (IPT) -- against a placebo
control plus clinical management (PLA-CM) condition. These three treatments were found
equally effective in the treatment of the index episode of depression when compared to the
placebo control (Elkin et al., 1989). The results from the TDCRP study also indicated that
patient characteristics, irrespective of treatment modality, were predictive of treatment
effects. Six patient dimensions -- social dysfunction, cognitive dysfunction, expectation
for improvement, endogenous features, double depression and duration of current episode --
were all found to be significant predictors of outcome (Sotsky et al., 1991). Patient
characteristics were also found to be associated with differential outcome depending on
treatment modality. Elevated social dysfunction, for example, interfered with successful
outcome in IPT, whereas cognitive dysfunction hindered successful outcome with CBT.
Cognitive dysfunction also predicted poor treatment response in the IMI-CM condition.
Cognitive vulnerability would be expected to mediate response to treatment in CBT, as the
presumed mechanism of change is dysfunctional depressogenic cognitions (e.g., Beck et al.,
1979; Whisman, 1993). The finding that cognitive vulnerability was also implicated in
treatment response to a pharmacological intervention is without theoretical explanation or
specific causal agency.
The purpose of the proposed research is to further examine the relationship between
treatment outcomes and patient characteristics associated depression. In particular, the
relationship between treatment outcome and two personality/cognitive characteristics
implicated as vulnerability factors for depression - self-criticism and dependency - will be
explored.
HYPOTHESES/RESEARCH QUESTIONS
Prediction of Treatment Outcome (Objective 1):
Two sets of hypotheses are proposed. In all analyses the DEQ will be used to assess
self-criticism and dependency. The first set of hypotheses involves mode specific treatment
outcomes and the second set of hypotheses address differences in the mechanisms of change
across the treatments.
The first set of hypotheses are: (a) all treatments will be equally effective in the
treatment of the index episode, (b) baseline self-criticism and dependency scores will
predict outcome in all treatments, with higher self-criticism and dependency scores related
to poor outcome, (c) CBT will demonstrate greater specificity for targeting self-criticism
than will either PHT or IPT, (d) IPT will demonstrate greater specificity for treating
interpersonal functioning than will either PHT or CBT, (e) PHT will demonstrate greater
specificity for treating endogenous symptoms than will either CBT or IPT.
The second set of hypotheses are: (a) change in self-criticism scores and dysfunctional
cognitions will mediate a positive treatment response in CBT but not in IPT or PHT, (b)
change in dependency scores and interpersonal deficits will mediate positive treatment
response in IPT but not in CBT or PHT, (c) change in endogeneity will mediate positive
treatment response in PHT but not in CBT or IPT.
Prediction of Relapse and Recurrence (Objective 2):
It is hypothesized that: (a) CBT and IPT will produce a lower rate of relapse and recurrence
than PHT because of the greater reduction in stable dysfunctional cognitions related to
either self-critical and/or interpersonal vulnerabilities; (b) in cases where interpersonal
vulnerabilities are predominant, IPT will produce lower rates of relapse and recurrence than
either CBT and PHT, in cases where self-critical vulnerabilities are predominant, CBT will
produce lower rates of relapse and recurrence than either IPT or PHT.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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