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Differences in quality of life outcomes among depressed spinal cord injury trial participants . OBJECTIVE To assess the role that treatment response plays in a randomized controlled trial of an antidepressant among people with spinal cord injury ( SCI ) diagnosed with major depressive disorder ( MDD ) in explaining quality of life ( QOL ) , assessed both globally as life satisfaction and in terms of physical and mental health-related QOL . DESIGN Multivariable analyses were conducted , controlling for demographic , neurologic , and participatory factors and perceived functional limitations . SETTING Rehabilitation centers . PARTICIPANTS Of the 133 persons who were randomized into the Project to Improve Symptoms and Mood after Spinal Cord Injury randomized controlled trial , 124 participated in this study . All participants were between the ages of 18 and 64 years , at least 1 month post-SCI , met the Diagnostic and Statistical Manual of Mental Disorders , 4th edition , criteria for MDD , and completed the core measures used in this study . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The Satisfaction with Life Scale and the physical and mental component summary scores of the Medical Outcomes Study 12-Item Short-Form Health Survey . RESULTS Reduction in depressive symptoms over the course of a 12-week trial was predictive of increased QOL , which was measured as life satisfaction and mental well-being , within the context of other explanatory factors . However , reduction in symptoms did not explain differences in physical well-being among those with MDD . Perceived functional disability explained all 3 indices of QOL . CONCLUSIONS Greater recognition has been given to QOL outcomes as endpoints of clinical trials because these often reflect participants ' reported outcomes . Our findings support the association of QOL to the reduction of depression symptoms among trial participants . This association differs depending on how QOL is defined and measured , with stronger relations observed with life satisfaction and mental well-being among those diagnosed with MDD . The lack of association between depression and physical well-being may be explained by participants ' subjective interpretation of physical well-being after SCI and their expectations and perceptions of improved physical health-related QOL based on the use of assistive technology . Consistent with our findings , pain is likely to play a role in decreasing physical QOL among those with incomplete injuries . Practicing caution is suggested in using physical well-being as an endpoint in trials among people with SCI .
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Intervention_Pharmacological
antidepressant
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Intervention_Educational
Project to Improve Symptoms and Mood
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Outcome_Physical
The
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Outcome_Mental
Satisfaction with Life Scale
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Outcome_Physical
and the physical and
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Outcome_Mental
mental component summary scores of the Medical Outcomes Study 12-Item Short-Form Health Survey
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Outcome_Physical
.
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Outcome_Mental
Reduction in depressive symptoms
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Outcome_Mental
QOL , which was measured as life satisfaction and mental well-being
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Outcome_Other
reduction in symptoms
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Outcome_Mental
Perceived functional disability
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Participant_Condition
depressed spinal cord injury
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Participant_Condition
spinal cord injury ( SCI )
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Participant_Condition
major depressive disorder ( MDD
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Participant_Sample-size
133
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Participant_Condition
Spinal Cord Injury
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Participant_Sample-size
124
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Participant_Age
18
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Participant_Age
64
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Participant_Condition
incomplete injuries
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Participant_Condition
SCI