Overall, during the 24 weeks of the study, the patients received a mean of 8.4 clinical management sessions with a psychiatrist (SD=4.3). An “adequate” trial of medication was defined as a period of 4 weeks or longer of at least the minimum targeted dose of a medication (e.g., 150 mg/day of imipramine, 20 mg/day of fluoxetine) (24
). With these criteria, 61 (80%) of the 76 patients received at least one adequate medication trial. Eight (11%) of the 76 patients dropped out of treatment before receiving an adequate trial. All of the remaining seven patients received between one and four trials of antidepressants, but because of side effects and/or noncompliance, they were not receiving the criterion dose for a 4-week period. Of the patients who received at least one adequate trial, 48% (N=29) received one trial, 25% (N=15) received two trials, and the remaining 27% (N=17) had three or more medication trials. There were no significant differences between any treatment groups in the proportion of patients who received an “adequate” medication trial. The patients in the combined cognitive therapy plus pharmacotherapy and the combined cognitive plus family therapy conditions received a mean of 13.0 cognitive therapy sessions (SD=6.0), whereas the patients in the combined family therapy plus pharmacotherapy and the combined cognitive plus family therapy conditions received a mean of 5.1 family therapy sessions (SD=4.3).
Study results can be seen in . Twenty-one percent of the group (N=16) dropped out of treatment, and 24% (N=18) were removed from the study as “treatment failures.” There was a significant linear decrease in Modified Hamilton Rating Scale for Depression scores from discharge to week 24 (γ10=−2.96, t=−5.23, df=75, p<0.001). Furthermore, there was moderate variability in Modified Hamilton Rating Scale for Depression change in score over time (μ1=2.63, χ2=83.61, df=69, p=0.11), suggesting differentiation in score change across individuals. A significant linear decrease in Beck Depression Inventory scores was also observed (γ10=−2.31, t=−2.97, df=75, p<0.01). This decrease also had significant variability (μ1=3.64, χ2=98.88, df=69, p<0.01). Finally, scores on the Modified Scale for Suicidal Ideation did not significantly change over time (γ10=0.73, t=1.13, df=75, p=0.26). Despite this overall stability, there was significant variance in linear change (μ1=2.85, χ2=97.30, df=69, p<0.05). This suggests that scores on the Modified Scale for Suicidal Ideation increased for some individuals and decreased for others, leading to relatively small change overall. Noncompleters reported higher levels of suicidal ideation during hospital admission than completers (γ01=−4.54, t=−5.51, df=74, p<0.05). However, the completers and the noncompleters did not differ in their rates of change in suicidal ideation during the course of treatment (γ11=−0.13, t=−0.10, df=74, n.s.). At the end of treatment, 29% of the group (N=22) met the criteria for improvement, and 16% (N=12) met the criteria for remission.
Baseline, Discharge, and Week-24 Demographic and Clinical Characteristics of Recently Discharged Patients With Major Depression
To summarize, substantial proportions of the patients did not complete the 6-month treatment. Depression scores significantly decreased over time. Not everyone changed similarly because change parameters had moderate variability. Suicidal ideation did not significantly change over time. However, there was significant variability in change in scores on the Modified Scale for Suicidal Ideation, indicating that suicidal ideation changed differently across individuals. Overall rates of improvement and remission were low. We next examined whether treatment allocation could account for individual differences in response over time.
Primary Hypothesis: Matched Treatment
Our primary set of analyses compared the matched and the mismatched subjects across all treatment conditions (cells 1, 3, 6, 8 against cells 2, 4, 5, 7; see ). As can be seen in , these comparisons used the entire group, with the two conditions (matched and mismatched) taking equivalent proportions of each patient subgroup (high versus low cognitive dysfunction, high versus low family impairment) and type of treatment (cognitive therapy, family therapy, and pharmacotherapy alone).
There were no significant differences in Modified Hamilton Rating Scale for Depression scores, Beck Depression Inventory scores, or Modified Scale for Suicidal Ideation scores at discharge between the matched and mismatched groups. Similarly, there were no significant differences between the matched and the mismatched groups in the proportions of treatment failures or dropouts.
Matched treatment led to significantly greater change in score on the Modified Hamilton Rating Scale for Depression than mismatched treatment (γ11=−2.12, t=1.95, df=74, p=0.05, d=0.45). However, treatment matching did not lead to significantly different change in Beck Depression Inventory scores compared to mismatched treatment (γ11=−2.10, t=−1.38, df=74, p=0.58, d=0.32). Similarly, treatment matching did not produce greater change in scores on the Modified Scale for Suicidal Ideation compared to mismatched treatment (γ11=−1.06, t=−0.86, df=74, p=0.39, d=0.20).
At the end of treatment, the matched condition had a significantly higher proportion of patients who improved (χ2=3.9, df=1, p<0.05, d=0.47), but there were no significant differences in the proportion whose illness remitted ().
Proportion of a Group of 76 Recently Discharged Patients Who Improved or Whose Depression Remitted After 24 Weeks
The secondary hypotheses investigated the more specific efficacy of different treatment approaches by comparing the outcome of the patients who received 1) cognitive therapy versus no cognitive therapy (cells 1, 3, 5, 7 versus cells 2, 4, 6, 8) and 2) family therapy versus no family therapy (cells 1, 4, 6, 7 versus cells 2, 3, 5, 8). These comparisons also included the entire group, with each comparison (cognitive therapy versus no cognitive therapy; family therapy versus no family therapy) taking equivalent proportions of each patient subgroup and other types of treatments. We do not report analyses of specific treatment conditions—pharmacotherapy, combined cognitive therapy and pharmacotherapy, etc. Although the data are potentially interesting, these comparisons between individual treatment conditions either 1) are completely confounded with patient grouping and/or 2) are composed of only two of the four patient groups ().
There were no significant differences in Modified Hamilton Rating Scale for Depression, Beck Depression Inventory, or Modified Scale for Suicidal Ideation scores at discharge between the groups with family therapy and no family therapy. The patients who received family therapy had a significantly lower proportion who were treatment failures (χ2=5.8, df=1, p<0.05, d=0.57) than those who did not. But the two groups did not differ in the proportion who were dropouts.
Linear change in Modified Hamilton Rating Scale for Depression scores was significantly greater for family therapy than for no family therapy (γ11=−2.19, t=−2.05, df=74, p=0.04, d=0.48). Family therapy also produced a significantly greater decrease in scores on the Modified Scale for Suicidal Ideation across time compared to no family therapy (γ11=−2.70, t=−2.36, df=74, p=0.02, d=0.55). However, inclusion of family therapy produced only a nonsignificant tendency for change in Beck Depression Inventory scores (γ11=−2.58, t=−1.71, df=74, p=0.09, d=0.40).
At the end of treatment, the patients receiving family therapy had significantly higher proportions of patients who improved (χ2=10.1, df=1, p<0.01, d=0.78) and showed a nonsignificant tendency to have higher proportions whose illness remitted (χ2=2.7, df=1, p=0.10, d=0.38) ().
There were no significant differences in Modified Hamilton Rating Scale for Depression, Beck Depression Inventory, or Modified Scale for Suicidal Ideation scores at discharge between groups with and without cognitive therapy. The patients receiving cognitive therapy had significantly fewer members who were treatment failures than the patients who did not receive cognitive therapy (χ2=7.5, df=1, p<0.05, d=0.66). There were no significant differences in proportions of dropouts. Hierarchical linear modeling analyses indicated no significant differences between cognitive and noncognitive treatments on scores on the Modified Hamilton Rating Scale for Depression, the Beck Depression Inventory, and the Modified Scale for Suicidal Ideation. Similarly, there were no significant differences in the proportion of patients who improved or whose illness remitted ().