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ORIGINAL ARTICLES |
Center for AIDS Prevention Studies (M.A.C., D.B.C., J.M.T., L.M.J.), Department of Medicine and Osher Center for Integrative Medicine (S.F.), University of California, San Francisco, CA.
Address correspondence and reprint requests to Margaret A. Chesney, PhD, National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, MD 20892-2182. E-mail: chesneym{at}mail.nih.gov
| ABSTRACT |
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MATERIALS AND METHODS: The authors recruited 149 self-identified gay or bisexual men who were 21 to 60 years of age, reported depressed mood, and had CD4 levels of 200 to 700 cells/mm3. CET and HIV-Info participants attended 10 90-minute group sessions during the 3-month intervention phase and six maintenance sessions over the remainder of the year. Participants were assessed at baseline and at 3, 6, and 12 months. Data were collected 1992 to 1994, before the introduction of HAART. Analyses were based on the 128 participants who completed the 3-month assessment.
RESULTS: After the 3-month intervention phase, when compared with HIV-Info, CET participants showed significantly greater decreases in perceived stress and burnout, and regression analyses indicated that significant increases in coping self-efficacy mediated the improvements in perceived stress and burnout. Compared with WLC, CET participants also showed significantly greater decreases in anxiety, and regression analyses indicated that significant increases in positive states of mind mediated the improvements in anxiety. Significant treatment group differences for positive morale were maintained at 6 and 12 months. In addition, optimism continued to increase in the CET and HIV-Info treatment groups during the maintenance phase.
CONCLUSIONS: CET can be an effective strategy for managing psychological distress and improving positive psychological states in patients confronting chronic illness.
Key Words: HIV, AIDS, coping, intervention, stress.
Abbreviations: CET = coping effectiveness training;; HIV-Info = HIV informational control;; WLC = waiting-list control;; MSM = men who have sex with men;; HAART = highly active antiretroviral treatment;; CES-D = Center for Epidemiologic Studies-Depression Scale;; SCID-NP-HIV = Structured Clinical Interview for Diagnostic Statistical Manual-III-Revised: Nonpatient Version for HIV Studies;; STAI = State-Trait Anxiety Inventory;; LOT-R = Life Orientation Test-Revised;; ANOVA = analysis of variance;; ANCOVA = analysis of covariance.
| INTRODUCTION |
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The ability to cope successfully with a chronic illness such as HIV disease is influenced by a number of social and psychological factors. Stress and coping theory (6) provides a framework for studying these factors and for intervention. In addition, new developments in coping research draw attention to the co-occurrence of positive and negative psychological states and recognize the importance of encouraging coping processes that help to sustain positive psychological states in the context of stress (7, 8).
Coping, according to this theory, is a complex process that involves behavioral and cognitive responses to manage specific demands that are appraised as stressful. Coping involves both problem-focused coping (ie, strategies that focus on changing problematic aspects of stressful situations) and emotion-focused coping (ie, strategies that focus on managing emotional responses to stressful situations). The choice of coping responses is influenced by the extent to which the person appraises the situation as changeable or controllable, as opposed to unchanging or uncontrollable, and the extent to which a person selects coping strategies that are appropriate in the specific stressful situation. According to CET theory, adaptive coping occurs when there is a "fit" between the choice of coping strategy (problem-focused vs. emotion-focused) and the "changeability" of the stressful situation. Maladaptive coping occurs when people respond to changeable stressors with emotion-focused coping strategies or when people respond to unchangeable stressors with problem-focused coping strategies (9,10). When there is a poor fit, people experience more psychological symptoms than when there is a better fit (11).
HIV disease provides an appropriate test of coping theory in that some HIV-related stressors are changeable and some are unchangeable. Based on coping theory, we hypothesized that an intervention that taught adaptive coping to people with HIV disease would lead to decreases in distress. Further, recent research found that some men with AIDS, when confronted with the stress of caregiving and bereavement, showed that in addition to intense negative psychological states, they were capable of experiencing positive psychological states (7). Considering this, we hypothesized that an effective coping intervention would also lead to increases in positive states.
An extensive research literature exists on the application of cognitive behavioral therapy to both physical and mental health problems including arthritis, schizophrenia, Alzheimers disease, substance dependence, sleep disorders, and social phobia. For example, a recent study of a brief cognitive behavioral intervention for women with rheumatoid arthritis reported significant improvements for participants in psychological, physical, and coping outcomes, and noted that reviews of the literature indicate the general efficacy of cognitive behavioral interventions in this context (12).
Cognitive-behavioral stress management interventions have also been successful in decreasing psychological distress and depressed mood in HIV-seropositive gay men (1317). While important and provocative, these intervention studies for gay men had small sample sizes, did not include a comparison condition to control for group participation, and reported only immediate preintervention to postintervention effects. Although some studies indicated follow-up beyond immediate postintervention, none reported results from any assessments conducted.
Chambless and Hollon (1998) proposed the following criteria for determining efficacy in behavioral interventions: (1) treatment provided in a randomized clinical trial; (2) a comparison with other rival interventions as well as a no-treatment condition; (3) a sample size that provides adequate statistical powerapproximately 50 participants per condition; and (4) sufficient follow-up for conclusive assessment of the interventiona minimum of 6 months follow-up (18). The present study, conducted in a sample of gay men living with HIV disease, was a randomized clinical trial designed to compare the effects of a group coping intervention with two control conditions. The control conditions consisted of a group informational control and a waiting-list control. We followed the sample for 9 months postintervention to evaluate immediate and longer-term effects on outcome variables, including psychological distress and positive mood states. In addition, we investigated potential mediating mechanisms by which the intervention influenced the outcomes of psychological distress and well-being. Although previous work has shown that coping mediates psychological well-being (17), we examined this issue in a larger, controlled study with a number of positive outcome variables.
| MATERIALS AND METHODS |
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The data for this trial were collected from 1992 through 1994. Thus, no participants were using highly active antiretroviral treatment (HAART), providing a unique opportunity for us to examine the effect of the intervention in a sample of HIV patients who were confronting the stress of a condition that was, at that time, untreatable and terminal. Indeed, there was a concern that participants with advanced disease might not survive the length of the study and follow-up. Therefore, CD4 level criteria were chosen to increase the likelihood that the participants were experiencing some limitations on their lifestyles because of HIV but would survive the entire length of the trial. Potential participants who met these eligibility criteria and wished to enroll in the study were then scheduled for a face-to-face interview with a trained clinical interviewer.
Interviewers described the studys goals and procedures, answered questions, and obtained written informed consent. Potential participants were then screened for depressed mood as indicated by a score of 10 or higher on the Center for Epidemiologic Studies-Depression Scale (CES-D) (19). Interviewers also administered an abbreviated version of the Structured Clinical Interview for DSM-III-R: Nonpatient Version for HIV Studies (SCID-NP-HIV) (20). To minimize confounding circumstances, we excluded individuals who were experiencing major depressive disorder or other psychotic disorders, had a history of alcohol dependence or substance use disorder in the past year, were currently in psychotherapy, or were using therapeutic doses of psychoactive medication on a regular basis.
In a final screening step, potential participants completed two separate blood draws to verify absolute CD4 T-cell count. The two laboratory values were averaged to obtain a final CD4 criterion value. Participants who met eligibility criteria were then scheduled for a baseline psychosocial assessment and randomization.
Procedures
Of the 165 individuals who met entry criteria, 149 (90%) entered the study. The primary reasons for not enrolling in the study were scheduling difficulties, no response to follow-up contacts, moving from the San Francisco Bay Area, and declining health. Participants were randomized to one of three conditions: (1) the Coping Effectiveness Training intervention (CET, N= 54); (2) an HIV-Informational Control (HIV-Info, N= 51), designed to control for the social support of simply participating in a group; and (3) a Waiting List Control (WLC, N= 44), designed to control for the effects of assessment. Slightly larger numbers of participants were randomized to the two group-based conditions to guarantee sufficient numbers of participants assigned to treatment groups. Individuals assigned to CET and HIV-Info participated in 10 90-minute group sessions comprising 8 to 10 men and conducted by male and female co-leaders with graduate experience in social work and clinical psychology or community-based HIV services. After the initial 10-week intervention phase, the CET and HIV-Info groups met for three monthly and then three bimonthly booster sessions. During this maintenance phase, the WLC participants were crossed over to receive the CET intervention. Participants freely volunteered their time for the study and were not reimbursed.
Throughout the intervention phase, 128 (86%) of the 149 participants in the three treatment groups were retained. There were no treatment group differences in the rate of retention during this phase (p> 0.50). For those retained, however, the median percentage of intervention phase sessions attended differed for the CET (92%) and the HIV-Info participants (77%, Mann-Whitney Z = 3.15, p= 0.002). During the maintenance phase, which involved only the CET and HIV-Info treatment groups (N= 105), 79 (75%) of the participants were retained for the 6-month assessment and 70 (67%) for the 12-month assessment. There were no treatment group differences in the rate of retention at either of these assessments (both p > 0.25). For those retained, however, the median percentage of maintenance phase sessions attended differed for the CET (67%) and the HIV-Info participants (50%, Mann-Whitney Z = 2.14, p= 0.03). The reasons given by participants who dropped out of the study included moving from the San Francisco Bay Area, scheduling difficulties, the group not meeting personal needs, caregiving for an ill partner or parent, and declining health. The analyses assessing the possible loss of treatment group equivalence caused by attrition are presented in the Results section.
Intervention and Control Groups
The CET intervention has been previously described in detail (2123). Briefly, this experimental intervention is grounded in the cognitive theory of stress and coping (6,22,24), incorporates elements of stress management interventions (25, 26) and provides a framework for choosing among coping strategies to promote adaptive coping and reduce distress. The framework converts the major tenets of stress and coping theory into a series of practical straightforward steps, and emphasizes "fitting" the coping strategy to the extent to which stressful situations can be changed. In contrast, most stress management programs provide only general instructions for the application of the skills that they teach (27). An overview of the CET and HIV-Info group session content is shown in Table 1.
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Participants randomized to the HIV-Info control groups received 10 weekly sessions of didactic information on HIV-related topics and resources, including clinical trials, general health, disability, and legal issues. They also received a workbook providing reading material, such as fact sheets, articles and resource lists, on the topics covered in the sessions. As with CET, missed sessions were made up individually, and after the intervention phase HIV-Info participants continued to meet for six maintenance sessions during the remainder of 1 year.
To minimize group leader effects, co-leaders conducted an equal number of each type of group (CET and HIV-Info). In addition, each group was co-led by a male and female, and the pairings were rotated regularly. The co-leaders received intensive training in CET based on the interventions manualized protocol, were regularly updated on issues related to HIV disease, and were supervised by both the principal investigator (MAC) and the senior co-leader. To monitor the fidelity of the treatment conditions, all group sessions were audio taped for quality control and the group co-leaders attended weekly clinical supervision meetings.
Measures
Study variables were assessed at baseline (preintervention), 3 months (postintervention), and at 6 and 12 months (follow-up visits).
Outcome Variables
Depressive symptoms were assessed with the 20-item Center for Epidemiologic Studies-Depression (CES-D) measure (19) (coefficient alpha in the current study=0.90). The CES-D scale, which includes both affective and somatic items, has been extensively tested and validated (19,2830).
Perceived stress was assessed with the 10-item form of the Perceived Stress Scale (31) (alpha = 0.89). The 10-item form of this scale allows the assessment of perceived stress without any loss of psychometric quality over the original 14-item scale (32).
Burnout was assessed with a scale developed for this study. Participants in pilot studies of CET often described their distress as being a combination of anger and emotional fatigue or exhaustion. A 16-item "burnout scale" was formed based, in large part, on items from the anger and fatigue subscales of the Profile of Mood States (33). An overall burnout score was created by summing the 5-point item ratings (0 = "not at all" to 4 = "extremely"; alpha = 0.93) The 16 items ask how often during the past month participants have been feeling worn out, resentful, annoyed, fatigued, bitter, exhausted, helpless, cynical, irritated, drained, overwhelmed, enraged, emotionally numb, angry, burned out, or furious.
Anxiety was assessed with the widely used State Form of the State-Trait Anxiety Inventory (STAI) (34). This form of the STAI is designed to assess feelings of anxiety at the time the subject completes the scale (alpha = 0.94).
Negative and positive morale were assessed with modified versions of the two subscales of the Affect Balance Scale (35). Examples of questions in the eight-item negative morale scale include asking how much one feels "very lonely or remote from other people" and "that you could not do something because you just couldnt get going" (alpha = 0.71). Questions in the eight-item positive morale scale ask how much one feels "on top of the world" and "particularly excited or interested in something" (alpha = 0.89).
Mediator Variables
Coping self-efficacy was assessed with a 26-item measure of perceived self-efficacy for coping with challenges and threats developed for this study. Participants rate on a scale from 0 ("cannot do at all") to 10 ("certain can do") the extent to which they believe they could perform behaviors important to adaptive coping, such as "sort out what can be changed, and what cannot be changed," "break an upsetting problem down into smaller parts," "look for something good in a negative situation," and "get emotional support from friends and family." An overall coping self-efficacy score was created by summing the item ratings (alpha = 0.95). The scale is available from the corresponding author.
Social support was assessed with 23 items from the Social Relationships Scale (36) modified for gay men. An overall perceived social support score was created by summing item ratings for five of the six subscales: emotional and material support, affirmation, and subjective and objective social integration (alpha = 0.94).
Optimism was assessed with the widely used 12-item Life Orientation Test-Revised (LOT-R) (37,38) (alpha = 0.87).
Positive states of mind were assessed with the six-item scale developed by Horowitz et al. (39) (alpha = 0.80).
Statistical Analysis
In preliminary analyses, treatment groups were compared on preintervention characteristics to confirm their expected comparability from random assignment on 17 variables: sociodemographics (age, ethnicity, level of education, employment status, personal income in past year), health functioning (CD4 count, AIDS diagnosis), and the key outcome and mediating measures of social support, coping self-efficacy, and psychological distress and well-being. Treatment groups were also compared at the 3-, 6-, and 12-month assessments to assess any loss of equivalence caused by attrition. Comparisons at each assessment were made using the preintervention measures of these same 17 variables, as well as with the measures of the three sociodemographic (education, employment status, income) and two health functioning variables (CD4 count, AIDS diagnosis) that were time-varying. All comparisons were conducted using analysis of variance (ANOVA) or t tests for normally distributed continuous variables, Kruskal-Wallis or Mann-Whitney tests for ordered qualitative (eg, 4-point Likert rating scales) and nonnormal continuous variables, and chi-square or Fishers exact tests for categorical variables. As reported in greater detail in the Results section, there were no significant treatment group differences on any of these comparisons, thus precluding the need to use any control variables in all subsequent analyses.
The primary analyses of interest involved separate sets of analyses for the intervention and maintenance phases using data for the 10 outcome and mediating variables. Because data collected during the intervention phase included all three treatment groups, two planned contrasts within an analysis of covariance (ANCOVA) model were conducted comparing CET with each of the two control conditions, HIV-Info and WLC, at postintervention, controlling for preintervention scores. Analyses using data collected during the maintenance phase involved only the CET and HIV-Info treatment groups and three assessment points. These analyses were conducted using a group (2) by-time (3) mixed-effects repeated measures ANCOVA, controlling for preintervention scores. WLC participants were not included in these comparisons because they were crossed over to CET treatment after their 3-month assessment, and thus no longer represented a control. We assigned all WLC participants to CET to maximize the number of participants available for future within-CET group analyses. Because the WLC participants were assessed on a different delayed schedule than the other participants, they were not included in the maintenance phase analyses.
To investigate the mediating mechanisms (eg, change in self-efficacy) by which the treatment groups affected the outcomes of psychological distress and well-being (controlling for preintervention scores), analyses were conducted using the series of regression analyses proposed by Baron and Kenny (40). Because all three treatments groups were involved in the intervention phase analyses, the mediation analyses were conducted using data collected at the preintervention and postintervention assessments for outcome and mediating variables that demonstrated significant group differences.
All analyses were conducted according to the principle of intention-to-treat: participants who did not complete treatment but continued to be assessed were analyzed according to their original treatment group assignment. Others have suggested that study outcomes also be examined among those who complete more of the intervention (41). Therefore, exploratory analyses were conducted to determine if the results from the intention-to-treat analyses differed from analyses based on only those participants who received more of the intervention (ie, "completers"), defined as attending at least 80% of the initial 10-week intervention sessions. All statistical tests were performed with a two-tailed alpha of 0.05 using the Statistical Analysis System (42).
| RESULTS |
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Intervention Phase Treatment Group Comparisons for the Outcome and Mediating Variables
The comparisons of the three treatment conditions during the intervention phase were based on the 128 participants who completed the 3-month assessment. Raw means for preintervention data, least-square means for postintervention data (adjusted for preintervention scores), standard deviations, and results of the statistical analyses are presented in Table 2.1
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Maintenance Phase Treatment Group Comparisons for the Outcome and Mediating Variables
The comparisons of the CET and HIV-Info participants during the maintenance phase were based on the 90 participants in these two groups who completed at least the 3-month assessment. As reported previously, 79 and 70, respectively, of these participants completed 6- and 12-month assessments. The selection of the most appropriate covariance structure (eg, unstructured, compound symmetric, and first-order autoregressive) for the repeated measurements was based on likelihood ratio tests and Akaikes Information Criterion (AIC). The comparisons indicated that compound symmetric provided the best fit for eight of the 10 variables and unstructured for the remaining two (social support and positive states of mind). Least-square means (adjusted for unbalanced data and preintervention scores), standard deviations, and results of the statistical analyses are presented in Table 3. 2
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The overall F tests for change over time (from month 3 to months 6 and 12) were statistically significant for optimism (F [2, 145] = 6.37, p= 0.002). Pairwise comparisons showed that, from the 3- to 6-month assessments, the level of optimism in both groups continued to increase (F [1, 145] = 6.62, p= 0.01) and then leveled off between the 6- and 12-month assessments (F [1, 145] = 0.37, p= 0.54). The nonsignificant group (p= 0.09) and group-by-time interaction (p= 0.76) indicated that the pattern of improvement in optimism was similar in the two treatment groups.
Tests of Mediating Mechanisms of the Relationship Between Intervention Group and Change in Outcome Variables (Preintervention to Postintervention)
The rationale underlying CET was that training in coping skills would improve, for example, coping efficacy, which in turn would lead to decreases in psychological distress and increases in positive psychological states. The findings provide support for this strategy. A series of regression analyses was conducted to investigate the mediating mechanisms by which the intervention affected psychological distress and well-being. The mediating (ie, change in coping self-efficacy and positive states of mind) and outcome variables (ie, perceived stress, burnout, and anxiety) that demonstrated significant treatment group differences during the intervention phase were used in the analyses. The results are reported in Table 4.
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In the regression analysis with anxiety as the outcome measure (controlling for preintervention scores), the standardized ß for the CET vs. WLC treatment group indicator variable was -0.18 (t [124] = -2.08, p< 0.05). When change in positive states of mind was added to the regression model, the effect of treatment group was reduced by one-half (ß = -0.09, t [123] = -1.27, NS), again indicating mediation.
Exploratory Intervention and Maintenance Phase Analyses for CET and HIV-Info Intervention Completers
Thirty one (of 46) CET and 21 (of 44) HIV-Info participants were classified as intervention completers by having attended at least 80% of the initial 10-week intervention phase sessions. Preliminary analyses comparing the three treatment conditions (ie, CET and HIV-Info completers and WLC participants) at all assessments indicated that there were no group differences in any of the sociodemographic and health functioning variables (all p> 0.15), or in the preintervention measures of the key outcome and mediating variables (all p > 0.10).
Results of the completers analyses using intervention phase data for the six outcome variables were similar to those of the intention-to-treat analyses. Differences were found for analyses involving three mediating variables. The significant comparisons of the (1) CET and HIV-Info groups on coping self-efficacy and the (2) CET and WLC groups on positive states of mind, were no longer significant with the completers analyses (respectively, F [1, 121] = 1.62, p= 0.20; F [1, 121] = 2.49, p= 0.11). In addition, the statistical trend for differences on social support when comparing the CET and HIV-Info groups was now significant, with CET participants reporting higher levels (F [1, 121] = 6.42, p= 0.01). In general, results of the completers analyses using maintenance phase data were the same as the intention-to-treat analyses.
| DISCUSSION |
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When CET intervention outcomes were compared with a waiting-list control condition, this trial also provides evidence for the clinical efficacy of CET in significantly decreasing anxiety and increasing positive states of mind. The data further indicate that positive states of mind mediate the larger decreases in anxiety observed in the CET condition.
There is increasing interest in examining the effects of behavioral interventions on increasing positive psychological outcomes, particularly given the evidence that positive psychological states predict survival in non-HIV-infected cohorts who were followed-up for 2 years (45) and for more than 50 years (46). There is also evidence that positive states speed recovery from acute stressors (47), and, in an HIV-infected sample, buffer the adverse effects of significant negative life events, such as the death of a partner (48). An important feature of this study was the extended maintenance phase. Two measures of positive psychological states demonstrated statistically significant results during this phase.
Treatment group differences for positive morale were maintained at 6 and 12 months. Some might argue that this is simply a reflection of the decrease in distress, as assessed on the perceived stress and burnout measures, but this finding is consistent with new developments in coping theory (8) asserting that positive psychological states can co-occur with negative psychological states.
Optimism continued to increase in both treatment groups. The lack of an untreated control during this period, however, makes it difficult to interpret this finding. One possible explanation is that there was encouraging news about new HIV treatments during this time. This was not the case, given that therapeutic advances occurred after the final follow-up assessment. Another possibility is that both the CET and HIV-Info participants benefited from the ongoing social support provided by their treatment groups, which continued to meet for booster sessions during the maintenance phase. These findings suggest that CET could be included as a component of HIV care with only occasional booster sessions to help sustain positive psychological states.
The fact that the completers analyses did not yield stronger findings may be due to various factors. These analyses included smaller samples sizes in the CET and HIV-Info groups. Also, some participants reported that they learned coping skills quickly, integrated them into their daily lives, and stopped attending sessions. When these participants, who perhaps were effectively coping, were not included in the "completers analysis," differences between treatment groups may have been diminished.
There are several limitations of the present study. Because physical examinations were not included in this study, it is not possible to know if the decreases in psychological distress and increases in positive psychological states were reflected in any changes in disease progression. Further, the fact that we did not observe a significant effect of CET on reducing depressive symptoms may have been because of our use of the CES-D rather than a more clinically derived assessment tool, such as the Beck Depression Inventory.
Another limitation is the number of participants who dropped out during the study. Other behavioral intervention studies with HIV-infected patients (4952) and with breast cancer patients (53) have observed similar attrition levels. The reasons for dropping out of the study included moving from the San Francisco Bay Area, scheduling difficulties, the group not meeting personal needs, caregiving for an ill partner or parent, and declining health. Taken together, these reasons suggest that we might have achieved higher retention levels if we had delivered the intervention on an individual, rather than group, basis. While some of the advantages provided by the group experience would have been lost, an individual level intervention would permit more flexibility in scheduling and greater tailoring to individual needs (54). Finally, our selection criteria resulted in a relatively homogeneous sample of gay men. This may limit generalizability to other HIV- infected populations differing in gender or stage of disease.
Coping with chronic illnesses such as HIV represents a major challenge to health care. These data indicate that patients confronting chronic illness may benefit from theory-based interventions such as CET in terms of both decreases in distress and increases in positive states. It is particularly notable that several of the positive psychological states observed in this study were sustained over a 12-month period of time, during which effective HIV therapies were not available, suggesting that these data may hold promise for others confronting untreatable conditions. The fact that this study was completed before the availability of the HAART therapies underscores the need to evaluate the efficacy of CET in a broader sample of people living with HIV, including those on HAART with its accompanying challenges of medication adherence and side effects.
| ACKNOWLEDGMENTS |
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| NOTES |
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2In addition to the treatment group comparisons based on the total 20-item CES-D score, exploratory analyses were conducted to investigate the possibility that the intervention would have a differential impact upon affective (using the 15-item CES-D subscale) and somatic (using the 5-item CES-D subscale) depressive symptoms. As with the total CES-D score, however, group comparisons during the intervention and maintenance phases using the two subscales scores were also nonsignificant (p > 0.10). ![]()
Received for publication October 9, 2002.
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