School of Psychology, Clinical Psychology Unit F12, University of Sydney, Australia
1 Imperial College of Science, Technology and Medicine, London, UK and
2 West Middlesex University Hospital, Isleworth, UK
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Abstract |
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Methods. Fifty-three consecutive patients with less than a 2-yr history of classic or definite RA were recruited into the trial. All participants received routine medical management during the study, and half were randomly allocated to receive an 8-week adjunctive psychological intervention. All assessments were conducted blind to the allocation. This paper reports intention-to-treat analyses of the 18-month follow-up.
Results. Consistent with short-term results, significant differences were found between the groups in depressive symptoms. The intervention group maintained improvements in joint function, although those in routine care made similar improvements over the ensuing 18 months. At follow-up, group differences emerged for disability and anxiety.
Conclusions. These results indicate that cognitive behavioural intervention offered as an adjunct to standard clinical management early in the course of RA is efficacious in producing improvements in both psychological and physical indices. Furthermore, improvements appear to increase 18 months after a brief, time-limited psychological treatment.
KEY WORDS: Arthritis, Rheumatoid, Psychological intervention, Cognitive behavioural treatment, Depression, Outcome assessment.
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Introduction |
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Despite the large number of trials that have now been reported in the literature for patients with RA [211], few have reported data on longer-term outcomes. This omission is perplexing given that for the majority of patients RA is a chronic illness with symptoms that wax and wane over time accompanied by general deterioration in physical function. Of the early outcome studies, Bradley et al. [7] found therapeutic benefits that lasted for 6 months following the intervention. Parker et al. [8] reported improvements for 12 months following treatment, but only for those participants who were highly adherent to treatment strategies. If psychological interventions are to be useful in the routine management of RA, then longer-term efficacy must be demonstrated.
Of those studies investigating intervention early in the disease process, Parker et al. [10] found that benefits were maintained at 15-month follow-up in some psychological factors and level of pain. In a 6-month follow-up, Sharpe et al. [11] found maintenance of improvements in mood, but also found an emergence of further improvements in joint function. Considerable evidence now suggests that the first 2 yr of illness represent a particular window of opportunity in the physical treatment of RA [1214]. The success of a psychological intervention within the crucial first 2 yr of illness is, as a result, particularly encouraging for the role of psychological factors in RA. However, the importance of examining the longer-term outcome is fundamental to the clinical utility of a treatment, particularly in the case of early intervention. The primary aim of early intervention is to intervene while patients remain relatively able bodied and have not yet developed unhelpful ways of managing the illness. The importance of early intervention lies in its ability to reduce the subsequent risk of either psychological and/or physical burden in the longer term. Since CBT is an intervention that expressly aims to help patients learn strategies that will improve their management of symptoms and develop more adaptive attitudes towards the illness, one might expect that the efficacy of the treatment should increase over time rather than decrease.
The aim of the present study was to examine the long-term efficacy of an adjunctive CBT programme for patients with early RA. The present study investigated whether the short-term psychological and physical benefits following a cognitive behavioural intervention (post-treatment and 6-month follow-up) were maintained or improved 18 months following treatment. It was hypothesized that improvements in depression and joint function following CBT would be maintained. It was also hypothesized that improvements which failed to reach significance following treatment, such as changes in anxiety, coping strategies and disability, would emerge as significant over the follow-up period.
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Patients and methods |
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A high recruitment rate of 89% was achieved in the trial. Sixty-three participants were identified, of whom 56 agreed to take part, although three participants later had their diagnoses changed and their data were subsequently removed from the analyses. This left 53 participants in the trial, 27 allocated to the CBT group and 26 to standard care alone. Four participants in each group dropped out during the intervention stage, leaving 23 and 22 participants at post-treatment and 6-month follow-up. Only one further participant was lost in the ensuing 12-month period from the standard care group. See Fig. 1 for the flow of participants through the trial.
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Procedure
Participants had been recruited through their routine out-patient appointments. They were instructed to complete a set of questionnaires and had medical assessments (i.e. blood tests and joint assessment) prior to intervention, following treatment and at 6- and 18-month follow-up. The present data include the results of the pre-treatment, 6- and 18-month follow-up assessments. Patients were allocated to treatment groups by simple randomization that was determined according to a standard table of random numbers. The set of random numbers was related to a list of consecutive numbers (175) and was concealed. The research nurse, who administered the assessments, gave each participant a consecutive number from 156. Participants were allocated to a condition, according to the predetermined set of random numbers, on the basis of their subject number. Participants who dropped out of the study or were later excluded were not replaced. The assessment nurse remained blind to the allocation throughout the intervention study and follow-up period. In our earlier study, the research nurse had failed to guess the allocation at a rate better than chance [11].
Outcome measures
Hospital Anxiety and Depression Scales (HADS). The HADS [16], a 14-item questionnaire, excludes somatic items of anxiety and depression and was developed to assess anxiety and depression in patients with physical health problems.
Coping Strategy Questionnaire (CSQ). The CSQ [17] is a widely used and well validated measure of coping strategies. It includes seven subscales, of which two involve maladaptive strategies. A total score of active coping is calculated by subtracting the passive scale scores from the sum of the active scale.
Self-monitored level of subjective pain. Participants were asked to record pain severity on an 11-point rating scale three times daily for 1 week. Each day was divided into three periods for which the participant monitored the number of hours of pain in addition to the severity of pain symptoms upon wakening, at 4 o'clock in the afternoon and upon going to bed. A pain index score was calculated as a product of severity and duration (h) of pain for each full-day period [18].
Stanford Health Assessment Questionnaire (HAQ). The HAQ [19] assesses the level of disability associated with RA. It is a brief self-report questionnaire that is a good predictor of disease course and is sensitive to change in early RA [20, 21].
Ritchie Articular Index (RAI). The RAI [22] is a widely used measure of joint function. It was administered by a trained rheumatology nurse, blind to the allocation of participants to intervention.
Disease measures. Blood tests were conducted to provide measures of ESR and C-reactive protein (CRP). ESR was measured using Westergren's method.
Psychological intervention
Two psychologists conducted the psychological treatment from a detailed treatment manual developed for the project. The programme involved eight individual sessions, each lasting approximately 1 h, over consecutive weeks. The cognitive and behavioural intervention was developed from standard pain management approaches [23] and self-help educational material [24].
The aims of the intervention were (i) to help patients learn strategies that would be helpful in coping with the symptoms of RA and (ii) to foster an adaptive attitude towards the illness. The intervention included the following strategies: education about the illness, applied relaxation training, goal setting with an emphasis on developing an appropriate balance between rest and exercise, attention diversion training, cognitive restructuring to help foster helpful attitudes towards illness, assertiveness training and developing plans for managing flare-ups and high-risk situations. Further details of the intervention have been published elsewhere [11, 25].
Analysis
Repeated measures 2x3 multivariate analyses of variance were conducted using SPSS 9.0 for Windows, to assess treatment effects from pre-treatment and 6- and 18-month follow-up. The analyses conducted used an intention-to-treat analysis, using the last-observation-carried-forward method. A level of significance of P < 0.05 (one-tailed tests) was accepted as the level of significance for the trial. Results of changes between pre- and post-treatment and 6-month follow-up have been presented elsewhere [11]. Means of pre-treatment and 6- and 18-month follow-up are presented in Table 1.
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The results on the HAQ were also re-analysed according to the degree of improvement shown by patients over time between pre-treatment and 18-month follow-up. The following categories were determined: (i) worsea deterioration in function of greater than 25%; (ii) unchangeda score within 25% of the original score in either direction; (iii) (somewhat) improvedan improvement in HAQ scores of between 25 and 49%; and (iv) much improvedan improvement of 50% or greater on original HAQ scores. This method was used to calculate clinically significant changes in an earlier publication and ensures that measurement error can not be interpreted as responsible for observed changes [11]. 2-test was used to determine differences in rates of improvement between the two groups.
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Results |
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Treatment effectsstatistical changes
Between the initial, 6- and 18-month follow-up assessments, the CBT group became less depressed, while the opposite was true of the standard group (groupxtime interaction: F(2, 51)=5.357; P=0.012). This represented a large effect size of 0.5 for treatment-related changes in depression. There were no significant changes in disability between pre-treatment and 6-month follow-up, but there was an interaction between treatment group and time at 18-month follow-up, indicating that the two groups had different outcomes with regard to disability (groupxtime interaction: F(2, 51)=3.730; P=0.030). This indicated a large effect size of 0.45 for treatment-related changes in disability. Similarly, changes in anxiety had failed to reach significance at the 6-month follow-up, but a treatment effect was observed on anxiety at the 18-month follow-up (groupxtime interaction: F(2, 51)=4.378; P=0.02). The effect size for treatment-related changes in anxiety was also large (ES=0.44). There were no significant differences between groups for pain level (groupxtime interaction: F(2, 51)=2.577; P=0.115) or coping strategies (groupxtime interaction: F(2, 51)=0.067; P=0.40).
No significant differences were observed for either ESR level (groupxtime interaction: F(2, 51)=1.274; P=0.264) or CRP level (groupxtime interaction: F(2, 51)=0.90; P > 0.40). Over the three assessments, both the CBT group and the standard group demonstrated comparable changes in RAI level (main effect for time: F(2, 51)=5.181; P=0.01) and there was no difference between the groups at follow-up (groupxtime interaction F(2, 51)=0.385; P > 0.4)
Treatment effectsclinical significance
In the 6-month follow-up [11], the base rate of possible depression had more than halved in the CBT group from 17% at pre-treatment to 4% at 6-month follow-up. In contrast, the proportion of cases in the possible depression range doubled from 14 to 31% [11]. At 18-month follow-up, the proportion of the sample in the standard care group with possible depression remained relatively stable at 33%, with 19% of the standard care group scoring above the cut-off point for probable depression. In the CBT group, only 13% scored as possible cases of depression with only one participant (4%) remaining in the probable range. All participants who scored in the clinical range for depression over the course of the trial had been in the clinical range at pre-treatment. There were no new cases of clinical disorder, according to the HADS, in the treatment group (see Fig. 2).
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Discussion |
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Despite this careful attention to the study design and methodology, it also had limitations which must be considered when interpreting the results. The sample size, though sufficient to detect large and clinically significant effects, may have obscured other effects that were small to moderate. Nonetheless, large and clinically meaningful changes identified in this trial are those of most interest in developing services for patient care. Although the groups were not ideally matched, statistically significant differences between groups were observed for CRP favouring the CBT group. Scores on CRP did not correlate with the outcomes that changed significantly and therefore are unlikely to affect results. There was also a higher proportion of clinically anxious participants in the CBT group, despite the fact that the groups were not significantly different in their mean anxiety scores. The conventional HADS cut-off scores for possible and probable anxiety have been well validated and widely used, but they were not validated in the present study and may not have been optimal, giving rise to the apparent discrepancies just described. Nevertheless, they are more useful in demonstrating the clinical importance of symptoms than the mean scores. Many of the participants had above average scores on anxiety that, however, failed to score above the cut-off for probable or possible anxiety. Over time, these participants in the routine management condition developed clinically significant levels of anxiety when untreated. Given the initial differences in the rates of clinical disorders for anxiety, these results should be interpreted with caution.
Another limitation is the lack of a control group for therapist attention. Given the time and resources available for the study, and the projected recruitment rate, introducing a third arm into the trial would have resulted in inadequate statistical power. There are, however, two important reasons why support was unlikely to produce the clinically significant and durable changes reported here. First, previous studies using attention control groups with patients with RA have failed to find extensive benefits of support-based interventions [2]. Second, in a recent prospective study of early RA, pain, attitudes and coping skills in addition to mood have been found consistently to predict depression over time [27]. CBT works specifically through changing patient's attitudes towards illness, their coping strategies and the way in which they manage pain. Hence, changes in these factors which have been shown to predict deterioration in mood are likely candidates for the mechanism of treatment change. These factors are not targeted in supportive interventions.
This study reports the 18-month follow-up of a single-blind, randomized, controlled trial of CBT for patients recently diagnosed with RA. The results partially supported the initial hypotheses. That is, for depression and joint function, gains made over treatment and 6-month follow-up [11] were maintained 12 months later, although for joint function the control group had made comparable improvements in that time. In the 12 months to the final assessment, the groups diverged significantly in anxiety and disability, with the CBT group showing significantly more favourable outcomes. However, no differences were observed for coping strategies, pain level or indices of disease activity.
For anxiety and depression, those patients who did not receive the psychological intervention showed a tendency to deteriorate over time. However, CBT appeared to prevent this deterioration over time, and led to small but consistent improvements. Indeed, despite the relatively small changes in mean scores, the effect sizes were large for treatment-related differences for both depression and anxiety. Moreover, changes in anxiety and depression appeared to represent clinically meaningful changes. Patients who entered the trial who were already in the clinical range (probable or possible) for depression or anxiety largely remained in the clinical range following treatment. However, there was a shift in the patients who had CBT in category from probable to possible range in half the participants for both mood states. Importantly, in the standard care group, the rate of likely clinical disorder actually increased substantially over time. The results for anxiety should be interpreted cautiously given the initial differences in the rates of likely clinical disorder between the CBT and standard care group. However, the results for depression are extremely robust. Indeed, not one participant in the CBT group who scored in the normal range on depression prior to treatment subsequently scored in the clinical range. This was not the case for those in the standard care group, many of whom developed clinically significant depressive symptomatology in the course of the trial. These results strongly suggest that CBT prevented the development of clinically significant levels of depression for a number of participants.
These results suggest that for people with early RA who have already developed clinically important symptoms of anxiety or depression, an eight-session CBT approach may be insufficient to ameliorate these symptoms completely, but may be important in preventing the development of clinically significant levels of distress. These results would suggest that offering intervention prior to the development of clinical depression or anxiety is likely to make a clinically important contribution to preventing the development of secondary psychological problems for patients with RA.
For joint function, the CBT group maintained the observed improvements reported at 6-month follow-up, although the standard care group made additional improvements over the ensuing 12 months. At 18-month follow-up, there was no difference between the groups. This is likely to reflect the fact that RA is known to be at its most aggressive within the first 2 yr of illness and therefore one would expect a reduction in the acute inflammation after that time. However, earlier changes in joint function are likely to have a long-term impact on disability [12, 13], which is consistent with the current findings. As with the psychological factors measured, disability showed small, but reliable changes over the 18 months. For the CBT group the initially low levels of disability slightly improved, whereas the standard care group had become slightly more disabled over time. This is consistent with expected increased disability as the disease progresses. Among those who did not receive the psychological intervention, over half showed worsening disability scores at follow-up, compared with 13% of those in the CBT group (Fig. 4). These results again suggest that CBT can play a preventative role in minimizing the expected deterioration in disability over the longer term course of illness.
Despite the positive changes found in the present study, an eight-session individual intervention is expensive and present data do not allow assessment of cost-effectiveness. However, there are reasons to think that intervening early may have benefits in terms of cost to health services. The present data would suggest that without intervention a high proportion of newly diagnosed patients are at risk of developing a depressive or anxiety disorder (or both). Typically once a clinical disorder has presented, psychological interventions require longer than eight sessions. The burden of untreated depression or anxiety is considerable, not only on the patient but also on his/her use of resources. Therefore, once a clinical disorder develops, the cost to health services for treatment is likely to be substantially higher than the intervention provided in the present trial. Moreover, if the effects of intervention on disability are maintained in the long term, the costs of the intervention are very likely to be offset by a reduction over the course of the disease in required health service resources. This, coupled with the benefits to participants in their quality of life, argues for increased availability of appropriate resources to manage the psychological needs of patients with RA.
Our results indicate that an intervention aimed at training patients in self-management skills, which they can subsequently use to cope with challenges imposed upon them by their illness, is likely to improve not only psychological adjustment, but also long-term physical function. It is particularly important that the benefits of CBT for mood and disability have emerged despite initially low levels of disability and mood disturbance. The trial did not target individuals who showed mood disturbance at baseline, or who were identified as particularly vulnerable, but included a group of patients representative of those with early RA. These results suggest that there would be direct clinical benefits to patients in offering routine access to psychological services early in the course of illness. Clearly, further follow-up is required to determine whether the improvements demonstrated can influence the longer-term course of this chronic illness.
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Acknowledgments |
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Notes |
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References |
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