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Journal of Back and Musculoskeletal Rehabilitation 27 (2014) 563–568 DOI 10.3233/BMR-140518 IOS Press
Randomized controlled trial on the effectiveness of cognitive behavior group therapy in chronic back pain patients Michael Lindena,∗, Sieghard Scherbeb and Burkhard Cicholasb a
Research Group Psychosomatic Rehabilitation, Charité University Medicine, Berlin, Germany Department of Psychosomatic and Orthopedic Rehabilitation, Rehabilitation Center of the German Federal Pension Agency, Frankenhausen, Germany
b
Abstract. BACKGROUND: It is empirically well documented that psychotherapy is vital in the treatment of chronic back pain. OBJECTIVE: To test in this randomized controlled clinical trial whether cognitive behavior group therapy is effective in respect to pain tolerance and disability apart from the effects on somatization in general and additional to the effects of a multimodal inpatient orthopedic rehabilitation programme. METHODS: Fifty-three patients were randomly assigned to an intervention group, receiving six sessions of “cognitive behavior group therapy for back pain” (CBT-BP), and 50 to a control group who got unspecific occupational therapy sessions instead. Patients were suffering from chronic back pain for at least six months. All patients were treated for 21 days in an orthopedic inpatient rehabilitation unit with a multimodal orthopedic treatment, including active physical therapy, patient education or motivation to exercise. RESULTS: In both groups there is a significant improvement over time in the Symptom Checklist (SCL-90), the Rating of Health Locus of Control Attributions, the Fear Avoidance Beliefs Questionnaire (FABQS) and a Visual Analogue Pain Scale (VAS-pain). There are significant interactions between treatment group and VAS-pain and the FABQS, showing a superior improvement in the intervention group, while no significant superiority is found for the SCL. CONCLUSIONS: The experience of pain can be altered directly and not only through improvement of depression or general somatoform complaints. The study replicates other research and increases the evidence base for this mode of treatment. The treatment effect can be called specific as it is found additional to a multimodal inpatient care programme. Keywords: Cognitive behavior therapy, low back pain, rehabilitation, fear avoidance beliefs, pain, locus of control
1. Introduction Chronic back pain is found in about 8–10% of the general population [1,2]. The degree to which such chronic pain results in disability is depending not only from the somatic status but also, if not even more, from psychosocial factors [3–6]. This includes the under∗ Corresponding author: M. Linden, Research Group Psychosomatic Rehabilitation, Lichterfelder Allee 55, 14513 Teltow, Germany. Tel.: +49 03328/345678; Fax: +49 03328/345555; E-mail: [email protected].
standing of the illness, coping strategies in general and pain management in particular, the intensity and quality of subjective experience of pain, mental disorders, problems at work or in the family, intelligence, or social status. The treatment of back pain must therefore not only focus on medical interventions or physiotherapy but also psychosocial treatments which focus on emotional changes, changes in attitudes, improvement in coping, and activation. There are many studies which show that multimodal treatments, which include psychosocial interventions, can reduce suffering, medication intake, vis-
c 2014 – IOS Press and the authors. All rights reserved ISSN 1053-8127/14/$27.50
564
M. Linden et al. / Randomized controlled trial on the effectiveness of cognitive behavior group therapy
its to physicians, disability and can improve the long term course [7–20]. Jäkle and Basler [21] showed in a metaanalysis on prospective, randomized, controlled studies that cognitive behavioral treatment can reduce chronic pain by modification of dysfunctional cognitions. This was preferably true for head ache but not so much for back pain. In back pain patients treatment effects were preferably mediated by changes in depression while no direct change in pain intensity was seen. A further problem is that in most cases it was difficult to show differences between specific and unspecific interventions, e.g. relaxation training and cognitive behavioral treatments [22], or cognitive-behavioral interventions with reinforcement of positive illness behavior [23]. So it can still be discussed whether there are any specific treatment effects or whether all effects are by and large unspecific and motivational. The question in this study has been whether specific cognitive behavior therapy can improve pain apart from changes in general psychosomatic complaints and additional to a general multimodal treatment programme which includes physiotherapy, medical treatment, occupational therapy, activation, and general motivation to change the life style and coping with illness.
2. Methods 2.1. Institution The study was done in the orthopedic department of the Rehabilitation Centre Frankenhausen, Germany, a unit with 95 inpatients. Patients are referred for inpatient treatment by health or pension insurance because their ability to work is endangered. 2.2. Patients Patients were suffering from back pain for at least six months according to the medical records and the assessment of the treating physicians. Patients were excluded from the study if they were at present applying for early retirement. One hundred and sixty-four patients were asked to participate in the study and 107 agreed. After randomization 3 patients withdrew their consent because they were disappointed that they were not allocated to the special treatment. One patient had for other reasons to end the inpatient stay early, so that he only participated in two sessions. He was counted as drop out. Fiftythree of the remaining 103 patients were randomly assigned to the intervention group and 50 to the control group.
2.3. Treatments All patients were treated as inpatients for 21 days undergoing a general orthopedic inpatient treatment, i.e. they were regularly seen by physicians, got medication as needed and participated on a daily basis in sport therapy and physiotherapy, balneotherapy, massages, or electrotherapy. They also got occupational therapy to support their reintegration in work. There were also general patient education sessions with information on how to understand and cope with the illness. In the intervention group patients got three group sessions per week, each 90 minutes. The “cognitive behavior group therapy for back pain” (CBT-BP) was designed in reference to the GRIP [24,25] and the pain and illness management program from Geissner at al. [26] with additional cognitive behavior therapy interventions which aim at stress reduction and problem solving, self monitoring, pain management, change in dysfunctional cognitions, reduction of avoidance behavior, and wellbeing therapy. In the first session patients were asked to report about their ways of coping with back pain, when pain is increasing and when decreasing, how pain impairs subjective wellbeing and how psychological problems increase the experience of pain. Furthermore the patients were educated on the Gate-Control-Concept [27] and how this can help to reduce the experience of pain. Patients were also given a relaxation training. In the second session patients were educated to work with a pain diary. Patients were also educated on the frequency of back pain and their medical meaning. They were furthermore trained to reduce pain by using positive imaginations [28]. In the third session patients were educated on how to incorporate correct movements in their daily activities. The psychological focus has been on the “Fear-AvoidanceModel” [29,30]. Patients collect and discuss how to change pain behavior, what works and what can be done when. The pain diary should now not only list the intensity of pain but also the context of more or less pain. The fourth and fifth session focused on dysfunctional cognitions, on attention focus and on positive experiences, following a behavioral analytic model including stimuli, cognitions, somatic reactions, behavior reactions, consequences [31]. The patients learned that cognitions can influence how situations or pain are evaluated and how cognitions can be modified, in reference to techniques from cognitive therapy [32]. The pain diary did from now on also list dysfunctional cognitions. The sixth session focused on an increase in activities. Patients were motivated to look for pleasurable
M. Linden et al. / Randomized controlled trial on the effectiveness of cognitive behavior group therapy
activities and daily duties, and to identify avoidance behavior. Patients were motivated to plan what can be done, what they want to do, and how they can motivate themselves. Patients were also educated on how to solve problems in their life (Nezu 2004). This follows general principles of behavior therapy (definition of the problem → analysis of the problem → analysis of blockades → collection of possible solutions → evaluation of solutions → selection of a solution → implementation of the solution → evaluation of outcome). Finally patients were asked to summarize what they have learned and what they will do in the future. The therapist was a physician with training in CBT. The patients in the control group got also the general orthopedic treatment as outlined above. In order to control for unspecific therapeutic attention, they got additional occupational therapy sessions where they played games and were motivated to engage in positive leisure activities. 2.4. Instruments The Fear Avoidance Beliefs Questionnaire, FABQ [29,33,34] was used to measure how much fear and avoidance patients were showing because of low back pain. The scale has 16 items, with two subscales. Subscale 1 measures “fear-avoidance beliefs about work” (e.g. My work aggravated my pain), and subscale 2 “fear-avoidance beliefs about physical activity” (e.g. Physical activity makes my pain worse). Items are rated on a 7 point Likert scale ranging from completely disagree to completely agree. The higher the scores the greater the degree of fear and avoidance beliefs. The Visual Analogue Scale Pain (VAS pain) was used to measure the subjective experience of pain intensity [35,36]. Patients mark on a bipolar ten centimeter scale whether they are at present suffering from acute and severe pain or no pain. Patients were asked to fill in this scale three times a day. The global score is the average across all ratings per patient. The Pain Disability Index, PDI [37–40], was used to assess pain-related disability and the impact that pain has on the ability of a person to participate in essential activities of live. The global score across all items ranges from 0 to 70. The higher the index the greater the person’s disability due to pain. The scale measures disability in respect to areas of life outside the hospital, i.e. family, hobbies, occupation, sex etc. In the context of this study, this scale validates the VAS-pain scale. If the ratings of pain would reflect a general positive
565
or optimistic rating bias, VAS-pain and PDI should be filled in similarly, if patients rate pain as such, changes can only be expected in the VAS-pain but not the PDI. The Symptom Checklist, SCL-90-R [41] is a selfrating questionnaire with 90 unspecific psychological and psychosomatic complaints. Patients rate the severity for each symptom on a scale from 0 (symptom not present) to 3 (very severe). The SCL global score stands for the general psychological and psychosomatic severity of mental illness. We also report the data on the subscale somatization as this is the very psychological dimension which reflects the tendency of patients to complain about somatic suffering with and without pain. For all patients sociodemographic data and work status were assessed. 2.5. Ethical committee The study has been reviewed and approved by the ethical committee of the Charité University Medicine Berlin.
3. Results 3.1. Patient characteristics The average age of patients was 50 years: 68% were female and 85% married; 20% had at least a high school or university diploma; 22% said that they were alone with only few social contacts; 85% were employed, while the others were at present not working, with 5% unemployed longer than 1 year; 35% were presently on sick leave; 41% were mostly sitting at work and 15% reported that they had to lift or carry heavy loads. There were no differences between the intervention and the control group (Table 1). 3.2. Clinical ratings Table 2 gives the data for the clinical assessment before and after treatment in comparison of intervention and control group. Over the time of treatment, significant improvements are seen for both groups in all measures with the exception of the PDI. There are significant interactions for VAS-pain and for the FABQ, including all subdimensions, indicating a superior improvement in the intervention group. There is no significant superiority of the intervention group for the PDI and the SCL global score or the SCL somatization subscore.
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M. Linden et al. / Randomized controlled trial on the effectiveness of cognitive behavior group therapy Table 1 Patient characteristics Age years (mean, sd) Female (%) Married (%) High school, university (%) Rare social contacts (%) Presently employed (%) Presently on sick leave (%) Severe loads at work (%) Sitting at work (%)
All n = 103 50,8 [6, 9] 68 85 20 22 85 35 15 41
Intervention n = 53 50,4 [6, 9] 68 83 19 19 89 34 15 40
Control n = 50 49,7 [7, 1] 68 88 12 26 82 36 14 42
Table 2 Clinical ratings before and after treatment for the intervention and the control group Variable
VAS pain pre Post PDI pre Post FABQS1 pre Post FABQS2 Pre Post FABQtotal Pre Post SCL-90-GSI Pre Post SCL-90-Somat pre Post
All N = 103 Mean (sd) 5.95 (1.5) 3.56 (2.0) 21.61 (12.1) 20.52 (13.4) 23.19 (3.1) 17.58 (7.1) 16.24 (8.2) 14.30 (8.1) 50.15 (16.8) 40.02 (20.0) 0.63 (0.2) 0.32 (0.4) 10.84 (6.8) 6.68 (6.1)
Intervention N = 53 Mean (sd) 6.04 (1.3) 3.06 (1.6) 21.43 (10.5) 19.94 (12.1) 23.09 (3.1) 13.77 (5.9) 16.79 (7.7) 13.26 (7.6) 51.21 (15.6) 34.28 (17.9) 0.63 (0.6) 0.27 (0.3) 10.08 (6.0) 5.45 (3.7)
4. Discussion The first result is that CBT-BP is effective in improving (a) pain experience, and (b) coping and attitudes in respect to back pain. The VAS-pain shows a significantly better improvement in the intervention than in the control group. Patients initially start with similar scores of moderate to severe pain (5.86 control; 6.04 intervention) and report low scores in the intervention group (3.06) and moderate scores in the control group (4.1) after treatment. The data suggest that CBT-BP can reduce pain perception in back pain patients. CBT-BP also improves fear of pain and avoidance behavior, as measured with the FABQ. Fear and avoidance are important links in the development of chronic pain, as they result in relieving posture and inactivity, which then leads to further atrophy of muscles and finally chronic false posture and again in more pain. The treatment of anxiety and avoidance behavior is a domain of CBT in general and respective interventions also seem to work in hypochondriac anxieties, anxieties related to somatic illness or pathological realangst [42].
Control N = 50 MW 5.86 (1.8) 4.10 (2.2) 21.80 (13.7) 21.14 (14.8) 23.30 (3.2) 21.62 (5.9) 15.66 (8.9) 15.40 (8.5) 49.02 (18.0) 46.10 (20.3) 0.64 (0.5) 0.36 (0.4) 11.66 (7.4) 7.98 (7.6)
Analysis of variance P Pre/post Interaction 0.000 0.002 0.123
0.549
0.000
0.000
0.000
0.002
0.000
0.000
0.000
0.288
0.000
0.343
Both results get credibility and validity as patients did not rate any changes in the PDI, which asks for changes in their daily life at home while they are in inpatient treatment, so that this rating can only reflect past memories which must stay the same during the inpatient stay. Of importance is that there is no significant treatment related improvement in the SCL-90-R. Patients were not patients with mental disorders but with orthopedic disorders. The initial scores of the SCL-90GSI are comparatively low. There is some improvement during treatment which can be explained by effects of the inpatient stay as such, with relief from daily duties, change of environment and other relaxing activities, as the SCL-90-R contains items like sleep and fatigue, or general well being. This should improve during an inpatient rehabilitation stay without any specific intervention. But, there is no additional benefit through CBT-BP. This suggests that the treatment effect is not due to an unspecific improvement in depression or somatization, which is also supported by the additional analyses in respect to the subscale “somatization” of the SCL-90.
M. Linden et al. / Randomized controlled trial on the effectiveness of cognitive behavior group therapy
Limitations of the study are that such psychotherapy studies can not be done blinded, inspite of the control group. Patients of the intervention group know what therapists expect from them and this could also show up in the ratings. The intervention and the inpatient stay have been short and no data are available on the further course.
5. Conclusions (a) The study results are in line with the existing scientific literature and add evidence to the recommendation, that CBT-BP should be part of the treatment of chronic back pain. (b) The data suggest, that cognitive therapy can reduce back pain and increase functional coping, and that this is not mediated by an improvement in mental health and a reduction of depression, anxiety or somatization in general or by induction of some general optimistic views. Pain is not identical with mental problems. (c) The study shows that CBT-BP is a specific intervention which leads to changes beyond what can be achieved by general orthopedic rehabilitation, i.e. additional to medical treatment, physiotherapy, sport therapy, and patient education. CBT-BP should therefore be a treatment mode in such rehabilitation programs.
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Journal of Back and Musculoskeletal Rehabilitation 27 (2014) 563–568 DOI 10.3233/BMR-140518 IOS Press
Randomized controlled trial on the effectiveness of cognitive behavior group therapy in chronic back pain patients Michael Lindena,∗, Sieghard Scherbeb and Burkhard Cicholasb a
Research Group Psychosomatic Rehabilitation, Charité University Medicine, Berlin, Germany Department of Psychosomatic and Orthopedic Rehabilitation, Rehabilitation Center of the German Federal Pension Agency, Frankenhausen, Germany
b
Abstract. BACKGROUND: It is empirically well documented that psychotherapy is vital in the treatment of chronic back pain. OBJECTIVE: To test in this randomized controlled clinical trial whether cognitive behavior group therapy is effective in respect to pain tolerance and disability apart from the effects on somatization in general and additional to the effects of a multimodal inpatient orthopedic rehabilitation programme. METHODS: Fifty-three patients were randomly assigned to an intervention group, receiving six sessions of “cognitive behavior group therapy for back pain” (CBT-BP), and 50 to a control group who got unspecific occupational therapy sessions instead. Patients were suffering from chronic back pain for at least six months. All patients were treated for 21 days in an orthopedic inpatient rehabilitation unit with a multimodal orthopedic treatment, including active physical therapy, patient education or motivation to exercise. RESULTS: In both groups there is a significant improvement over time in the Symptom Checklist (SCL-90), the Rating of Health Locus of Control Attributions, the Fear Avoidance Beliefs Questionnaire (FABQS) and a Visual Analogue Pain Scale (VAS-pain). There are significant interactions between treatment group and VAS-pain and the FABQS, showing a superior improvement in the intervention group, while no significant superiority is found for the SCL. CONCLUSIONS: The experience of pain can be altered directly and not only through improvement of depression or general somatoform complaints. The study replicates other research and increases the evidence base for this mode of treatment. The treatment effect can be called specific as it is found additional to a multimodal inpatient care programme. Keywords: Cognitive behavior therapy, low back pain, rehabilitation, fear avoidance beliefs, pain, locus of control
1. Introduction Chronic back pain is found in about 8–10% of the general population [1,2]. The degree to which such chronic pain results in disability is depending not only from the somatic status but also, if not even more, from psychosocial factors [3–6]. This includes the under∗ Corresponding author: M. Linden, Research Group Psychosomatic Rehabilitation, Lichterfelder Allee 55, 14513 Teltow, Germany. Tel.: +49 03328/345678; Fax: +49 03328/345555; E-mail: [email protected].
standing of the illness, coping strategies in general and pain management in particular, the intensity and quality of subjective experience of pain, mental disorders, problems at work or in the family, intelligence, or social status. The treatment of back pain must therefore not only focus on medical interventions or physiotherapy but also psychosocial treatments which focus on emotional changes, changes in attitudes, improvement in coping, and activation. There are many studies which show that multimodal treatments, which include psychosocial interventions, can reduce suffering, medication intake, vis-
c 2014 – IOS Press and the authors. All rights reserved ISSN 1053-8127/14/$27.50
564
M. Linden et al. / Randomized controlled trial on the effectiveness of cognitive behavior group therapy
its to physicians, disability and can improve the long term course [7–20]. Jäkle and Basler [21] showed in a metaanalysis on prospective, randomized, controlled studies that cognitive behavioral treatment can reduce chronic pain by modification of dysfunctional cognitions. This was preferably true for head ache but not so much for back pain. In back pain patients treatment effects were preferably mediated by changes in depression while no direct change in pain intensity was seen. A further problem is that in most cases it was difficult to show differences between specific and unspecific interventions, e.g. relaxation training and cognitive behavioral treatments [22], or cognitive-behavioral interventions with reinforcement of positive illness behavior [23]. So it can still be discussed whether there are any specific treatment effects or whether all effects are by and large unspecific and motivational. The question in this study has been whether specific cognitive behavior therapy can improve pain apart from changes in general psychosomatic complaints and additional to a general multimodal treatment programme which includes physiotherapy, medical treatment, occupational therapy, activation, and general motivation to change the life style and coping with illness.
2. Methods 2.1. Institution The study was done in the orthopedic department of the Rehabilitation Centre Frankenhausen, Germany, a unit with 95 inpatients. Patients are referred for inpatient treatment by health or pension insurance because their ability to work is endangered. 2.2. Patients Patients were suffering from back pain for at least six months according to the medical records and the assessment of the treating physicians. Patients were excluded from the study if they were at present applying for early retirement. One hundred and sixty-four patients were asked to participate in the study and 107 agreed. After randomization 3 patients withdrew their consent because they were disappointed that they were not allocated to the special treatment. One patient had for other reasons to end the inpatient stay early, so that he only participated in two sessions. He was counted as drop out. Fiftythree of the remaining 103 patients were randomly assigned to the intervention group and 50 to the control group.
2.3. Treatments All patients were treated as inpatients for 21 days undergoing a general orthopedic inpatient treatment, i.e. they were regularly seen by physicians, got medication as needed and participated on a daily basis in sport therapy and physiotherapy, balneotherapy, massages, or electrotherapy. They also got occupational therapy to support their reintegration in work. There were also general patient education sessions with information on how to understand and cope with the illness. In the intervention group patients got three group sessions per week, each 90 minutes. The “cognitive behavior group therapy for back pain” (CBT-BP) was designed in reference to the GRIP [24,25] and the pain and illness management program from Geissner at al. [26] with additional cognitive behavior therapy interventions which aim at stress reduction and problem solving, self monitoring, pain management, change in dysfunctional cognitions, reduction of avoidance behavior, and wellbeing therapy. In the first session patients were asked to report about their ways of coping with back pain, when pain is increasing and when decreasing, how pain impairs subjective wellbeing and how psychological problems increase the experience of pain. Furthermore the patients were educated on the Gate-Control-Concept [27] and how this can help to reduce the experience of pain. Patients were also given a relaxation training. In the second session patients were educated to work with a pain diary. Patients were also educated on the frequency of back pain and their medical meaning. They were furthermore trained to reduce pain by using positive imaginations [28]. In the third session patients were educated on how to incorporate correct movements in their daily activities. The psychological focus has been on the “Fear-AvoidanceModel” [29,30]. Patients collect and discuss how to change pain behavior, what works and what can be done when. The pain diary should now not only list the intensity of pain but also the context of more or less pain. The fourth and fifth session focused on dysfunctional cognitions, on attention focus and on positive experiences, following a behavioral analytic model including stimuli, cognitions, somatic reactions, behavior reactions, consequences [31]. The patients learned that cognitions can influence how situations or pain are evaluated and how cognitions can be modified, in reference to techniques from cognitive therapy [32]. The pain diary did from now on also list dysfunctional cognitions. The sixth session focused on an increase in activities. Patients were motivated to look for pleasurable
M. Linden et al. / Randomized controlled trial on the effectiveness of cognitive behavior group therapy
activities and daily duties, and to identify avoidance behavior. Patients were motivated to plan what can be done, what they want to do, and how they can motivate themselves. Patients were also educated on how to solve problems in their life (Nezu 2004). This follows general principles of behavior therapy (definition of the problem → analysis of the problem → analysis of blockades → collection of possible solutions → evaluation of solutions → selection of a solution → implementation of the solution → evaluation of outcome). Finally patients were asked to summarize what they have learned and what they will do in the future. The therapist was a physician with training in CBT. The patients in the control group got also the general orthopedic treatment as outlined above. In order to control for unspecific therapeutic attention, they got additional occupational therapy sessions where they played games and were motivated to engage in positive leisure activities. 2.4. Instruments The Fear Avoidance Beliefs Questionnaire, FABQ [29,33,34] was used to measure how much fear and avoidance patients were showing because of low back pain. The scale has 16 items, with two subscales. Subscale 1 measures “fear-avoidance beliefs about work” (e.g. My work aggravated my pain), and subscale 2 “fear-avoidance beliefs about physical activity” (e.g. Physical activity makes my pain worse). Items are rated on a 7 point Likert scale ranging from completely disagree to completely agree. The higher the scores the greater the degree of fear and avoidance beliefs. The Visual Analogue Scale Pain (VAS pain) was used to measure the subjective experience of pain intensity [35,36]. Patients mark on a bipolar ten centimeter scale whether they are at present suffering from acute and severe pain or no pain. Patients were asked to fill in this scale three times a day. The global score is the average across all ratings per patient. The Pain Disability Index, PDI [37–40], was used to assess pain-related disability and the impact that pain has on the ability of a person to participate in essential activities of live. The global score across all items ranges from 0 to 70. The higher the index the greater the person’s disability due to pain. The scale measures disability in respect to areas of life outside the hospital, i.e. family, hobbies, occupation, sex etc. In the context of this study, this scale validates the VAS-pain scale. If the ratings of pain would reflect a general positive
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or optimistic rating bias, VAS-pain and PDI should be filled in similarly, if patients rate pain as such, changes can only be expected in the VAS-pain but not the PDI. The Symptom Checklist, SCL-90-R [41] is a selfrating questionnaire with 90 unspecific psychological and psychosomatic complaints. Patients rate the severity for each symptom on a scale from 0 (symptom not present) to 3 (very severe). The SCL global score stands for the general psychological and psychosomatic severity of mental illness. We also report the data on the subscale somatization as this is the very psychological dimension which reflects the tendency of patients to complain about somatic suffering with and without pain. For all patients sociodemographic data and work status were assessed. 2.5. Ethical committee The study has been reviewed and approved by the ethical committee of the Charité University Medicine Berlin.
3. Results 3.1. Patient characteristics The average age of patients was 50 years: 68% were female and 85% married; 20% had at least a high school or university diploma; 22% said that they were alone with only few social contacts; 85% were employed, while the others were at present not working, with 5% unemployed longer than 1 year; 35% were presently on sick leave; 41% were mostly sitting at work and 15% reported that they had to lift or carry heavy loads. There were no differences between the intervention and the control group (Table 1). 3.2. Clinical ratings Table 2 gives the data for the clinical assessment before and after treatment in comparison of intervention and control group. Over the time of treatment, significant improvements are seen for both groups in all measures with the exception of the PDI. There are significant interactions for VAS-pain and for the FABQ, including all subdimensions, indicating a superior improvement in the intervention group. There is no significant superiority of the intervention group for the PDI and the SCL global score or the SCL somatization subscore.
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M. Linden et al. / Randomized controlled trial on the effectiveness of cognitive behavior group therapy Table 1 Patient characteristics Age years (mean, sd) Female (%) Married (%) High school, university (%) Rare social contacts (%) Presently employed (%) Presently on sick leave (%) Severe loads at work (%) Sitting at work (%)
All n = 103 50,8 [6, 9] 68 85 20 22 85 35 15 41
Intervention n = 53 50,4 [6, 9] 68 83 19 19 89 34 15 40
Control n = 50 49,7 [7, 1] 68 88 12 26 82 36 14 42
Table 2 Clinical ratings before and after treatment for the intervention and the control group Variable
VAS pain pre Post PDI pre Post FABQS1 pre Post FABQS2 Pre Post FABQtotal Pre Post SCL-90-GSI Pre Post SCL-90-Somat pre Post
All N = 103 Mean (sd) 5.95 (1.5) 3.56 (2.0) 21.61 (12.1) 20.52 (13.4) 23.19 (3.1) 17.58 (7.1) 16.24 (8.2) 14.30 (8.1) 50.15 (16.8) 40.02 (20.0) 0.63 (0.2) 0.32 (0.4) 10.84 (6.8) 6.68 (6.1)
Intervention N = 53 Mean (sd) 6.04 (1.3) 3.06 (1.6) 21.43 (10.5) 19.94 (12.1) 23.09 (3.1) 13.77 (5.9) 16.79 (7.7) 13.26 (7.6) 51.21 (15.6) 34.28 (17.9) 0.63 (0.6) 0.27 (0.3) 10.08 (6.0) 5.45 (3.7)
4. Discussion The first result is that CBT-BP is effective in improving (a) pain experience, and (b) coping and attitudes in respect to back pain. The VAS-pain shows a significantly better improvement in the intervention than in the control group. Patients initially start with similar scores of moderate to severe pain (5.86 control; 6.04 intervention) and report low scores in the intervention group (3.06) and moderate scores in the control group (4.1) after treatment. The data suggest that CBT-BP can reduce pain perception in back pain patients. CBT-BP also improves fear of pain and avoidance behavior, as measured with the FABQ. Fear and avoidance are important links in the development of chronic pain, as they result in relieving posture and inactivity, which then leads to further atrophy of muscles and finally chronic false posture and again in more pain. The treatment of anxiety and avoidance behavior is a domain of CBT in general and respective interventions also seem to work in hypochondriac anxieties, anxieties related to somatic illness or pathological realangst [42].
Control N = 50 MW 5.86 (1.8) 4.10 (2.2) 21.80 (13.7) 21.14 (14.8) 23.30 (3.2) 21.62 (5.9) 15.66 (8.9) 15.40 (8.5) 49.02 (18.0) 46.10 (20.3) 0.64 (0.5) 0.36 (0.4) 11.66 (7.4) 7.98 (7.6)
Analysis of variance P Pre/post Interaction 0.000 0.002 0.123
0.549
0.000
0.000
0.000
0.002
0.000
0.000
0.000
0.288
0.000
0.343
Both results get credibility and validity as patients did not rate any changes in the PDI, which asks for changes in their daily life at home while they are in inpatient treatment, so that this rating can only reflect past memories which must stay the same during the inpatient stay. Of importance is that there is no significant treatment related improvement in the SCL-90-R. Patients were not patients with mental disorders but with orthopedic disorders. The initial scores of the SCL-90GSI are comparatively low. There is some improvement during treatment which can be explained by effects of the inpatient stay as such, with relief from daily duties, change of environment and other relaxing activities, as the SCL-90-R contains items like sleep and fatigue, or general well being. This should improve during an inpatient rehabilitation stay without any specific intervention. But, there is no additional benefit through CBT-BP. This suggests that the treatment effect is not due to an unspecific improvement in depression or somatization, which is also supported by the additional analyses in respect to the subscale “somatization” of the SCL-90.
M. Linden et al. / Randomized controlled trial on the effectiveness of cognitive behavior group therapy
Limitations of the study are that such psychotherapy studies can not be done blinded, inspite of the control group. Patients of the intervention group know what therapists expect from them and this could also show up in the ratings. The intervention and the inpatient stay have been short and no data are available on the further course.
5. Conclusions (a) The study results are in line with the existing scientific literature and add evidence to the recommendation, that CBT-BP should be part of the treatment of chronic back pain. (b) The data suggest, that cognitive therapy can reduce back pain and increase functional coping, and that this is not mediated by an improvement in mental health and a reduction of depression, anxiety or somatization in general or by induction of some general optimistic views. Pain is not identical with mental problems. (c) The study shows that CBT-BP is a specific intervention which leads to changes beyond what can be achieved by general orthopedic rehabilitation, i.e. additional to medical treatment, physiotherapy, sport therapy, and patient education. CBT-BP should therefore be a treatment mode in such rehabilitation programs.
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