A randomized controlled trial of cognitive behavior therapy, relaxation training, and routine clinical care for the irritable bowel syndrome. Two controlled evaluations of multicomponent psychological treatment of irritable bowel syndrome. The combination of medical treatment plus multicomponent behavioral therapy is superior to medical treatment alone in the therapy of irritable bowel syndrome. Behavioural psychotherapy in the treatment of irritable bowel syndrome. A controlled evaluation of group cognitive therapy in the treatment of irritable bowel syndrome. A controlled trial of psychological treatment for the irritable bowel syndrome. Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. Gut-directed hypnotherapy for irritable bowel syndrome: piloting a primary care-based randomised controlled trial. The treatment of irritable bowel syndrome with hypnotherapy. Evaluation of a psychological treatment for inflammatory bowel disease. Cognitive-behavioral and response-prevention treatments for bulimia nervosa. Cognitive behavioral therapy guided self-help and orlistat for the treatment of binge eating disorder: a randomized, double-blind, placebo-controlled trial. A controlled comparison of cognitive therapy and self-help support groups in the treatment of irritable bowel syndrome. Cognitive therapy for irritable bowel syndrome. A randomized controlled trial of fluoxetine and cognitive behavioral therapy for bulimia nervosa: short-term outcome. Medication and psychotherapy in the treatment of bulimia nervosa. Cognitive therapy, nutritional therapy and their combination in the treatment of bulimia nervosa. Evaluation of a psychoeducational intervention for adolescents with inflammatory bowel disease.
Psychological treatments are considered to be useful in the irritable bowel syndrome (IBS), although the evidence is based on small, often flawed trials. Although cognitive behavior therapy (CBT) and relaxation therapy have both been promising, we hypothesized that CBT would be superior to relaxation and standard care alone in IBS patients. The objective of this study was to test this assumption by comparing the effects of cognitive behavior therapy with relaxation therapy and routine clinical care alone in individuals with IBS.
                Patients (n = 105) with Rome I criteria for IBS were recruited from advertisement (n = 51) and outpatient clinics (n = 54); those patients with resistant IBS were not included. A randomized controlled trial with three arms (standard care for all groups plus either CBT or relaxation) for 8 wk was conducted, which applied blinded outcome assessments using validated measures with 1 yr of follow-up. The primary outcome for this study was bowel symptom severity.
                Of 105 patients at the commencement of treatment, the mean bowel symptom frequency score for the whole sample was 21.1 and at the end of treatment had fallen to 18.1; this persisted at the 52-wk follow-up, with a significant linear trend for scores to change over time (F = 39.57 p < 0.001). However, there were no significant differences among the three treatment conditions. Significant changes over time were found for physical functioning (F = 4.37, p < 0.001), pain (F = 3.12, p < 0.05), general health (F = 2.71, p < 0.05), vitality (F = 2.94, p < 0.05), and the social functioning scales on the Medical Outcomes Study Short Form 36 (F = 4.08, p < 0.05); however, all three arms showed similar improvement. There were significant reductions in anxiety, depression, and locus of control scales, but no significant differences among the treatment groups were detected.
                Cognitive behavior and relaxation therapy seem not to be superior to standard care alone in IBS. We report two controlled comparisons of a previously validated multicomponent (relaxation, thermal biofeedback, and cognitive therapy) treatment for irritable bowel syndrome (IBS) to an ostensible attention-placebo control (pseudo-meditation and EEG alpha suppression biofeedback) and to a symptom-monitoring control. In Study 1 (n = 10 per condition) there were nonsignificant trends for the multicomponent treatment to be superior to the attention-placebo condition. In Study 2 (n = 30 per condition), we found no advantage for the multicomponent treatment over the attention-placebo condition. Subjects in both treatment conditions showed significant reductions in GI symptoms, as measured by daily symptom diaries, and significant reductions in trait anxiety and depression. The GI symptom reductions held up over a 6 month follow-up. Possible explanations for the results are explored. Although the standard treatments for the irritable bowel syndrome (IBS) are medical, growing evidence indicates the substantial therapeutic value of psychological therapy. However, it has not been investigated whether the combination of multicomponent behavioral therapy plus medical treatment is more effective than medical treatment alone. The aim of this study was to investigate this question in patients consulting a tertiary gastrointestinal (GI) referral center.
                Twenty-four IBS outpatients were randomly assigned to the combination of standardized multicomponent behavioral therapy plus standard medical treatment (SMBT) or standard medical treatment alone (SMT). SMBT included IBS information and education, progressive muscle relaxation, training in illness-related cognitive coping strategies, problem-solving, and assertiveness training in 10 sessions over 10 wk. SMT included standardized symptom-oriented medical treatment and regular visits to a gastroenterologist every second week. Posttreatment outcome measures consisted of quantification of GI, vegetative, and psychological symptoms by means of daily symptom diaries and the assessment of changes in rectovisceral perception thresholds, as well as of questionnaire measures on psychological distress, overall well-being, illness-related coping abilities, and quality of life. Follow-ups were conducted at 3- and 6-month intervals.
                Pre- and posttreatment evaluations showed significantly (p < 0.01) greater IBS symptom reduction as measured by daily symptom diaries for the SMBT group than for the SMT group. Rectovisceral perception remained unchanged by either treatment. Overall well-being significantly improved in the SMBT group but remained unchanged in the SMT group. Subjects in the SMBT group, unlike those in the SMT group, felt significantly more in control of their health, and quality of life was significantly improved in the SMBT group but remained unchanged in the SMT group.
                The data provide evidence that the combination of medical treatment plus multicomponent behavioral treatment is superior to medical treatment alone in the therapy of IBS. The irritable bowel syndrome is a highly prevalent condition whose underlying aetiology is not understood. While many patients respond to a combination of gastrointestinal antispasmodics, bulking agents and dietary manipulation, controlled clinical trials have suggested that the benefit is only marginal and is due mainly to the large placebo effect found in this condition, which has been calculated to range between 54 and 81%. Associations between the syndrome and psychological and social stresses suggest, however, that treatment involving a systematic approach to the management of symptoms may hold out real therapeutic possibilities. In the current study, 42 IBS patients were randomly allocated to either medical treatment or to behavioural psychotherapy with a nurse therapist. They were assessed initially and at 4 and 9 months. There was a general improvement over the 9 months on a number of physical and psychological symptoms measured. However, no differences were found between treatment groups except for changes in two avoidance scores. A significant correlation was found, however, between improvement in the bowel symptoms of IBS (stomach pain and diarrhoea) and improvement in the psychological symptoms measured by the Clinical Interview Schedule, suggesting a close interrelationship between the two. We randomized, at two sites, 210 patients with Rome II diagnosed irritable bowel syndrome (IBS), of at least moderate severity, to one of three conditions: group-based cognitive therapy (CT; n=120), psychoeducational support groups (n=46) as an active control, or intensive symptom and daily stress monitoring (n=44). One hundred eighty-eight participants completed the initial treatment. Those in symptom monitoring were then crossed over to CT. For an intent to treat analysis on a composite GI symptom measure derived from daily symptom diaries, both CT and the psychoeducational support groups were significantly more improved than those in the intensive symptom monitoring condition, but the CT and psychoeducational support group did not differ. Among treatment completers on the same composite measure of GI symptoms, again, both CT and psychoeducational support groups were statistically superior to symptom monitoring but did not differ on the symptom composite, or on any other measure. On individual IBS symptoms, both CT and psychoeducational support were statistically superior to symptom monitoring on reductions in abdominal pain and tenderness and for flatulence. Patient global ratings at the end of treatment showed the two active conditions statistically superior to symptom monitoring on change in Bowel Regularity, with CT superior to symptom monitoring on reduction in overall pain and in improvement in sense of well-being. Three-month follow-up data on 175 patients revealed maintenance of significant improvement or continued significant improvement on all IBS symptoms, including the McGill Pain Questionnaire. Group CT and psychoeducational support groups continued not to differ on any measure. We thus conclude that group CT is not superior to an attention placebo control condition. One hundred two patients with irritable bowel syndrome were studied in a controlled trial of psychological treatment involving psychotherapy, relaxation, and standard medical treatment compared with standard medical treatment alone. Patients were only selected if their symptoms had not improved with standard medical treatment over the previous 6 months. At 3 months, the treatment group showed significantly greater improvement than the controls on both gastroenterologists' and patients' ratings of diarrhea and abdominal pain, but constipation changed little. Good prognostic factors included overt psychiatric symptoms and intermittent pain exacerbated by stress, whereas those with constant abdominal pain were helped little by this treatment. This study has demonstrated that psychological treatment is feasible and effective in two thirds of those patients with irritable bowel syndrome who do not respond to standard medical treatment. Studies of antidepressants and psychological treatments in functional bowel disorders (FBD) are methodologically limited. The aim of this study was to assess the clinical efficacy and safety of cognitive-behavioral therapy (CBT) against education (EDU) and desipramine (DES) against placebo (PLA) in female patients with moderate to severe FBD (irritable bowel syndrome, functional abdominal pain, painful constipation, and unspecified FBD). We also evaluated the amenability of clinically meaningful subgroups to these treatments.
                This randomized, comparator-controlled, multicenter trial enrolled 431 adults from the University of North Carolina and the University of Toronto with moderate to severe symptoms of FBD. Participants received psychological (CBT vs. EDU) or antidepressant (DES vs. PLA) treatment for 12 weeks. Clinical, physiologic, and psychosocial assessments were performed before and at the end of treatment.
                The intention-to-treat analysis showed CBT as significantly more effective than EDU (P = 0.0001; responder rate, 70% CBT vs. 37% EDU; number needed to treat [NNT ], 3.1). DES did not show significant benefit over PLA in the intention-to-treat analysis (P = 0.16; responder rate, 60% DES vs. 47% PLA; NNT, 8.1) but did show a statistically significant benefit in the per-protocol analysis (P = 0.01; responder rate, 73% DES vs. 49% PLA; NNT, 5.2), especially when participants with nondetectable blood levels of DES were excluded (P = 0.002). Improvement was best gauged by satisfaction with treatment. Subgroup analyses showed that DES was beneficial over PLA for moderate more than severe symptoms, abuse history, no depression, and diarrhea-predominant symptoms; CBT was beneficial over EDU for all subgroups except for depression.
                For female patients with moderate to severe FBD, CBT is effective and DES may be effective when taken adequately. Certain clinical subgroups are more or less amenable to these treatments. In western populations irritable bowel syndrome (IBS) affects between 10% and 30% of the population and has a significant effect on quality of life. It generates a substantial workload in both primary and secondary care and has significant cost implications. Gut-directed hypnotherapy has been demonstrated to alleviate symptoms and improve quality of life but has not been assessed outside of secondary and tertiary referral centres.
                To assess the effectiveness of gut-directed hypnotherapy as a complementary therapy in the management of IBS.
                Randomised controlled trial.
                Primary care patients aged 18-65 years inclusive, with a diagnosis of IBS of greater than 6 weeks' duration and having failed conventional management, located in South Staffordshire and North Birmingham, UK.
                Intervention patients received five sessions of hypnotherapy in addition to their usual management. Control patients received usual management alone. Data regarding symptoms and quality of life were collected at baseline and again 3, 6, and 12 months post-randomisation.
                Both groups demonstrated a significant improvement in all symptom dimensions and quality of life over 12 months. At 3 months the intervention group had significantly greater improvements in pain, diarrhoea and overall symptom scores (P<0.05). No significant differences between groups in quality of life were identified. No differences were maintained over time. Intervention patients, however, were significantly less likely to require medication, and the majority described an improvement in their condition.
                Gut-directed hypnotherapy benefits patients via symptom reduction and reduced medication usage, although the lack of significant difference between groups beyond 3 months prohibits its general introduction without additional evidence. A large trial incorporating robust economic analysis is, therefore, urgently recommended. Previous research from the United Kingdom has shown hypnotherapy to be effective in the treatment of irritable bowel syndrome (IBS). The current study provides a systematic replication of this work in the United States. Six matched pairs of IBS patients were randomly assigned to either a gut-directed hypnotherapy (n = 6) or to a symptom monitoring wait-list control condition (n = 6) in a multiple baseline across subjects design. Those assigned to the control condition were later crossed over to the treatment condition. Subjects were matched on concurrent psychiatric diagnoses, susceptibility to hypnosis, and various demographic features. On a composite measure of primary IBS symptoms, treatment was superior (p = .016) to symptom monitoring. Results from the entire treated sample (n = 11; one subject was removed from analysis) indicate that the individual symptoms of abdominal pain, constipation, and flatulence improved significantly. State and trait anxiety scores were also seen to decrease significantly. Results at the 2-month follow-up point indicated good maintenance of treatment gains. No significant correlation was found between initial susceptibility to hypnosis and treatment gain. A positive relationship was found between the incidence of psychiatric diagnosis and overall level of improvement. Inflammatory bowel disease (IBD) encompasses two related gastrointestinal-tract diseases, ulcerative colitis (UC) and Crohn's Disease (CD). This study, a randomized controlled trial, compared the effectiveness of a multi-component behavioral treatment package (n = 11), which included IBD education, progressive muscle relaxation, thermal biofeedback, and training in use of cognitive coping strategies, to the effectiveness of symptom-monitoring (n = 10) as a control condition; 8 controls subsequently completed treatment. At posttreatment, the treatment group showed mean reductions on 5 symptoms, while the symptom monitoring controls showed mean reductions on all 8 symptoms. On a measure of Total Symptomatic change, the controls showed more improvement than the treated group; the treated controls at posttreatment, showed increases on all 8 symptoms. However, treated subjects perceived themselves as coping better with IBD, as feeling less IBD-related stress, and as experiencing less depression and anxiety. It is hypothesized that inherent differences may have existed between CD and UC subjects which could have led to the differences seen in treatment responses. This study was designed to assess the additive effects of major components of cognitive-behavioral treatment for bulimia nervosa. Seventy-seven female patients with bulimia nervosa were allocated at random to one of four conditions: wait-list control, self-monitoring of caloric intake and purging behaviors, cognitive-behavioral treatment, and cognitive-behavioral treatment combined with response prevention of vomiting. In the treatment conditions, participants were seen individually for fourteen 1-hr sessions over a 4-month period. All the treatment groups showed significant improvement, whereas the wait-list control group did not. Cognitive-behavioral treatment was, however, the most successful in reducing purging and in promoting positive psychological changes. Fifty-six percent of participants in this condition ceased binge eating and purging by the end of treatment, and the frequency of purging declined by 77.2% during the same period. Of the three treatment conditions, only cognitive-behavioral treatment was superior to the wait-list control. At the 6-month follow-up, 59% of the cognitive-behavioral group were abstinent, and purging had declined by 80%. Cognitive-behavioral treatment was significantly superior to the other treatment groups at this time. Thus, the addition of response prevention of vomiting did not enhance the efficacy of cognitive-behavioral treatment, and the evidence suggests that it may have had a deleterious effect. Cognitive behavioral therapy (CBT) has efficacy for binge eating disorder (BED) but not obesity. No controlled studies have tested whether adding obesity medication to CBT facilitates weight loss. We performed a randomized, placebo-controlled study of orlistat administered with guided self-help CBT (CBTgsh).
                Fifty obese BED patients were randomly assigned to 12-week treatments of either orlistat plus CBTgsh (120 mg three times a day [t.i.d.]) or placebo plus CBTgsh and were followed in double-blind fashion for 3 months after treatment.
                Seventy-eight percent of patients completed treatments without differential dropout between orlistat+CBTgsh and placebo+CBTgsh. Intent-to-treat remission rates (zero binges for past 28 days on Eating Disorder Examination Interview) were significantly higher for orlistat+CBTgsh than placebo+CBTgsh (64% versus 36%) at posttreatment but not at 3-month follow-up (52% in both). Intent-to-treat rates for achieving 5% weight loss were significantly higher for orlistat+CBTgsh than placebo+CBTgsh at posttreatment (36% versus 8%) and 3-month follow-up (32% versus 8%). Significant and comparable improvements in eating disorder psychopathology and psychological distress occurred in both treatments.
                The addition of orlistat to CBTgsh was associated with greater weight loss than the addition of placebo to CBTgsh. Clinical improvements were generally maintained at 3-month follow-up after treatment discontinuation. Thirty-four patients with irritable bowel syndrome were randomly assigned to 1 of 3 treatment conditions: individualized cognitive treatment (CT), self-help support group (SG), or symptom-monitoring waiting-list control (WL). Each of the 3 conditions lasted approximately 8 weeks. Pre- to posttreatment analyses revealed significantly greater reductions in both individual gastrointestinal (GI) symptoms and in a composite index for GI symptom change for the CT condition than for the SG or WL conditions. When compared with the SG and WL conditions, the CT condition also showed significant improvement on psychological measures of depression and anxiety. At 3-month follow-up, the results for the CT condition were maintained and revealed further numerical improvements. Twenty patients with irritable bowel syndrome (IBS) were randomly assigned either to intensive, individualized cognitive therapy (10 sessions over 8 weeks) or to 8 weeks of daily gastrointestinal (GI) symptom monitoring. Pre- to posttreatment evaluations showed significantly (p = .005) greater GI symptom reduction for those receiving cognitive therapy than for those in symptom monitoring. At posttreatment, 80% of the cognitive therapy group showed clinically significant improvement, whereas only 10% of the monitoring group showed this. Results held up well at a 3-month follow-up. Within the cognitive therapy group, GI symptom reductions correlated significantly with increases in positive and reductions in negative automatic thoughts. This study compared and combined fluoxetine and individual cognitive behavioral therapy in the treatment of bulimia nervosa. Participants were 76 women who sought treatment at the Eating Disorders Program of the Toronto Hospital and who met DSM-III-R criteria for bulimia nervosa. Subjects were randomly assigned to receive fluoxetine alone, cognitive behavior therapy alone, or the two in combination and were treated over 16 weeks. Short-term outcome revealed that all three treatment conditions were associated with clinical improvement across a wide range of parameters. The combination of pharmacotherapy and psychotherapy was superior to pharmacotherapy alone on specific parameters and there was no statistically significant advantage to the combination over psychotherapy alone. Limitations to the study include the absence of a placebo pill group and a waiting list control group as well as a substantial dropout rate across all three treatment conditions. Two treatments for bulimia nervosa have emerged as having established efficacy: cognitive-behavioral therapy and antidepressant medication. This study sought to address 1) how the efficacy of a psychodynamically oriented supportive psychotherapy compared to that of cognitive-behavioral therapy; 2) whether a two-stage medication intervention, in which a second antidepressant (fluoxetine) was employed if the first (desipramine) was either ineffective or poorly tolerated, added to the benefit of psychological treatment; and 3) if the combination of medication and psychological treatment was superior to a course of medication alone.
                A total of 120 women with bulimia nervosa participated in a randomized, placebo-controlled trial.
                Cognitive-behavioral therapy was superior to supportive psychotherapy in reducing behavioral symptoms of bulimia nervosa (binge eating and vomiting). Patients receiving medication in combination with psychological treatment experienced greater improvement in binge eating and depression than did patients receiving placebo and psychological treatment. In addition, cognitive-behavioral therapy plus medication was superior to medication alone, but supportive psychotherapy plus medication was not.
                At present, cognitive-behavioral therapy is the psychological treatment of choice for bulimia nervosa. A two-stage medication intervention using fluoxetine adds modestly to the benefit of psychological treatment. This study compared the effectiveness of cognitive therapy (CT), nutritional therapy (NT), the combination of cognitive and nutritional therapy (CNT), against a control condition of support group (SG) in the treatment of bulimia nervosa.
                One hundred female out-patients who fulfilled DSM-III-R criteria for bulimia nervosa were randomized to the four treatment groups. NT and CT were designed to cover different areas with minimal overlap, and CNT provided all of the features of both of these treatments. The control condition was conducted in a group self-help format. Each of the treatments lasted 14 weeks.
                All three active treatments as well as SG produced significant decreases in binge/vomit episodes. Intent-to-treat analysis found CNT and CT to be significantly more effective than SG in retaining subjects in treatment and completion of study, as well as in producing greater improvements in dysfunctional attitudes and self-control. CNT was superior to SG in achieving abstinence from bulimic behaviour. NT was superior to SG only in increase of self-control. Logistic regression found that the cognitive component, whether given alone or in conjunction with NT, and higher pre-treatment self-control scores were significant predictors for both completion of study and abstinence.
                CT (either alone, or in combination with nutritional therapy) remains the treatment of choice for bulimia nervosa. A treatment escalation approach should be tested for the treatment of bulimia with the more intensive and less widely available CT (with or without nutritional counselling) offered after patients have failed the less intensive and more widely available support group treatment. Inflammatory bowel disease (IBD), comprising Crohn's disease, ulcerative colitis, and indeterminate colitis, often has its onset in adolescence. The aim of this study was to evaluate whether a psychoeducational group intervention (aiming to enhance information seeking and giving about the disease, relaxation, social competence, and positive thinking) can strengthen the coping efforts of adolescents with IBD and have a positive effect on their Health-Related Quality of Life (HRQoL).
                Adolescent IBD patients from the Emma Children's Hospital AMC and adolescent members of the Crohn and Ulcerative Colitis Association in The Netherlands, were invited to participate in The intervention study. Using reliable and valid self-report instruments the adolescent's coping styles, feelings of competence, and HRQoL were assessed before and 6-8 months after the intervention. The parents were asked to fill in the Child Behavior Check List. Linear regression analyses were performed to test whether group participation was predictive of the outcome measures while correcting for the first measurement occasion and sex.
                Forty patients responded positively to invitation to the intervention. Eighteen adolescents, however, lived too far away to attend and served as a control group. Twenty-two children were enrolled and attended in groups of four to six children in six group sessions, supervised by two psychologists. The intervention seemed to have a positive effect on: coping (predictive control, P<0.01), feelings of competence (global self-worth, P<0.05 and physical appearance, P<0.01), and HRQoL (body image, P<0.05). These results give good reason to continue this intervention study with a larger population.
Psychological interventions may be slightly superior to usual care or waiting list control conditions at the end of treatment although the clinical significance of this is debatable. Except for a single study, these therapies are not superior to placebo and the sustainability of their effect is questionable. The meta-analysis was significantly limited by issues of validity, heterogeneity, small sample size and outcome definition. Future research should adhere to current recommendations for IBS treatment trials and should focus on the long-term effects of treatment.