Skip to main content
PMC home page
NIHPA Author Manuscripts logoLink to NIHPA Author Manuscripts
. Author manuscript; available in PMC: 2011 Jul 26.
Published in final edited form as: Clin Gastroenterol Hepatol. 2010 Feb 17;8(5):426–432. doi: 10.1016/j.cgh.2010.02.007

Rapid Response to Cognitive Behavior Therapy for Irritable Bowel Syndrome

Jeffrey M Lackner 1, Gregory D Gudleski 3, Laurie Keefer 2, Susan S Krasner 4, Catherine Powell 1, Leonard A Katz 1
PMCID: PMC3144205  NIHMSID: NIHMS307826  PMID: 20170751

Abstract

Background

We sought to determine whether the therapeutic phenomenon of rapid response characterizes patients undergoing CBT for irritable bowel syndrome (IBS). If RR is operating in IBS treatment, a significant proportion of CBT treated patients should achieve a positive response early in treatment (by week 4). We also hypothesized that rapid responders (RR) would be more likely to maintain treatment gains than non rapid responders (NRR). Our secondary goal was to characterize the psychosocial profile of RRs on clinically relevant demographic and clinical variables (e.g., health status, baseline level of IBS symptom severity, distress).

Methods

71 individuals ages 18–70 years with a Rome II IBS diagnosis and symptoms of at least moderate severity were randomized to one of 2 CBT treatments: either 10 weekly, one hour sessions (Standard-CBT) or four, one hour sessions over 10 weeks (Minimal Contact-CBT). RRs were classified as patients who 1) reported adequate relief of pain; 2), adequate relief of GI symptoms and 3) a decrease in total IBSSS scores of ≥50 by week 4.

Results

30% of CBT treated patients achieved RR by week 4 of treatment. 90–95% of RRs maintained gains at immediate and 3 month follow-up. While RR reported more severe IBS symptoms at baseline, they achieved more substantial and sustained gains (e.g. IBS symptom reduction) than NRRs. Standard- and MC CBT yielded comparable RR rates even though MC CBT patients received 50% less clinic treatment by week 4.

Conclusions

Rapid response is a potentially important prognostic outcome indicator that has important implications for developing step care approaches for IBS treatment.

Keywords: rapid response, cognitive-behavioral therapy, irritable bowel syndrome, outcome research

Irritable bowel syndrome (IBS) is a common, chronic, often disabling gastrointestinal (GI) disorder best understood from the perspective of the biopsychosocial model 1. Central to this conceptualization is recognition that IBS symptoms (abdominal pain/discomfort with altered defecation) are clinical manifestations of dysregulation in the bi-directional neural connections linking the gut to the cognitive and emotional centers in the brain (i.e., brain-gut axis, 2, 3). Although alterations at any level of the brain-gut axis influence motility, visceral sensation, and intestinal secretion 4, multiple lines of evidence highlight the importance of central processes in the perception and maintenance of symptoms, particularly in more severely affected patients.

One measure of the influence of central factors on IBS comes from outcome research testing the efficacy of psychosocial therapies. These data, as summarized in a recent meta-analysis 5, suggest that psychological treatments as a whole are at least moderately effective in reducing IBS symptoms. Although there was not enough data to establish the relative superiority of any one type of psychological treatment, 14 of 17 trials in the meta analysis featured cognitive behavior therapy (CBT). The therapeutic value of CBT was echoed in a recently published New England Journal of Medicine narrative review 6 that identified CBT as one of the few empirically validated treatments for IBS.

These data are important because dietary and medical treatments designed to modulate intestinal motility and decrease visceral sensitivity have proven largely unsatisfactory for IBS. Notwithstanding impressive data supporting CBT for IBS, a sizable proportion (20–35%) of patients who undergo CBT either do not respond or do not respond well enough for symptom change to represent clinically meaningful improvement 7, 8. Identifying variables that specify for whom a treatment works or under what conditions a treatment is effective has the potential to improve clinical decision making, health care policy, and patient care. If negative prognostic indicators are identified, it may be possible to engineer protocol changes in a way that optimizes outcome for patients at highest risk for treatment failure. Specifying prognostic variables would help us move closer to answering a fundamental question that should guide all efficacy research: What treatment, by whom, is most effective for this individual 9, p. 111.

Few studies have formally examined potential modifiers (predictors, moderators, variables that alter the strength or direction of a relationship) of CBT response in IBS. The few studies that have examined predictors have focused on variables conveniently collected during baseline assessment such as demographic variables (e.g., gender), distress (depression, anxiety), and clinical characteristics (e.g. symptom severity, predominant bowel habit). These variables exert such a modest influence on outcome that “other variables …must be responsible for change in the actual GI symptoms of IBS” 8, p. 334.

There is a growing belief that treatment effects are not strictly defined by the personal characteristics patients bring to treatment but are rather shaped by factors that occur during the course of treatment10–13; one such predictor is the rapidity of treatment response. Contrary to the commonly held view that patients undergoing psychological therapies improve gradually and incrementally over time and therefore require extended treatment in order to show meaningful change 7, 14, a wealth of research over the past two decades shows that a significant proportion of patients undergoing CBT for a variety of conditions achieve rapid, substantial, and sustained symptom improvements relatively early in treatment (e.g., first four weeks). 13.

The significance of the rapid response phenomenon lies partly in its prognostic value. Rapid responders are significantly more likely to do better at the end of the acute phase of CBT and long term follow up than non rapid responders 15. Prognostic information obtained before treatment has run its course has the potential to provide clinicians guidance for determining which patients are likely to respond to treatment and when treatments are “working” or “not working” 16. Patients who quickly achieve treatment gains (e.g., IBS symptom relief) may be spared the cost and inconvenience of follow up care of marginal therapeutic value. This scenario may lead to the development of self guided treatments based on multimedia technology (e.g., web, DVD, Smartphone) and free up a dearth of trained clinicians to focus on more severely affected patients. Conversely, patients who do not respond within a set number of sessions early on could be immediately identified and triaged or “stepped up” to potentially more powerful treatment(s) (e.g. combining CBT with pharmacotherapy) rather than bearing the cost, demoralization, and frustration that comes with treatment failure to insufficient unimodal therapies. The phenomenon of rapid response is not of interest only to behavioral researchers. Once the most powerful “ingredients” of behavioral treatments are distilled, biologically oriented clinical researchers in academia and industry can harness the clinical benefit of CBT to maximize the therapeutic value of pharmacological treatments.

With the assumption that the rapid response phenomenon observed in other CBT interventions would apply to IBS, we predicted that a significant proportion (25–40%) of IBS patients undergoing CBT would achieve a positive response early in treatment (by week 4). We also predicted that early responders would be more likely to maintain their treatment gains than non rapid responders at the end of acute treatment phase and through follow up 3 months after the end of treatment. A secondary goal was to characterize the psychosocial profile of rapid responders on clinically relevant cognitive processes.

Patients and Methods

Study Design

This study is a secondary analysis of a single site, three arm randomized clinical trial pitting CBT delivered in either 4- or 10-session “doses” against a waiting list control (WLC). Both CBT versions were comparably efficacious and superior to WLC in improving IBS symptoms, reducing quality of life impairment and delivering adequate relief from both pain and bowel symptoms. Additional details about the results and design of this study (e.g., CONSORT statement) are published elsewhere 17.

Participants

Participants were 75 adults between the ages of 18 and 70 years who were diagnosed with IBS according to Rome II criteria without comorbid GI disease. Four subjects were excluded because their data was not suitable for analysis. Detailed description of eligibility criteria are found in our original report17

Treatment Conditions

CBT was delivered in 2 doses: either 10 weekly, one hour sessions (S-CBT) or four, one hour sessions over 10 weeks (MC-CBT). MC-CBT covers the same range of procedures featured in S-CBT but is largely patient administered and relies extensively on self-study materials 18. The passive control subjects were wait listed (i.e. placed on a 10-week delayed treatment wait list, during which time they monitored the severity of GI symptoms on a daily basis).

Measures

Efficacy endpoints

Participants completed 2 binary (Yes/No) adequate relief measures (Adequate of relief of pain, other IBS symptoms such as diarrhea, constipation, bloating) and the Irritable Bowel Syndrome Severity Scale19 (IBSSS). The IBSS requires the patient to evaluate on 100 point scales each of five items: severityof abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, andinterference with quality of life. All five components contribute equally to the total score, yielding a range of 0–500, in which a higher score indicates a more severe condition.

Additional Measures

Several other psychometrically validated measures were administered on the same testing schedule as the IBSSS to assess the psychosocial dimension of treatment response. Our selection of measures reflected our interest in the cognitive aspects of IBS that could potentially influence rapidity of treatment response. The 25-item IBS Management SE scale20, 21 (IBS-SE) measures patients’ confidence in their ability to control and manage IBS episodes using a 7 point Likert scale (1 = strongly disagree, 7 = strongly agree). The IBS-Specific Locus of Control Scale ( IBS-LOC, 22, 23) is a 33 item scale (5 point, 1 = strongly disagree, 5 = strongly agree) that measures patients’ beliefs that IBS symptoms are internally controlled, controlled by health care professionals, or dictated by chance, respectively. The IBS version of the Treatment Self Regulation Questionnaire 24 (TSRQ-IBS) assesses the reasons for adopting behavioral strategies to manage IBS symptoms. Patterned after previous self regulation questionnaires 25 that focus on a person’s motivation for engaging in a targeted health behavior (e.g., control of glucose level), the TSRQ-IBS focuses on motivation for learning behavioral self management strategies for IBS. The TSRQ-IBS presents 15 sentence stems (“The reason I would learn self management skills for managing IBS symptoms is”) that are followed by items that represent either autonomy-oriented (“I feel that I want to take responsibility for my own stomach problems”), control-oriented oriented (“Because I feel pressure from others to do so”), or amotivation (“I really don’t know why”) motivation. Each reason is rated on a 5 point scale ranging from not true at all to very true. The Irritable Bowel Quality of Life (IBS-QOL, 26) is a 34-item disease-specific HRQOL measure assessing the subjective well-being of patients with IBS. Psychological distress was measured using the Global Severity Index (GSI) of the Brief Symptom Inventory 27. All measures were administered at baseline, at week 4 of treatment, 2 weeks after treatment ended (week 12) and at 3 month follow up with the exception of adequate relief measures that were obviously not completed at baseline.

Criteria for treatment response

Based on Rome guidelines 28 we classified treatment responders as patients who 1) provided an affirmative response to both AR questions (pain and bowel habits); and 2) demonstrated a decrease in total IBSSS score of ≥50 points from baseline. Previous research defines a reduction of ≥50 points on the IBSSS as “clinically important” 19. Patients who met these criteria for treatment responders at week four were classified as rapid responders. Patient who did not meet both of these criteria at week 12 were classified as non rapid responders (NRR).

Results

Statistical analyses

We used an intent-to-treat approach to examine the data. A last observation carried forward techniques was used to handle missing data. The technique29, 30 of replacing participant’s missing values after dropout with the last available measurement is a widely accepted strategy for dealing with missing data due to attrition in IBS clinical trials31,32, 33. One-way analyses of variance (ANOVAs) and chi-square analyses were used to assess differences between responder type on demographic and pre-treatment variables. Repeated-measures MANOVAs (RR status x time) were conducted for the IBS-LOC subscales; and the IBS-SE and TSRQ-IBS subscales. We grouped the IBS-SE and the TSRQ together because of their theoretical and statistical relationships. MANOVAs were conducted to reduce the possibility of Type II errors. If the MANOVAs were significant, post-hoc ANOVAs were conducted to explore differences between the groups on each measure at each phase of administration, and repeated measures ANOVAs examined within group differences over time, with each controlling for multiple comparisons.

Characteristics of rapid responders

Demographic characteristics and pre-treatment psychological distress of the RR and the NRR are shown in Table 1. Rapid responders did not differ significantly from non rapid responders on psychological distress or demographic characteristics (age, education level, marital status or ethnicity) with the exception of gender (females who comprised a large proportion of the sample were more likely to be RRs). Also, RR rated their pre-treatment symptoms as more severe (IBSSS: RR = 330.3 vs. NRR = 274.6, p < .01, see Table 2)

Table 1.

Baseline Characteristics of Study Sample

Rapid Responders (N = 21) Non Rapid Responders (N= 50)
Age 47.3 (17.7) 46.0 (16.2)
% Female* 100% 80%
Education
 Some High School 1 1
 High School Grad 2 4
 Some College 4 8
 College Degree 8 17
 Some Post-Grad 1 4
 Master’s Degree 5 11
 Doctoral Degree 0 5
Marital Status
 Single 5 12
 Married 8 26
 Divorced 4 10
 Widowed 2 0
 Co-habitating 2 2
Ethnicity
 Caucasian 20 47
 Asian-American 0 1
 African-American 1 1
 Hispanic 0 1
BSI
 Anxiety 57.9 (9.2) 56.6 (10.3)
 Depression 55.8 (10.8) 55.3 (9.6)
 Somatization 59.3 (7.8) 59.3 (9.7)
 Overall Distress 60.0 (8.7) 58.1 (9.3)
Open in a new tab

Note:

*

p < .05

**

p < .01

Table 2.

Rapid Responders and Non Rapid Responders Over Time on Key Clinical Variables

Pre-Treatment Post-Tx 3-Month Post-Tx
RR NRR RR NRR RR NRR
M (S.D.) M (S.D.) M (S.D.) M (S.D.) M (S.D.) M (S.D.)
IBS-LOC
 Internal 36.7 (10.6)a1 38.6 (9.8)c1 47.6 (7.5)b2 42.3 (10.4)d3 45.7 (8.4)b4 41.9 (10.5)d4
 Chance 33.4 (9.4)a1 32.2 (8.5)c1 18.8 (7.1)b2 25.2 (11.4)d3 19.1 (8.2)b2 25.8 (10.4)d3
 Health Care 26.1 (6.9)a1 29.1 (7.6)c1 22.3 (9.2)b2 25.3 (8.6)d2 20.7 (8.4)b3 25.8 (8.4)d4
IBS-SE 96.5 (25.0)a1 100.2 (25.0)c1 152.5 (18.1)b2 131.7 (33.1)d3 146.7 (19.9)b2 127.8 (32.7)d3
TSRQ-IBS
 Autonomous 39.4 (2.6)a1 35.7 (6.4)c2 39.3 (3.6)a3 37.8 (5.6)c3 39.4 (4.1)a4 37.1 (5.8)c4
 Control 14.6 (6.8)a1 13.3 (6.6)c1 16.3 (8.9)a3 13.1 (6.7)c3 15.6 (9.1)a4 13.5 (7.1)c4
 Amotivation 3.5 (1.4)a1 5.4 (3.5)c2 5.1 (3.1)b3 5.4 (3.8)c3 5.1 (3.0)b4 5.2 (3.6)c4
IBS-QOL 49.0 (21.1)a1 60.6 (17.7)c2 69.4 (16.2)b2 73.3 (17.7)c2 71.0 (17.5)b2 73.0 (18.2)c2
IBS-SSS 329.9 (63.5)a1 278.4 (79.9)c2 127.2 (58.5)b3 215.2 (96.3)d4 131.7 (66.4)b3 214.1 (97.4)d4
Open in a new tab

Note. Within group values with similar alphabetic superscripts for each measure are statistically equal. Between group values with similar numeric superscripts are statistically equal at each phase of administration. IBS-LOC = IBS Locus of Control; IBS–SE = IBS Management Self Efficacy Scale; IBS-SSS = IBS Symptom Severity Scale; TSRQ = Treatment Self Regulation Questionnaire for IBS; IBS-QOL = IBS Quality of Life

Rapid responders across the sample over time

Of the 71 patients randomized to CBT, 21 (29.6%) showed a rapid response by the fourth week of the 10 week treatment phase. Week four corresponded to clinic session 2 of treatment for patients assigned to MC-CBT and clinic session 4 for patients undergoing S-CBT. The average reduction of IBSSS total score at week 4 was 132.5 (SD = 53.0) points for rapid responders and 19.7 (SD = 69.7) points for NRR. The two CBT conditions did not differ significantly in the proportion of participants who met criteria for a rapid response at week 4. Thirty one percent of the S-CBT patients and 27% of the MC CBT patients met criteria for RR at week four.

Global IBS Symptom Relief

At week 12 (two weeks after the end of treatment), 37 out of the 71 (52.1%) participants met the criteria for treatment responder. Of the 21 RR, 19 (90.5%) were acute treatment responders. Of the 50 NRR, 18 (36.0%) were treatment responders. RRs reported significantly less symptom severity on the IBSSS than the NRR (127.2 vs. 215.2, p < .001) even though they had more severe symptoms at baseline (RR = 330.3 vs. NRR = 274.6 scores on the IBSSS). The magnitude of the difference between RRs and NRRs at post treatment well exceeded the 50 point reduction index regarded as a sign of clinical improvement34. At 3 month post-treatment follow up, 34 out of the 71 (47.9%) participants maintained their status as treatment responders as defined by the same criteria used at four week and immediate post-treatment. There was a significant differences between RR and NRR with 20/21(95.2%) of RR and 14/50 (28%) of NRR (χ2 p < .001) maintaining treatment gains at 3 months post-treatment. RR continued to report significantly less symptom severity on the IBSSS (131.7 vs. 214.1, p < .01).

Locus of Control-IBS

A repeated measures MANOVA on the IBS-LOC subscales revealed a significant interaction effect for group X time [F (6, 64) = 5.33, p < .001]. For the individual subscales of the IBS-LOC, significant interactions were found for Internal [F (2, 138) = 10.22, p < .001] and Chance [F (2, 138) = 8.50, p < .001] but not for Health Care subscales. Repeated measures ANOVAs revealed that the RR group improved significantly from pre-treatment to post-treatment and from pre-treatment to 3-month follow-up on both the Internal [pre-post: F = 32.01, p < .001; pre-3-month: F = 26.23, p, < .001] and Chance [pre-post: F 33.21=, p < .001; pre-3-month: F = 28.21, p < .001 ]subscales. There was no significant difference between the post-treatment and 3-month follow-up scores on either scale. Similar results were found for the NRR group (see Table 2).

Tests of simple effects at each assessment period revealed that there were no significant differences between the RR and NRR groups on either the Internal or Chance LOC subscales at pre-treatment. However, the RR group scored significantly better than the NRR at post-treatment on the Internal subscale [F (1, 69) = 4.32, p < .02] and the Chance subscale of the IBS LOC scale [F (1, 69) = 5.68, p < .02]. These data suggest that RR had stronger perceptions of internal control and lower perceptions that their symptoms were dictated by chance than NRR. At 3 months post-treatment, RR continued to score better than the NRR on the Chance LOC subscale [F (1, 69) = 6.69, p < .01], but the difference on the Internal LOC subscale disappeared.

IBS-Self Efficacy and Treatment Self Regulation (Motivation)

A repeated measures MANOVA on the IBS-SE and the TSRQ-IBS subscales revealed a significant interaction effect for group x time [F (8, 60) = 3.13, p < .005] with planned follow-up ANOVAs demonstrating significant interactions for the IBS-SE [F (2, 134) = 6.35, p < .005] and the Amotivation subscale of the TSRQ [F (2, 134) = 5.57, p < .005], but not for the Autonomous and Controlled subscales. Repeated measures ANOVAs revealed that the RR group improved significantly from pre-treatment to post-treatment and 3-month follow-up on both the IBS-SE [pre-post: F = 64.31, p < .001; pre-3-month: F = 57.26, p, < .001]and Amotivation [pre-post: F 4.03=, p < .01; pre-3-month: F = 5.88, p < .01 ]subscale. There were no significant differences on the Autonomous or Controlled subscales of the TSRQ, nor were there differences between the post-treatment and 3-month follow-up scores on the IBS-SE and the Amotivation subscale. For the NRR group, the only significant difference over time was from pre-treatment to post-treatment and 3-month follow-up on the IBS-SE [pre-post: F = 38.31, p < .001; pre-3-month: F = 35.06, p, < .001].

Tests of simple effects at phase of administration revealed that there were significant differences between the RR and NRR groups on the Autonomous [F (1, 67) = 6.25, p < .01] and Amotivation [F (1, 67) = 5.80, p < .01] subscales of the TSRQ at pre-treatment, with RR reporting more autonomous motivation to learn behavioral self management skills for IBS than NRR and NRR reporting a greater lack of motivation (amotivation). There were no differences between groups on the IBS-SE or the Controlled subscale at pre-treatment. Also, there were no differences between groups on any of the TSRQ subscales at post-treatment or at the 3-month follow-up. However, there were significant differences between groups on the IBS-SE at post-treatment [F (1, 69) = 7.31, p < .01] and at the 3-month follow-up [F (1, 69) = 6.00, p < .01], with the RR group reporting significantly greater self-efficacy for managing IBS symptoms.

IBS-Quality of Life

For the IBS-QOL, a repeated measures ANOVA revealed a significant interaction effect for group X time, F (2, 138) = 4.20, p < .01. Post-hoc tests showed that the RR group improved significantly from pre-treatment to post-treatment [F = 24.71, p < .001] and 3-month follow-up [F = 22.08, p < .001], with similar results for the NRR group (see Table 2). Tests of simple effects revealed that there was a significant difference between the RR and NRR groups at pre-treatment [F (1.69) = 5.71, p < .01], but this difference disappeared at both post-treatment and 3-month follow-up.

Discussion

Of 71 Rome diagnosed IBS patients randomized to CBT, 21 (29.6%) showed a rapid response by the 4th (session 4 and 2 of the S-SCT and MC-CBT, respectively) week of treatment. Rapid responders were significantly more likely than non rapid responders to meet criteria for a treatment responder at post-treatment, as outlined by the Rome II committee and to maintain this response at 3 month follow up. We are not inclined to believe the rapidity of response is simply a manifestation of a milder IBS condition. Rapid responders had more severe IBS symptoms and QOL impairment than other patients. Nor do we believe that rapid responders were less psychologically distressed than their NRR counterparts. In fact, RR did not differ from NRRS on measures of distress (BSI). Further research is necessary to clarify whether rapid responders maintain treatment response longer term (e.g. 12 month) and if, so, what propels the durability of treatment response.

Our study highlights patient and treatment factors that may promote rapid response to CBT in this population. With respect to patient factors, we found a strong connection between personal control beliefs and rapid response at interim and follow up assessment periods. In comparison with non rapid responders, rapid responders were more likely to have a high internal locus of control (i.e. attribute their symptoms to their own specific behavior ), express more confidence in their ability to make specific behavior changes necessary to control IBS symptoms and have stronger motivation to participate in a self management program.

Some might have predicted that the therapist-directed, time intensive and highly structured demands of weekly CBT would promote a more rapid response. This prediction dovetails with the dose-effect model of therapy 35 which linearly links the number of therapy sessions that clients receive to the magnitude of symptomatic improvement. In fact, a similar proportion of patients were classified as rapid responders regardless of whether they received 1 or 4 hours of face to face therapist time. This finding does not comport with the notion that “any benefit [psychologically treated IBS patients] may derive [is] from……the quantity of contact time with the provider” 36, p. S25. Conversely, others may predict that the structure and format of a brief self administered CBT program contains specific features (strict time limit, time alone, elapsed time between clinical visits) that act as “catalytic” triggers for rapid response 37. Neither of these hypotheses was verified, although, as a feasibility study, the present was not powered to detect between group differences on rate of rapid response.

Nor do our data suggest that early response is a transient placebo effect as placebo responders typically show an abrupt and early treatment response that decays over time 38. In our study, only 2 subjects “reversed” a rapid response at post-treatment. The great majority of rapid responders (92.5%) showed an enduring benefit that lasted well over 3 months with little evidence of deterioration. This suggests that rapid response is a relatively robust, clinically meaningful and enduring clinical phenomenon. Indeed, RR maintained or continued to improve on the gains made in treatment after termination

This study has important health care policy implications that extend well beyond the problem of IBS. The existing health care crisis has crystallized the importance of conducting treatment efficacy research to improve the quality of health care in the United States41. Fundamental to improving health care is conducting outcome research that asks “which treatments work best for which patients”39, 40. This has been an elusive goal in part because of the paucity of “hard data” identifying reliable predictors of outcome. In a recent study published in these pages41, we found that pre treatment clinical (e.g., predominant bowel type, abuse history, illness, duration, pain severity, psychological distress, etc) and demographic variables were for the most part poor predictors of outcome. This is not an isolated finding41. Researchers would be wise to disband a singular focus on pre treatment factors in favor of a wider one that characterizes the prognostic value of biobehavioral factors that occur during treatment if they want to best position themselves for tackling the question of which treatments works best for which patients. In this respect, this study introduces an innovative conceptual approach that has important implications for tackling some pressing health outcome questions facing us. As clinical researchers, we find gratifying increased attention paid to the importance of treatment efficacy research. As consumers of medical outcome research, we would be more confident that a large federal investment in clinical research will achieve its ambitious goals if it moves beyond solely answering “horse race questions” of whether treatment X works better than Y to more complex and nuanced questions that bear directly on improving treatment efficacy and efficiency. This answer is not necessarily revealed simply through head to head comparisons of treatments. Pressing answers to the question of “which treatments work best for which patients” calls for both dedicated investment in medical efficacy research as well as the adoption of novel conceptual and methodological approaches that are beyond the scope of conventional clinical trials.

To our knowledge, this IBS study is the first to systematically investigate the role of motivation in IBS treatment using a theory based measure with sound psychometric properties. Motivation is often regarded as essential to shaping the outcomes of IBS therapies 7, 42 but has received little empirical study from IBS researchers. We found that rapid responders reported more autonomous motivation to learn behavioral self management skills for IBS than NRR, while NRRS reported higher levels of amotivation. According to self determination theory, amotivation (sample TSRQ-IBS item: “I really don’t know why I would learn self management skills for managing IBS symptoms”) occurs in individuals who lack the intention and willingness to engage in a specific behavior. Self perceptions of incompetence and uncontrollability can account for amotivation, which is linked to behavioral disengagement. The TSRQ-IBS appears to be a psychometrically validated measure of treatment motivation that may be useful in better understanding how motivation impacts IBS treatments whether they are pharmacological or behavioral in nature.

Interestingly, rapid response occurred before patients were formally introduced to cognitive techniques (e.g., prediction testing, evidence based logic, formal problem solving training) that has been characterized 43 as the most powerful behavioral strategy for IBS. This invites speculation about what is going on in during the first 4 weeks sessions that fosters such dramatic and enduring change in a sizable sub set of patients. It is possible that rapid responders were especially responsive to relaxation exercises emphasized during two of the first four week of treatment. This interpretation must be weighed against outcome research showing a mixed track record of efficacy for relaxation as a standalone behavioral technique for IBS 44, 45. Even the studies that support the efficacy of relaxation procedures administered a much longer training schedule (e.g., 6 weeks) than our protocol (2 weeks).

We suspect that symptom monitoring had a stronger hand in expediting early treatment gains. At the first session both CBT treatments, patients were assigned a rather intensive self monitoring regimen (see Appendix for self monitoring record) which included careful tracking of individual GI symptoms, flare ups, the circumstances in which they occurred, and the antecedent and consequent events such as emotional, cognitive, and physical responses. This is called a functional analysis and was carried out on a daily basis through at least week 4. For patients who “spend a lot of time in their heads” worrying about day to day events (“If only…., “what if…?”), the task of monitoring situational triggers of IBS flare ups may force them to step outside of themselves and appraise the environment in a more objective, present oriented, flexible, and logical (non threatening) manner. Self monitoring may expedite rapid symptom improvement by fostering cognitive changes (awareness, self reflection, and objective appraisal of the relationship between symptoms fluctuations and situational influences) critical to self regulation,16,46, 47. The cognitive demands of conducting a functional analysis goes beyond the often recommended task of tracking daily symptoms. Successful completion of self monitoring may reveal interactive patterns of cognitions, bodily sensations, emotions, behaviors and the external cues that trigger these response, which sets the stage for self initiated behavioral change. Assignment of self monitoring is a simple, efficient, and potentially beneficial technique that medically oriented IBS practitioners could easily adopt in practices where behavioral medicine treatments are not routinely available.

There are important limitations to this study. As is the case in many psychotherapy trials, our sample included subjects who volunteered for a behavioral treatment for a medical problem. It is possible that our subjects were more psychologically minded, motivated and open to a biobehavioral formulation of their condition than those who did not seek psychological treatment for their IBS. While we did identify differences between rapid responders and non rapid responders on key clinical parameters (e.g. GI symptom relief/improvement, quality of life), our major findings may not necessarily generalize to a broader set of treatment seeking IBS. This trial was designed as a feasibility study and therefore not powered to detect differences between doses of CBT treatments on rapid response. Whether rapid response is (1) more likely to occur in a brief, home based or more intensive, clinic based form of CBT and (2) is unique to CBT (vs. common ingredients of therapies including pharmacological ones48) is an important task of a larger RCT.

Acknowledgments

Grant Support: This research was supported in part by research grants 67878 and 77738 from the National Institutes of Health/NIDDK.

We thank Rebecca Firth and Drs. Ann Marie Carosella, Ed Deci, Terry Wilson, and Ken Holroyd for their invaluable help on this study.

Abbreviations

RR

rapid responder

NRR

non-rapid responder

CBT

cognitive behavioral therapy

QOL

quality of life

Footnotes

The authors have no financial disclosures.

Authorship: study concept and design (JML, SSK); acquisition of data (CP, JML, SSK, GG); analysis and interpretation of data (JML, GG); drafting of the manuscript (JML, LK, GG); critical revision of the manuscript for important intellectual content (JML, LK, SSK); statistical analysis (GG, JML); obtained funding (JML); administrative, technical, or material support (SSK, LK, CP, GG); study supervision (JML)

References

  • 1.Drossman DA. Presidential address: Gastrointestinal illness and the biopsychosocial model. Psychosomatic Medicine. 1997;60:258–267. doi: 10.1097/00006842-199805000-00007. [DOI] [PubMed] [Google Scholar]
  • 2.Ballenger JC, Davidson JR, Lecrubier Y, Nutt DJ, Lydiard RB, Mayer EA. Consensus statement on depression, anxiety, and functional gastrointestinal disorders. J Clin Psychiatry. 2001;62 (Suppl 8):48–51. [PubMed] [Google Scholar]
  • 3.Mulak A, Bonaz B. Irritable bowel syndrome: a model of the brain-gut interactions. Med Sci Monit. 2004;10:RA55–62. [PubMed] [Google Scholar]
  • 4.Wood JD, Alpers DH, Andrews PL. Fundamentals of neurogastroenterology. Gut. 1999;45(Suppl 2):II6–II16. doi: 10.1136/gut.45.2008.ii6. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 5.Lackner JM, Morley S, Dowzer C, Mesmer C, Hamilton S. Psychological treatments for irritable bowel syndrome: a systematic review and meta-analysis. J Consult Clin Psychol. 2004;72:1100–13. doi: 10.1037/0022-006X.72.6.1100. [DOI] [PubMed] [Google Scholar]
  • 6.Mayer EA. Clinical practice. Irritable bowel syndrome. N Engl J Med. 2008;358:1692–9. doi: 10.1056/NEJMcp0801447. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 7.Drossman DA, Toner BB, Whitehead WE, Diamant NE, Dalton CB, Duncan S, Emmott S, Proffitt V, Akman D, Frusciante K, Le T, Meyer K, Bradshaw B, Mikula K, Morris CB, Blackman CJ, Hu Y, Jia H, Li JZ, Koch GG, Bangdiwala SI. Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. Gastroenterology. 2003;125:19–31. doi: 10.1016/s0016-5085(03)00669-3. [DOI] [PubMed] [Google Scholar]
  • 8.Blanchard EB, Lackner JM, Gusmano R, Gudleski GD, Sanders K, Keefer L, Krasner S. Prediction of treatment outcome among patients with irritable bowel syndrome treated with group cognitive therapy. Behav Res Ther. 2006;44:317–37. doi: 10.1016/j.brat.2005.01.003. [DOI] [PubMed] [Google Scholar]
  • 9.Paul G. Strategy of outcome research in psychotherapy. Journal of Consulting Psychology. 1967;31:109–118. doi: 10.1037/h0024436. [DOI] [PubMed] [Google Scholar]
  • 10.Breslin FC, Sobell MB, Sobell LC, Buchan G, Cunningham JA. Toward a stepped care approach to treating problem drinkers: the predictive utility of within-treatment variables and therapist prognostic ratings. Addiction. 1997;92:1479–89. [PubMed] [Google Scholar]
  • 11.Wadden TA, Letizia KA. Predictors of attrition and weight loss in pateitns treated by modeare and severe caloric restriction. In: Wadden TA, VanItallie B, editors. Treatment of seriously obese pateint. New York: Plenum; 1992. pp. 283–308. [Google Scholar]
  • 12.Agras WS, Walsh T, Fairburn CG, Wilson GT, Kraemer HC. A multicenter comparison of cognitive-behavioral therapy and interpersonal psychotherapy for bulimia nervosa. Arch Gen Psychiatry. 2000;57:459–66. doi: 10.1001/archpsyc.57.5.459. [DOI] [PubMed] [Google Scholar]
  • 13.Ilardi SS, Craighead WE. The role of nonspecific in cognitive-behavior therapy for depression. Clinical Psychology: Science and Practice. 1994;1:138–156. [Google Scholar]
  • 14.Elkin I, Pilkonis PA, Docherty JP, Sotsky SM. Conceptual and methodological issues in comparative studies of psychotherapy and pharmacotherapy, II: Nature and timing of treatment effects. Am J Psychiatry. 1988;145:1070–6. doi: 10.1176/ajp.145.9.1070. [DOI] [PubMed] [Google Scholar]
  • 15.Fennell MJV, Teasdale JD. Cognitive therapy for depression: Individual differences and the process of change. Cognitive Therapy and Research. 1987;11:253–271. [Google Scholar]
  • 16.Wilson GT. Rapid response to cognitive behavior therapy. Clinical Psychology: Science and Practice. 1999;6:289–292. [Google Scholar]
  • 17.Lackner JM, Jaccard J, Krasner SS, Katz LA, Gudleski GD, Holroyd K. Self-administered cognitive behavior therapy for moderate to severe irritable bowel syndrome: clinical efficacy, tolerability, feasibility. Clin Gastroenterol Hepatol. 2008;6:899–906. doi: 10.1016/j.cgh.2008.03.004. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 18.Lackner JM. Controlling IBS the drug-free way: A 10-step plan for symptom relief. Stewart, Tabori, & Chang; 2007. [Google Scholar]
  • 19.Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11:395–402. doi: 10.1046/j.1365-2036.1997.142318000.x. [DOI] [PubMed] [Google Scholar]
  • 20.Lackner JM, Krasner SS, Holroyd K. IBS Management Self Efficacy Scale. Buffalo: University at Buffalo, SUNY; 2004. [Google Scholar]
  • 21.Lackner JM, Krasner SS, Quigley B, Gudleski GD, Powell C, Katz L, Sampath P, Holroyd K. Cognitive behavior therapy improves severity of IBS Symptoms by modifying patients’ illness belifs: Results of a randomized clinical trial. Gastroenterology. 2007;132(Suppl 2):A-520. [Google Scholar]
  • 22.Lackner JM, Holroyd K. Locus of control scale-IBS version (a self report measure for assessing perceived control in IBS patients) Buffalo: University at Buffalo, SUNY; 2004. [Google Scholar]
  • 23.Lackner JM, Holroyd KA, Gudleski GD, Krasner SS, Katz LA, Powell C, Sampeth PK, Firth RS, Yates BL. A randomized controlled trial of therapist-adminsitered vs. minimal contact cognitive behavioral treatment for moderate to severe IBS. Gastroenterology. 2006;130:A-78. [Google Scholar]
  • 24.Lackner JM, Deci EL. Treatment self regulation questionnaire for IBS (a self report questionnaire of treatment motivation specific to IBS patients) Buffalo: University at Buffalo, SUNY; 2004. [Google Scholar]
  • 25.Ryan RM, Connell JP. Perceived locus of causality and internalization: examining reasons for acting in two domains. J Pers Soc Psychol. 1989;57:749–61. doi: 10.1037//0022-3514.57.5.749. [DOI] [PubMed] [Google Scholar]
  • 26.Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998;43:400–11. doi: 10.1023/a:1018831127942. [DOI] [PubMed] [Google Scholar]
  • 27.Derogatis LR. Brief Symptom Inventory. National Computer Systems; 1993. [Google Scholar]
  • 28.Irvine EJ, Whitehead WE, Chey WD, Matsueda K, Shaw M, Talley NJ, Veldhuyzen van Zanten SJ. Design of Treatment Trials for Functional Gastrointestinal Disorders. Gastroenterology. 2006;130:1538–1551. doi: 10.1053/j.gastro.2005.11.058. [DOI] [PubMed] [Google Scholar]
  • 29.Lachic JM. Statistical considerations in the intent-to-treat principle. Controlled Clinical Trials. 2000;21:167–189. doi: 10.1016/s0197-2456(00)00046-5. [DOI] [PubMed] [Google Scholar]
  • 30.Gross D, Fogg L. A Critical Analysis of the Intent-to-Treat Principle in Prevention Research. The Journal of Primary Prevention. 2004;25:475–489. [Google Scholar]
  • 31.Lembo T, Wright RA, Bagby B, Decker C, Gordon S, Jhingran P, Carter E. Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome. Am J Gastroenterol. 2001;96:2662–2670. doi: 10.1111/j.1572-0241.2001.04128.x. [DOI] [PubMed] [Google Scholar]
  • 32.Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, Ueno R. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther. 2009;29:329–41. doi: 10.1111/j.1365-2036.2008.03881.x. [DOI] [PubMed] [Google Scholar]
  • 33.Camilleri M, Chey WY, Mayer EA, Northcutt AR, Heath A, Dukes GE, McSorley D, Mangel AM. A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome. Arch Intern Med. 2001;161:1733–40. doi: 10.1001/archinte.161.14.1733. [DOI] [PubMed] [Google Scholar]
  • 34.Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11:395 – 402. doi: 10.1046/j.1365-2036.1997.142318000.x. [DOI] [PubMed] [Google Scholar]
  • 35.Howard KI, Kopta SM, Krause MS, Orlinsky DE. The dose-effect relationship in psychotherapy. Am Psychol. 1986;41:159–64. [PubMed] [Google Scholar]
  • 36.American College of Gastroenterology IBS Task Force. An Evidence-Based Position Statement on the Management of Irritable Bowel Syndrome. American Journal of Gastroenterology. 2008;104:S1–S35. doi: 10.1038/ajg.2008.122. [DOI] [PubMed] [Google Scholar]
  • 37.Barkham M, Shapiro DA, Hardy GE, Rees A. Psychotherapy in two-plus-one sessions: Outcomes of a randomized controlled trial of cognitive-behavioral and psychodynamic-interpersonal therapy for subsyndromal depression. Journal of Consulting and Clinical Psychology. 1999;67:201–211. doi: 10.1037//0022-006x.67.2.201. [DOI] [PubMed] [Google Scholar]
  • 38.Quitkin FM, Rabkin JG, Stewart JW, McGrath PJ, Harrison W, Ross DC, Tricamo E, Fleiss J, Markowitz J, Klein DF. Heterogeneity of clinical response during placebo treatment. American Journal of Psychiatry. 1991;148:193–196. doi: 10.1176/ajp.148.2.193. [DOI] [PubMed] [Google Scholar]
  • 39.Pear R. US to Study Effectiveness of Treatments. New York Times; New York: 2009. p. A10. [Google Scholar]
  • 40.Ellis P. In: Research on the Comparative Effectiveness of Medical Treatments. Skeen J, editor. Washington, D.C: Congressional Budget Office; 2007. [Google Scholar]
  • 41.Lackner JM, Jaccard J, Krasner SS, Katz LA, Blanchard EB. How does cognitive behaioral therapy for IBS work: A structural equation modeling analysis of results from a randomized controlled trial. Gastroenterology. 2006;130:A-504. [Google Scholar]
  • 42.Hadley SK, Gaarder SM. Treatment of irritable bowel syndrome. Am Fam Physician. 2005;72:2501–6. [PubMed] [Google Scholar]
  • 43.Blanchard EB. Irritable bowel syndrome: Psychosocial assessment and treatment. APA; 2001. [Google Scholar]
  • 44.Keefer L, Blanchard EB. The effects of relaxation response meditation on the symptoms of irritable bowel syndrome: results of a controlled treatment study. Behaviour Research and Therapy. 2001;39:801–811. doi: 10.1016/s0005-7967(00)00078-4. [DOI] [PubMed] [Google Scholar]
  • 45.Boyce PM, Talley NJ, Balaam B, Koloski NA, Truman G. A randomized controlled trial of cognitive behavior therapy, relaxation training, and routine clinical care for the irritable bowel syndrome. Am J Gastroenterol. 2003;98:2209–18. doi: 10.1111/j.1572-0241.2003.07716.x. [DOI] [PubMed] [Google Scholar]
  • 46.Bandura A. Social foundations of thought and action: A social cognitive theory. Prentice-Hall; 1986. [Google Scholar]
  • 47.Kanfer FH. Self-regulation: Research, issues, and speculation. Appleton-Century-Crofts; 1970. [Google Scholar]
  • 48.Krupnick JL, Sotsky SM, Simmens S, Moyer J, Elkin I, Watkins J, Pilkonis PA. The role of the therapeutic alliance in psychotherapy and pharmacotherapy outcome: findings in the National Institute of Mental Health Treatment of Depression Collaborative Research Program. J Consult Clin Psychol. 1996;64:532–9. doi: 10.1037//0022-006x.64.3.532. [DOI] [PubMed] [Google Scholar]

RESOURCES