Development of Limited Contact CBT Treatment for IBS
Condition: IBS
Study type: Interventional

Summary: 
      An accumulating body of evidence indicates that a specific psychological treatment called
      cognitive behavioral therapy (CBT) is associated with significant reductions in pain and
      bowel dysfunction of irritable bowel syndrome (IBS). Despite its apparent efficacy, the
      clinical effectiveness of CBT (i.e., its generalizability, feasibility, cost effectiveness)
      has not been adequately established due partly to its duration, cost, and limited
      accessibility. As the "second generation" of IBS treatments undergo development and
      validation, it has become increasingly clear that efficacy demonstration is a necessary but
      not sufficient condition of treatment viability. One potential solution to the problem of
      clinical effectiveness is to develop a briefer, largely self administered version of CBT that
      retains the efficacy of standard CBT but is more transportable, accessible, and less costly
      to deliver. To this end, a two-stage project is proposed. The goals of the first stage will
      be to develop, refine, and pilot test an innovative limited therapist contact-CBT protocol
      patterned after treatments proven effective for painful medical disorders with similar
      pathophysiology as IBS. The primary aim of the second stage is to conduct a small randomized
      clinical trial (N = 75 patients meeting Rome II diagnostic criteria) of standard (10 session)
      version of CBT (S-CBT) and limited contact (4 session) version of CBT (LC-CBT) with reference
      to a wait list control to examine their comparative efficacy on multiple indices, including
      IBS symptoms (primary outcome variable), psychological distress, and quality of life.
      Secondary aims are (1) to identify patient characteristics that predict outcome; (2) obtain
      information regarding active change-inducing mechanisms that may underlie treatment outcome;
      and (3) obtain information regarding possible monetary benefits, cost-effectiveness, and
      cost-benefit of S-CBT versus LC-CBT protocols. Data from this trial would set the stage for
      an R01 funded multicenter study with a large, random, and representative sample that could
      establish the clinical effectiveness of LC-CBT and in so doing make a significant
      contribution toward more efficient and effective care of IBS.
    

Detailed description: 
      An accumulating body of evidence indicates that a specific psychological treatment called
      cognitive behavioral therapy (CBT) is associated with significant reductions in pain and
      bowel dysfunction of irritable bowel syndrome (IBS). Despite its apparent efficacy, the
      clinical effectiveness of CBT (i.e., its generalizability, feasibility, cost effectiveness)
      has not been adequately established due partly to its duration, cost, and limited
      accessibility. As the "second generation" of IBS treatments undergo development and
      validation, it has become increasingly clear that efficacy demonstration is a necessary but
      not sufficient condition of treatment viability. One potential solution to the problem of
      clinical effectiveness is to develop a briefer, largely self administered version of CBT that
      retains the efficacy of standard CBT but is more transportable, accessible, and less costly
      to deliver. To this end, a two-stage project is proposed. The goals of the first stage will
      be to develop, refine, and pilot test an innovative limited therapist contact-CBT protocol
      patterned after treatments proven effective for painful medical disorders with similar
      pathophysiology as IBS. The primary aim of the second stage is to conduct a small randomized
      clinical trial (N = 75 patients meeting Rome II diagnostic criteria) of standard (10 session)
      version of CBT (S-CBT) and limited contact (4 session) version of CBT (LC-CBT) with reference
      to a wait list control to examine their comparative efficacy on multiple indices, including
      IBS symptoms (primary outcome variable), psychological distress, and quality of life.
      Secondary aims are (1) to identify patient characteristics that predict outcome; (2) obtain
      information regarding active change-inducing mechanisms that may underlie treatment outcome;
      and (3) obtain information regarding possible monetary benefits, cost-effectiveness, and
      cost-benefit of S-CBT versus LC-CBT protocols. Data from this trial would set the stage for
      an R01 funded multicenter study with a large, random, and representative sample that could
      establish the clinical effectiveness of LC-CBT and in so doing make a significant
      contribution toward more efficient and effective care of IBS.
    

Intervention name(s): Standard CBT (S-CBT); Minimal contact CBT (MC-CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard CBT (S-CBT) is a skills-based training program delivered to patients in 10 weekly, 1-hour sessions.; Minimal contact CBT (MC-CBT) covers the same range of procedures featured in S-CBT but relies extensively on self study materials.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment