Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.
Hypothesis
- Individuals who receive CBT will show more improvement than individuals who receive SNDT.
Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. Furthermore, the medications used to treat IBR, such as steroids, may induce depression. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease and depression. This study will also be the first to assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.
Participants will be carefully evaluated for depression and those who have clinically significant depression will be randomly assigned to either CBT designed for youth with IBD or supportive therapy sessions. Youth in the CBT group will learn new ways of thinking and acting to reduce symptoms of depression focused on the reconstruction of negative or hopeless physical illness narratives. Parents in the CBT group will participate in three family sessions designed to improve family understanding and communication about the physical illness and about risks for developing depression. Children in the supportive therapy condition will receive social support and information about IBD and depression similar to what they would likely receive from social workers in their pediatric medical clinic. Because emotional difficulties such as the experience of depressive symptoms have been linked with the severity and course of IBD symptoms, this information may enable parents to better help their child cope with his/her physical illness. In addition, participants in both groups may experience reduced depression and improved quality of life.
It is predicted that those in the CBT group will benefit by learning effective strategies for coping with IBD and depression, enhancing their social skills, and improving family communication skills while those in the supportive therapy group will benefit by receiving social support and useful information. The proposed study will help determine which psychosocial approach is of greater benefit for depressed youth with IBD and provide a model for integrating behavioral treatment to decrease both emotional and IBD-related suffering into the comprehensive medical care for IBD in the pediatric population.
Aim 1(primary) Are there differences between the two types of therapy in terms of improving depression.
Aim 2 (secondary) Are there differences between the two types of therapy in terms of improving IBD activity, quality of life, and medication adherence? Aim 3) (secondary) Are there differences between the two types of therapy in terms of improving sleep and pain? Aim 4) (exploratory) Are anxiety, steroid use, and gender moderators of treatment outcome.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Primary & Secondary Control Enhancement Training (PASCET) |
|
| Supportive Non-Directive Therapy (SNDT) | Active Comparator | Supportive Non-Directive Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | Participants will receive 12 weeks of CBT designed for youth with IBD. During sessions, participants will learn new ways of thinking (e.g., reconstruction of personal physical illness narratives, coping strategies, social skills) and behaving (e.g., positive activities, family communication, sleep hygiene, relaxation) to improve emotional and physical outcomes. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up. Other Name: Primary and secondary coping enhancement training (PASCET) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in CDRS at 3 months | Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment. | Month 0, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in KSADS diagnosis at 3 months | Remission of depressive episode as measured by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) from month 0 assessment to 3 month assessment. | Month 0, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Crohns Disease Index | Clinician rated instrument of IBD activity which includes symptoms and objective lab results. | Month 0, Month 3 |
| Pediatric Ulcerative Colitis Index | Clinician rated instrument of gastrointestinal symptoms. |
Inclusion Criteria:
Step 1:
Step 2:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Szigethy, MD, PhD | University of Pittsburgh/ Children's Hospital of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital-Boston | Boston | Massachusetts | 02115 | United States | ||
| Children's Hospital of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. | |
| 27035372 | Derived | Keerthy D, Youk A, Srinath AI, Malas N, Bujoreanu S, Bousvaros A, Keljo D, DeMaso DR, Szigethy EM. Effect of Psychotherapy on Health Care Utilization in Children With Inflammatory Bowel Disease and Depression. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):658-664. doi: 10.1097/MPG.0000000000001207. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003863 | Depression |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Supportive Non-directive Therapy (SNDT) | Behavioral | SNDT is a 12-week non-directive therapeutic intervention. Participants will receive social support and quality information about the warning signs and risk factors for depression. Parent sessions will be provided at the beginning, middle, and end of the treatment to improve family understanding and communication about the physical illness and about risks of developing depression. There will also be 6-month booster sessions during follow-up. |
|
| Month 0, Month 3 |
| IMPACT 3 | Health-related quality life measure. Self report. | Month 0, Month 3 |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| 25822010 | Derived | Szigethy E, Youk AO, Gonzalez-Heydrich J, Bujoreanu SI, Weisz J, Fairclough D, Ducharme P, Jones N, Lotrich F, Keljo D, Srinath A, Bousvaros A, Kupfer D, DeMaso DR. Effect of 2 psychotherapies on depression and disease activity in pediatric Crohn's disease. Inflamm Bowel Dis. 2015 Jun;21(6):1321-8. doi: 10.1097/MIB.0000000000000358. |
| 25208108 | Derived | Srinath A, Young E, Szigethy E. Pain management in patients with inflammatory bowel disease: translational approaches from bench to bedside. Inflamm Bowel Dis. 2014 Dec;20(12):2433-49. doi: 10.1097/MIB.0000000000000170. |
| 24954822 | Derived | Szigethy E, Bujoreanu SI, Youk AO, Weisz J, Benhayon D, Fairclough D, Ducharme P, Gonzalez-Heydrich J, Keljo D, Srinath A, Bousvaros A, Kirshner M, Newara M, Kupfer D, DeMaso DR. Randomized efficacy trial of two psychotherapies for depression in youth with inflammatory bowel disease. J Am Acad Child Adolesc Psychiatry. 2014 Jul;53(7):726-35. doi: 10.1016/j.jaac.2014.04.014. Epub 2014 May 10. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |