Reducing Depressive Symptoms in Physically Ill Youth

NCT00534911 | Completed DMC

• 1 other identifier: 0606136
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Inflammatory Bowel Disease; Depression

Keywords

Depression; Physical Illness; Inflammatory Bowel Disease; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change from baseline in KSADS diagnosis at 3 months

  Month 0, Month 3

Other Outcomes (3)

• Pediatric Crohns Disease Index

  Month 0, Month 3

• Pediatric Ulcerative Colitis Index

  Month 0, Month 3

• IMPACT 3

  Month 0, Month 3

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Primary \& Secondary Control Enhancement Training (PASCET)

Behavioral: Cognitive Behavioral Therapy

Supportive Non-Directive Therapy (SNDT)

ACTIVE COMPARATOR

Supportive Non-Directive Therapy

Behavioral: Supportive Non-directive Therapy (SNDT)

Interventions

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)

Cognitive Behavioral Therapy

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.

Supportive Non-Directive Therapy (SNDT)

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Step 1:
• ages 9 to 17 inclusive
• capable of completing CDI
• meeting diagnostic criteria for CD (the date of diagnosis = date of the first diagnostic test confirming CD)
• absence of mental retardation by history
• having at least one appointment at the GI clinic (this will include patients followed in these clinics as well as those seeking consultation)
• Step 2:
• CDI or CDI-P greater than or equal to 10 at Step 1.
• ages between 9-17 inclusive
• having CD

You may not qualify if:

• history or current episode of bipolar disorder, eating disorder, or psychotic disorder by DSM-IV criteria
• mental retardation by history
• antidepressant medications within one month of assessment
• suicidality with plan or of severity requiring immediate psychiatric hospitalization or significant act involving intentional self-harm (e.g., cutting or overdose, resulting in medical attention)
• unacceptable risk for dangerousness to others as indicated by homicidal (or other violent) ideation, intent or plan or action, or use of illegal weapons
• current pregnancy by history
• substance abuse by history within one month of enrollment other than nicotine dependence
• current treatment with CBT or failure of previous CBT trial for depression judged adequate by at least 12 treatment sessions over a period of less than 1 year conducted by an appropriately trained mental health provider using a manual
• if currently receiving other psychotherapy modalities willingness to suspend treatment for 12-week acute treatment phase of study

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

Children's Hospital-Boston

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

• 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.

  PMID: 40243391 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.

  PMID: 27035372 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.

  PMID: 25822010 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.

  PMID: 25208108 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.

  PMID: 24954822 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eva Szigethy, MD, PhD

  University of Pittsburgh/ Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

US (2)