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Reducing Depressive Symptoms in Physically Ill Youth

3 januari 2020 bijgewerkt door: Eva Szigethy, University of Pittsburgh

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

76

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Children's Hospital-Boston
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • Children's Hospital of Pittsburgh

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

9 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cognitive Behavioral Therapy
Primary & Secondary Control Enhancement Training (PASCET)

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)

Actieve vergelijker: Supportive Non-Directive Therapy (SNDT)
Supportive Non-Directive Therapy
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in CDRS at 3 months
Tijdsspanne: Month 0, Month 3
Change in Child Depression Rating Scale (CDRS) score from month 0 assessment to three month assessment.
Month 0, Month 3

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in KSADS diagnosis at 3 months
Tijdsspanne: Month 0, Month 3
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pediatric Crohns Disease Index
Tijdsspanne: Month 0, Month 3
Clinician rated instrument of IBD activity which includes symptoms and objective lab results.
Month 0, Month 3
Pediatric Ulcerative Colitis Index
Tijdsspanne: Month 0, Month 3
Clinician rated instrument of gastrointestinal symptoms.
Month 0, Month 3
IMPACT 3
Tijdsspanne: Month 0, Month 3
Health-related quality life measure. Self report.
Month 0, Month 3

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Eva Szigethy, MD, PhD, University of Pittsburgh/ Children's Hospital of Pittsburgh

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2007

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 december 2019

Studieregistratiedata

Eerst ingediend

21 september 2007

Eerst ingediend dat voldeed aan de QC-criteria

21 september 2007

Eerst geplaatst (Schatting)

26 september 2007

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 januari 2020

Laatste update ingediend die voldeed aan QC-criteria

3 januari 2020

Laatst geverifieerd

1 januari 2020

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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