Use of Psychologist-administered Cognitive Behavioral Therapy (CBT) or Self-administered CBT for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05377840
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psychologist-administered Cognitive Behavioral Therapy — BEHAVIORAL
    CBT is a combined psycho-social intervention that aims to improve overall mental health focusing on developing coping strategies. For psychologist-administered CBT: Participants will have individual weekly sessions (virtually) lasting 60 minutes each over an 8-week period with 1 follow-up maintenance session at week 12.
  • Self-Administered Cognitive Behavioral Therapy — BEHAVIORAL
    CBT is a combined psycho-social intervention that aims to improve overall mental health focusing on developing coping strategies. For self-administered CBT: Participants will be given a book written for patients on CBT for IBD with instructions on how to self-administer CBT.

Study Details

This is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with IBD can be improved with CBT compared to those treated with SKY.

Key Dates

Start date
Jul 5, 2022
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Psychologist-administered Cognitive Behavioral Therapy
    Participants in this arm will participate in psychologist-administered CBT to assess the impact it will have on anxiety or depression among patients with inflammatory bowel disease
  • Experimental: Self-administered Cognitive Behavioral Therapy
    Participants in this arm will be given a patient education book that teaches how to self-administer cognitive behavioral therapy to assess the impact it will have on anxiety or depression among patients with inflammatory bowel disease

Primary Outcome Measure

Change from baseline in anxiety scores using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire [ Time Frame: baseline, week 6, week 12, week 24 and week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Yale New Haven Hospital· New Haven, CT

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