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Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: A Treatment Development and Pilot Study (CBT-AR Pilot)

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Mass General Brigham

Status

Completed

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Treatments

Behavioral: CBT-AR

Study type

Interventional

Funder types

Other

Identifiers

NCT02963220
2016P002108

Details and patient eligibility

About

The primary aim of this study is to pilot cognitive behavioral therapy (CBT-AR)for avoidant/restrictive food intake disorder (ARFID) in one study for children and adolescents (ages 10-17 years) and one study for adults (ages 18-65 years).

Full description

This study is designed to pilot the CBT-AR treatment in youth with ARFID to determine treatment acceptability and efficacy.This includes evaluating the efficacy and acceptability of CBT-AR in reducing primary ARFID symptoms from pre- to post-treatment, and to assess whether improvement in individual symptoms is related to the timing of relevant interventions. The investigators hypothesize that from pre-treatment to post-treatment, subjects with ARFID will decrease severity of self-reported ARFID symptoms, decrease self-reported anxiety and depression, and improve psychosocial functioning. The investigators further hypothesize that overall, subjects with ARFID will have reduced phobic avoidance, sensory sensitivity, and/or low appetite in comparison to their pre-treatment symptoms.

Enrollment

35 patients

Sex

All

Ages

10 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males and females; ages 10-17 years AND 18-65 years with avoidant/restrictive eating disorder or avoidant/restrictive eating patterns, characterized by either (i) Eating Disorder Assessment-5 (EDA-5) (ii) Kiddie Schedule for Affective Disorders and Schizophrenia for School Age Children-Present and Lifetime Version (KSADS-PL)

Exclusion criteria

  • Use of systemic hormones, pregnancy or breastfeeding within eight weeks
  • History of psychosis by KSADS-PL
  • Substance or Alcohol Use Disorder active within the past month by KSADS-PL
  • Active suicidal ideation
  • Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
  • Any feeding or eating disorder other than ARFID determined by EDA-5
  • Any clinically significant disordered eating as evidenced by EDE-Q global > 4.0 or self-induced vomiting, laxatives, diuretics, purposeful fasting, or compensatory exercise in past 28 days
  • Medical history of intellectual disability (IQ< 70)
  • Has previously received more than 4 hours of CBT for ARFID in the past
  • Is currently receiving another form of psychosocial treatment for ARFID (e.g., occupational therapy, speech therapy, another form of psychotherapy) and is unable to discontinue that treatment for the duration of this study.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

CBT-AR
Experimental group
Description:
There is only one arm in this study - all participants will be in the same arm, as all participants will receive CBT-AR. There is no control group.
Treatment:
Behavioral: CBT-AR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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