Addressing Anxiety and Stress for Healthier Eating in Teens (ASSET)

The Metis Foundation

Status: Unknown

Conditions: Overweight; Mental Disorders; Eating Behavior; Feeding and Eating Disorders; Obesity; Body Weight; Anxiety

Treatments: Behavioral: Cognitive Behavioral Theory (CBT); Behavioral: Interpersonal Psychotherapy (IPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05038033

USUHS.2020-048

Details and patient eligibility

About

Project ASSET will explore the preliminary efficacy of interpersonal therapy, when compared with cognitive behavioral therapy, for reducing anxiety symptoms, preventing excess weight gain, and reducing cardio-metabolic risk in adolescent girls with above-average weight and elevated anxiety. As a pilot for a larger multi-site study, this trial will also test multi-site feasibility, acceptability, and intervention fidelity.

Full description

This study is a randomized controlled trial in which 40 adolescent girls aged 12-17 years-old with weight in the 75th percentile or higher for their age and sex, and elevated anxiety symptoms, will be randomly assigned to an IPT or CBT 12-week group intervention. Approximately 20 adolescent girls will be enrolled at each of two sites: Uniformed Services University (USU) and Colorado State University (CSU). After a screening and baseline assessment, participants will attend an individual meeting with the leaders of their assigned group to learn more about the group process and establish goals. They will then participate in the group program for 12 consecutive weeks. Each group will be led by a PhD-level clinical psychologist and a healthcare trainee. In-person and remote assessments, will be conducted at baseline, in the ~two weeks post-intervention (i.e., 12-week follow-up), and at 1, 2, and 3 years post-intervention. These assessments will consist of body measurements, blood draws for collection markers of metabolic functioning, and surveys and interviews of psychological and social functioning. At baseline, two weeks, and one year post-intervention, participants will also have a week-long period during which they will wear devices collecting activity and physiological data, and complete phone surveys assessing disinhibited eating behaviors, food craving, affect, cognitions, and avoidance behaviors.

Enrollment: 40 estimated patients

Sex: Female

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Participant Inclusion Criteria:

• 12-17-year-old adolescent girls
• BMI ≥ 75th percentile
• Anxiety symptoms: 32 or higher on State Trait Anxiety Inventory for Children-Trait Scale

Participant Exclusion Criteria:

• Any medical condition (as well as pregnancy or breastfeeding)
• Individuals who have any DSM psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study
• Medication impacting mood or weight
• Psychotherapy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Interpersonal Psychotherapy (IPT)

Experimental group

Description:

Interpersonal Psychotherapy program adapted for the prevention of excessive weight gain. Involves one initial 1.5-hour individual session, and 12 weekly 90-minute group sessions.

Treatment:

Behavioral: Interpersonal Psychotherapy (IPT)

Cognitive-Behavioral Therapy (CBT)

Active Comparator group

Description:

The CBT program will match the delivery format and dose of the IPT program. There will be one initial 1.5-hour individual session, and 12 weekly 90-minute group sessions.

Treatment:

Behavioral: Cognitive Behavioral Theory (CBT)