Positive Affect Treatment (PAT) to Target Reward Mechanisms in Anorexia Nervosa

NCT04007900 | Completed

• 1 other identifier: PSYCH-2018-27082
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed research is to determine the extent to which Positive Affect Treatment (PAT), a novel treatment targeting reward mechanisms, can effectively target the psychological reward deficits that maintain anorexia nervosa (AN), and thus improve clinical symptoms.

Conditions

Anorexia Nervosa; Anorexia

Keywords

positive affect treatment

Outcome Measures

Primary Outcomes (1)

• Efficacy: Change in BMI

  Body mass index (BMI) will be calculated based on height and weight measure by a stadiometer and calibrated scale during a medical examination. Change in BMI (kg/m2) will be calculated from baseline to 20-weeks. Increase in BMI in the treatment group vs control will be considered a measure of efficacy of the treatment.

  20-weeks

Study Arms (2)

Positive Affect Treatment

EXPERIMENTAL

Individuals randomized to the intervention will participate in 20 therapy visits. Before each therapy visit, the participant will meet briefly with a member of the research staff, who will measure weight (blind to the participant) and administer the CHEDS, PANAS, and a pre-session feedback form that will assess how helpful the skills learned in the prior session had been over the past week. After the session, the participant will complete the post-session feedback form, which will assess how helpful the skills he or she perceived the skills from this session to be. These procedures will take approximately 10 minutes. Each intervention session will take approximately 50 minutes to complete. Therefore, each intervention visit will be approximately 1 hour long. Therapy sessions will take place either in the private office of a study therapist or in a consultation room of the Ambulatory Research Center.

Behavioral: Positive Affect Treatment

Waitlist

NO INTERVENTION

For participants randomized to the waitlist control, the opportunity will be offered to participate in the intervention following the second assessment (20 weeks following their Baseline assessment).

Interventions

Positive Affect Treatment BEHAVIORAL

PAT was designed as a 15-week intervention delivered in 3 modules. Module 1 (Pleasant Events Scheduling) uses behavioral activation methods to enhance positive experiencing before, during, and after rewarding events. Module 2 (Attending to the Positive) applies cognitive training techniques to promote shifting attention towards rewarding aspects of daily situations and to learn behavior mood associations. Module 3 (Cultivating the Positive) uses mindfulness approaches to foster reward experiencing. Treatment length has been expanded to 20 sessions to enhance the suitability of the intervention for AN and target the reward mechanisms that characterize AN. Additional adaptations include: 1) An emphasis on a mindful balance between reward and inhibition; 2) Additional module on shifting attention away from AN-specific rewards; 3) Addition of exercises to work towards long-term life goals and enhance healthy experiences; and 4) Further focus on navigating social rewards.

Positive Affect Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-5 diagnosis of AN (established by the adapted MINI)
• Ability to read and speak in English
• Involvement in ongoing oversight with a primary physical or mental health provider as defined by:
• Identification by the participant of a physical or mental health provider (e.g., physician, psychiatrist, psychologist, masters level social worker, licensed professional clinical counselor, licensed marriage and family therapist) who will serve as the primary provider throughout the study
• Willingness to sign a Release of Information that gives the study therapist the right to discuss any change in medical or psychiatric stability or other health concerns with the participant's identified primary provider.

You may not qualify if:

• Medical instability according to standard guidelines and medical staff judgment
• Acute suicidality, current substance use disorder, psychosis, or mania requiring specialized treatment
• Lacking capacity to consent
• Current pregnancy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Anorexia

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: July 5, 2019
• Study Start: May 31, 2019
• Primary Completion: July 12, 2022
• Study Completion: March 31, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

US (1)