Clinical Trials Directory

Trials / Completed

CompletedNCT04007900

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
University of Minnesota · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Anorexia Nervosa is a serious disorder associated with high medical and psychiatric morbidity, poor quality of life, and the highest mortality rate of any psychiatric illness. Although many individuals with AN ultimately achieve remission, this process of recovery is slow, with only about 1/3 of individuals recovering in the first decade of illness, and is not always associated with an enhanced quality of life. Further, a substantial portion of those with AN do not recover; 20-30% of affected individuals maintain a chronic illness course or die prematurely. Interventions that enhance the probability of long-term remission from adult AN are lacking. Efficacious outpatient treatments have not been identified and, although inpatient treatment can restore healthy weight, up to 50% of patients with AN relapse within a year of discharge. This paucity of effective treatment may be due to existing interventions not targeting key mechanisms of the disorder. Advances in neuroscience have contributed promising insights about the processes that promote AN symptoms. However, these findings have not been adequately integrated into treatment for AN. It is critical that future treatment development utilize emerging research on the mechanisms of AN to develop more effectively targeted interventions. 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. To this end, we propose a small, randomized, wait-list controlled pilot trial of PAT adapted for AN (PAT-AN) to achieve the following aims: To asses the feasibility and acceptability of PAT-AN among individuals with AN and to obtain initial data regarding the potential efficacy of PAT-AN compared to waitlist control on measures of clinical outcome and putative reward mechanisms in AN to inform a future larger randomized, controlled trial of this intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPositive Affect TreatmentPAT 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.

Timeline

Start date
2019-05-31
Primary completion
2022-07-12
Completion
2023-03-31
First posted
2019-07-05
Last updated
2023-04-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04007900. Inclusion in this directory is not an endorsement.