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Affective Treatment Study
The goal of this study is to determine whether subjects who do not show expected clinical improvement during the early course of positive affect treatment (PAT) would benefit from switching to an alternative psychosocial treatment (negative affect treatment) that is designed to instead target and improve deficits in threat sensitivity. Participants will complete laboratory tests, psychiatric assessments, and self-report questionnaires as part of the study. The total length of participation is around 5 months.
Anhedonia, or loss of interest or pleasure in usual activities, is characteristic of depression, some types of anxiety, as well as substance abuse and schizophrenia. Specifically, anhedonia is associated with deficits in the appetitive reward system. Previously, our team developed a novel transdiagnostic psychosocial treatment for anhedonia that was designed to specifically target and improve deficits in reward sensitivity: Positive Affect Treatment (PAT). In clinical trials, PAT has been proven to be clinically effective at increasing positive affect, reducing negative affect, and improving depression, anxiety and stress (Craske et al., 2019, Craske et al., 2023). Like all psychosocial interventions, however, PAT is not effective for every individual. The goal of the current study is to determine whether subjects who do not show expected clinical improvement during the early course of PAT would benefit from switching to an alternative psychosocial treatment (Negative Affect Treatment \[NAT\]) that is designed to instead target and improve deficits in threat sensitivity. Upon enrollment, each participant will complete a two-week long baseline assessment period before beginning treatment. On the first day of the baseline period, participants will complete a brief anhedonia interview, which will be conducted by an independent interviewer over the phone or HIPAA-compliant Zoom. For this interview, participants will answer 3 items using a 4-point rating scale, which will then be rated by the interviewer. In addition, participants will complete a battery of psychosocial questionnaires (approx. 25 minutes) remotely via REDCap to assess their mood, current symptoms and impairment. The participant will complete this assessment (including the clinical interview and questionnaires) a total of four times throughout the study: (1) the first day of the baseline period, (2) just before their first treatment session (i.e., the last day of the baseline period), (3) at the point of switching to the second treatment stage, and (4) just after completing treatment. In addition, beginning on the first day of their baseline period and throughout the remainder of their participation, subjects will be asked to provide daily mood ratings using a 0-10 scale. Following the baseline period, participants will receive weekly 60-minute individual therapy sessions remotely (via HIPAA-compliant Zoom) with a highly trained psychotherapist. Before each session, participants will complete a short (approx. 7-10 minutes) series of surveys/questions to monitor their symptoms and other important clinical changes. All participants will receive a variation of the same treatment (PAT), however, participants who do not show the expected clinical improvement during the first 3-5 sessions of PAT will be switched to an alternative treatment (NAT). Participants who show clinical improvement in response to PAT will receive a total of 8 weeks of therapy. Participants who fail to show signs of clinical improvement in response to the first 3-5 sessions of PAT will discontinue PAT and begin NAT; they will receive a total of 8 weeks of therapy with NAT (in addition to the 3-5 weeks of therapy with PAT that they already completed).
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
University of California, Los Angeles
Los Angeles, California, United States
Southern Methodist University
Dallas, Texas, United States
Start Date
March 25, 2024
Primary Completion Date
March 25, 2025
Completion Date
March 25, 2025
Last Updated
May 11, 2025
10
ACTUAL participants
Positive Affect Treatment
BEHAVIORAL
Positive Affect Treatment and Negative Affect Treatment
BEHAVIORAL
Lead Sponsor
University of California, Los Angeles
Collaborators
NCT07360600
NCT06793397
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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