Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488859
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-24
Brief Title:
Affect Treatment for Depression and Anxiety TAD Pilot
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Affective Treatment Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 ie 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 surveysquestions 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
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 ie 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 surveysquestions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None