Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2023-01-08
2024-09-30
Brief Summary
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Detailed Description
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All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. Participants will also meet with the therapist for a 10-minute remote check-in two weeks following the single session.
All interventions include standard psychoeducational components. Participants randomized to the personalization arm of the study will be given an intervention matched to their most pressing psychosocial need. Participants randomized to the control condition will receive a standard intervention (at the UCB site) or a randomly selected one (at the BIU site). Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology.
The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models and include emotional stability, predictability, acceptance, competence, self-esteem, autonomy, and pleasure. The primary unmet need for each individual will be determined by a conditional entropy algorithm. Simply, the presence versus absence of subjective distress will be measured eight times per day for 30 days. Concurrently, the presence versus absence of need frustration will also be measured eight times per day for 30 days. Utilizing a k-fold cross-validated estimation, conditional entropy will be used to determine the need that best reduces the uncertainty in subjective distress (that is, best explains its presentation probabilistically).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Personalized Intervention
The intervention approach taken in this RCT is focused on unmet psychological needs (predictability, belonging, competence, self-worth, autonomy, and playfulness). For each need, a specific 90-minute intervention has been developed.
The primary unmet need for each individual will be determined by a conditional entropy algorithm. Simply, the presence versus absence of subjective distress will be measured eight times per day for 30 days. Concurrently, the presence versus absence of need frustration will also be measured eight times per day for 30 days. Utilizing a k-fold cross-validated estimation, conditional entropy will be used to determine the need that best reduces the uncertainty in subjective distress (that is, best explains its presentation probabilistically).
At both sites, the experimental condition will consist of an algorithmically-chosen intervention. The choice will be made based on data collected during thirty days of ecological momentary assessment.
Clinician-administered Need-focused Single Session Intervention
All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. They will also meet with the therapist for a 10-minute remote check-in two weeks following the single session. All interventions include standard psychoeducational components. Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology. The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models.
Non-personalized Intervention
The intervention approach taken in this RCT is focused on unmet psychological needs (predictability, belonging, competence, self-worth, autonomy, and playfulness). For each need, a specific 90-minute intervention has been developed.
At the BIU site, the active control condition will consist of an intervention chosen randomly (out of the six mentioned above).
At the UCB site, the active control condition will consist of a standard intervention addressing emotion regulation difficulties.
Clinician-administered Need-focused Single Session Intervention
All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. They will also meet with the therapist for a 10-minute remote check-in two weeks following the single session. All interventions include standard psychoeducational components. Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology. The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models.
Interventions
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Clinician-administered Need-focused Single Session Intervention
All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. They will also meet with the therapist for a 10-minute remote check-in two weeks following the single session. All interventions include standard psychoeducational components. Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology. The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Past or current mania, current hypo-mania.
* Anorexia Disorder
* Current Obsessive-Compulsive and related Disorders rated as moderate and above.
* Alcohol or drug abuse rated as moderate and above.
* Panic Disorder rated as moderate and above.
* Agoraphobia rated as moderate and above.
* Premenstrual dysphoric disorder rated as moderate and above.
* Current Post-Traumatic Stress Disorder rated as moderate and above.
* binge eating rated as moderate and above.
* Phobia rated as severe and above.
* Somatic symptom disorder rated as severe and above.
* Illness Anxiety Disorder rated as severe and above.
* MDD rated as severe and above.
* GAD rated as severe and above.
* Social Anxiety rated as severe and above.
* Separation anxiety rated as severe and above.
18 Years
ALL
No
Sponsors
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Bar-Ilan University, Israel
OTHER
University of California, Berkeley
OTHER
United States - Israel Binational Science Foundation
OTHER
Responsible Party
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Prof. Eshkol Rafaeli
Professor
Locations
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University of California, Berkeley
Berkeley, California, United States
Bar-Ilan University
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ER13323
Identifier Type: -
Identifier Source: org_study_id
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