NCT05953779

Personalized Need-focused Single Session Intervention

Randomized Controlled Trial for Personalized Need-focused Single-Session Interventions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Bar-Ilan University, Israel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis.

Detailed description

This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis. 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

• Depression and/or Anxiety in the Mild-to-moderate Range

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2023-01-08
• Primary completion: 2024-07-31
• Completion: 2024-09-30
• First posted: 2023-07-20
• Last updated: 2023-07-20

Locations

2 sites across 2 countries: United States, Israel