Personalized Need-focused Single Session Intervention

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression and/or Anxiety in the Mild-to-moderate Range
• Intervention / Treatment: Behavioral: Clinician-administered Need-focused Single Session Intervention

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).

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eshkol Rafaeli, PhD; Phone Number: +972-3-7384660; Email: eshkol.rafaeli@gmail.com
• Study Contact Backup: Name: Gal Lazarus, PhD; Email: gal.lazarus@gmail.com

Study Locations

• Israel
  • Ramat Gan, Israel, 52900
    • Recruiting
    • Bar-Ilan University
    • Contact: Eshkol Rafaeli, PhD; Phone Number: +972-3-7384660; Email: eshkol.rafaeli@gmail.com
• United States
  • California
    • Berkeley, California, United States, 94720
      • Recruiting
      • University of California, Berkeley
      • Contact: Aaron J. Fisher, PhD; Phone Number: 510-642-8615; Email: afisher@berkeley.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criterion.

* a score of 5 or above on the Hamilton Rating Scale for Depression (HRSD).

Exclusion Criteria based on Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders (DIAMOND).

• Psychotic Disorders (hallucinations or delusions)
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton-Depression Rating Scale	(Range 0-52, higher scores denote greater depression)	Change between pre-intervention and 1 month post-intervention
Montgomery-Asberg Depression Rating Scale	(Range 0-60, higher scores denote greater depression)	Change between pre-intervention and 1 month post-intervention
Hamilton-Anxiety Rating Scale	(Range 0-56, higher scores denote greater anxiety); will be used in lieu of Hamilton-Depression ratings for individuals whose Hamilton-Anxiety scores are higher than their Hamilton-Depression scores.	Change between pre-intervention and 1 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-8	(Range 0-24, higher scores denote greater depression)	Immediately prior to intervention, and again at 1 and 3 months post-intervention
GAD-7	(Range 0-21, higher scores denote greater anxiety)	Immediately prior to intervention, and again at 1 and 3 months post-intervention
DASS	(Range 0-63, higher scores denote greater depression, anxiety, and stress)	Immediately prior to intervention, and again at 1 and 3 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PANAS	Positive and negative affect schedule (20 items)	Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
ERQ	Emotion Regulation Questionnaire	Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
DERS-18	Difficulties in Emotion Regulation	Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
PSQI	Pittsburgh Sleep Quality Index	Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
IIP-32	Inventory of Interpersonal Problems	Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

Collaborators and Investigators

• Sponsor: Bar-Ilan University, Israel
• Collaborators: University of California, Berkeley; United States - Israel Binational Science Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: March 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: ER13323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data will be made available through the osf.io platform or similar platforms.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No