Personalized Need-focused Single Session Intervention

NCT05953779 | Unknown

• 1 other identifier: ER13323
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• PHQ-8

  Immediately prior to intervention, and again at 1 and 3 months post-intervention

• GAD-7

  Immediately prior to intervention, and again at 1 and 3 months post-intervention

• DASS

  Immediately prior to intervention, and again at 1 and 3 months post-intervention

Other Outcomes (5)

• PANAS

  Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

• ERQ

  Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

• DERS-18

  Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

Study Arms (2)

Personalized Intervention

EXPERIMENTAL

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

Non-personalized Intervention

ACTIVE COMPARATOR

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

Interventions

Clinician-administered Need-focused Single Session Intervention BEHAVIORAL

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; Personalized Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead
• University of California, Berkeley: collaborator
• United States - Israel Binational Science Foundation: collaborator

Study Sites (2)

University of California, Berkeley

Berkeley, California, 94720, United States

RECRUITING

Bar-Ilan University

Ramat Gan, 52900, Israel

RECRUITING

Central Study Contacts

Eshkol Rafaeli, PhD

CONTACT

+972-3-7384660; eshkol.rafaeli@gmail.com

Gal Lazarus, PhD

CONTACT

gal.lazarus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants and any care provider and study personnel who interact with them will be blind to condition. The PI will utilize a randomization table to allocate participants to condition, and will inform the front-line study personnel and through them, the care provider, regarding which intervention to use without specifying whether it was personalized or randomly-chosen. The outcomes assessor will be blind even to the type of intervention utilized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized Control Trial with 2 conditions: Experimental condition (personalized-selected intervention) and control condition (randomly-selected or standard intervention focused on emotion-regulation).

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: July 20, 2023
• Study Start: January 8, 2023
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

IL (1); US (1)