Recruiting

Personalized Intervention

Sponsor:

Bar-Ilan University, Israel

Code:

NCT05953779

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinician-administered Need-focused Single Session Intervention

Study Details

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

Study ID

NCT05953779

Start date

Jan 8, 2023

Status verified date

Jul, 2023

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Hamilton-Depression Rating Scale [ Time Frame: Change between pre-intervention and 1 month post-intervention ]
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: Change between pre-intervention and 1 month post-intervention ]
  • Hamilton-Anxiety Rating Scale [ Time Frame: Change between pre-intervention and 1 month post-intervention ]

Central Contacts and Locations

Central contacts

Locations

University of California, Berkeley

Recruiting

Berkeley, California, United States, 94720

Contacts

More Information

Sponsor

Bar-Ilan University, Israel

Last update posted

Jul 20, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bar-Ilan University, Israel on 2023-07-20.