UnknownNot Applicable

Personalized Need-focused Single Session Intervention

United States, Israel240 participantsStarted 2023-01-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Hamilton-Depression Rating Scale

Timeframe: Change between pre-intervention and 1 month post-intervention

Montgomery-Asberg Depression Rating Scale

Timeframe: Change between pre-intervention and 1 month post-intervention

Hamilton-Anxiety Rating Scale

Timeframe: Change between pre-intervention and 1 month post-intervention

Trial details

NCT IDNCT05953779

SponsorBar-Ilan University, Israel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

Contact for this trial

Eshkol Rafaeli, PhD

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

View on ClinicalTrials.gov More Depression and/or Anxiety in the Mild-to-moderate Range trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Hamilton-Depression Rating Scale

Timeframe: Change between pre-intervention and 1 month post-intervention

Montgomery-Asberg Depression Rating Scale

Timeframe: Change between pre-intervention and 1 month post-intervention

Hamilton-Anxiety Rating Scale

Timeframe: Change between pre-intervention and 1 month post-intervention