Clinical trial NCT05953779: Personalized Need-focused Single Session Intervention
Official title: Randomized Controlled Trial for Personalized Need-focused Single-Session Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression and/or Anxiety in the Mild-to-moderate Range
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: United States - Israel Binational Science Foundation
First posted: 2023-07-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial with 2 conditions: Experimental condition (personalized-selected intervention) and control condition (randomly-selected or standard intervention focused on emotion-regulation).
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Hamilton-Depression Rating Scale
timeFrame: Change between pre-intervention and 1 month post-intervention
measure: Montgomery-Asberg Depression Rating Scale
timeFrame: Change between pre-intervention and 1 month post-intervention
measure: Hamilton-Anxiety Rating Scale
timeFrame: Change between pre-intervention and 1 month post-intervention
Secondary outcomes:
measure: PHQ-8
timeFrame: Immediately prior to intervention, and again at 1 and 3 months post-intervention
measure: GAD-7
timeFrame: Immediately prior to intervention, and again at 1 and 3 months post-intervention
measure: DASS
timeFrame: Immediately prior to intervention, and again at 1 and 3 months post-intervention
Other outcomes:
measure: PANAS
timeFrame: Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
measure: ERQ
timeFrame: Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
measure: DERS-18
timeFrame: Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
measure: PSQI
timeFrame: Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
measure: IIP-32
timeFrame: Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
city: Ramat Gan
country: Israel
facility: Bar-Ilan University
Study officials:
References: