## Protocol Section
### Identification Module
**NCT ID:** NCT05953779

**Brief Title:** Personalized Need-focused Single Session Intervention

**Official Title:** Randomized Controlled Trial for Personalized Need-focused Single-Session Interventions

#### Organization Study ID Info
**ID:** ER13323
#### Organization
**Class:** OTHER
**Full Name:** Bar-Ilan University, Israel
### Status Module
#### Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-20

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-18

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-08

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2023-07-20
**Type:** ACTUAL
**Study First Submit Date:** 2023-03-18
**Study First Submit QC Date:** 2023-07-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of California, Berkeley

**Class:** OTHER

**Name:** United States - Israel Binational Science Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Bar-Ilan University, Israel

#### Responsible Party

**Investigator Affiliation:** Bar-Ilan University, Israel

**Investigator Full Name:** Prof. Eshkol Rafaeli

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

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

### Design Module

#### Design Info

**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).

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** 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.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Clinician-administered Need-focused Single Session Intervention

**Label:** Personalized Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Clinician-administered Need-focused Single Session Intervention

**Label:** Non-personalized Intervention

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Non-personalized Intervention

- Personalized Intervention

**Description:** 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.

**Name:** Clinician-administered Need-focused Single Session Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** Positive and negative affect schedule (20 items)

**Measure:** PANAS

**Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

**Description:** Emotion Regulation Questionnaire

**Measure:** ERQ

**Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

**Description:** Difficulties in Emotion Regulation

**Measure:** DERS-18

**Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

**Description:** Pittsburgh Sleep Quality Index

**Measure:** PSQI

**Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

**Description:** Inventory of Interpersonal Problems

**Measure:** IIP-32

**Time Frame:** Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

#### Primary Outcomes

**Description:** (Range 0-52, higher scores denote greater depression)

**Measure:** Hamilton-Depression Rating Scale

**Time Frame:** Change between pre-intervention and 1 month post-intervention

**Description:** (Range 0-60, higher scores denote greater depression)

**Measure:** Montgomery-Asberg Depression Rating Scale

**Time Frame:** Change between pre-intervention and 1 month post-intervention

**Description:** (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.

**Measure:** Hamilton-Anxiety Rating Scale

**Time Frame:** Change between pre-intervention and 1 month post-intervention

#### Secondary Outcomes

**Description:** (Range 0-24, higher scores denote greater depression)

**Measure:** PHQ-8

**Time Frame:** Immediately prior to intervention, and again at 1 and 3 months post-intervention

**Description:** (Range 0-21, higher scores denote greater anxiety)

**Measure:** GAD-7

**Time Frame:** Immediately prior to intervention, and again at 1 and 3 months post-intervention

**Description:** (Range 0-63, higher scores denote greater depression, anxiety, and stress)

**Measure:** DASS

**Time Frame:** Immediately prior to intervention, and again at 1 and 3 months post-intervention

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eshkol.rafaeli@gmail.com

**Name:** Eshkol Rafaeli, PhD

**Phone:** +972-3-7384660

**Role:** CONTACT

**Contact 2:**

**Email:** gal.lazarus@gmail.com

**Name:** Gal Lazarus, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Berkeley

**Contacts:**

***Contact 1:***

- **Email:** afisher@berkeley.edu

- **Name:** Aaron J. Fisher, PhD

- **Phone:** 510-642-8615

- **Role:** CONTACT

**Country:** United States

**Facility:** University of California, Berkeley

**State:** California

**Status:** RECRUITING

**Zip:** 94720

**Location 2:**

**City:** Ramat Gan

**Contacts:**

***Contact 1:***

- **Email:** eshkol.rafaeli@gmail.com

- **Name:** Eshkol Rafaeli, PhD

- **Phone:** +972-3-7384660

- **Role:** CONTACT

**Country:** Israel

**Facility:** Bar-Ilan University

**Status:** RECRUITING

**Zip:** 52900

### IPD Sharing Statement Module

**Description:** De-identified data will be made available through the osf.io platform or similar platforms.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003863

- Term: Depression

### Misc Info Module

- Version Holder: 2024-05-24
