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Personalized Need-focused Single Session Intervention

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clinician-administered Need-focused Single Session Intervention
Sponsored by
Bar-Ilan University, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression and/or Anxiety in the Mild-to-moderate Range

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, BerkeleyRecruiting
  • Bar-Ilan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized Intervention

Non-personalized Intervention

Arm 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.

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.

Outcomes

Primary Outcome Measures

Hamilton-Depression Rating Scale
(Range 0-52, higher scores denote greater depression)
Montgomery-Asberg Depression Rating Scale
(Range 0-60, higher scores denote greater depression)
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.

Secondary Outcome Measures

PHQ-8
(Range 0-24, higher scores denote greater depression)
GAD-7
(Range 0-21, higher scores denote greater anxiety)
DASS
(Range 0-63, higher scores denote greater depression, anxiety, and stress)

Full Information

First Posted
March 18, 2023
Last Updated
July 18, 2023
Sponsor
Bar-Ilan University, Israel
Collaborators
University of California, Berkeley, United States - Israel Binational Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05953779
Brief Title
Personalized Need-focused Single Session Intervention
Official Title
Randomized Controlled Trial for Personalized Need-focused Single-Session Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bar-Ilan University, Israel
Collaborators
University of California, Berkeley, United States - Israel Binational Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression and/or Anxiety in the Mild-to-moderate Range

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
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.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Non-personalized Intervention
Arm Type
Active Comparator
Arm 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 Type
Behavioral
Intervention Name(s)
Clinician-administered Need-focused Single Session Intervention
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.
Primary Outcome Measure Information:
Title
Hamilton-Depression Rating Scale
Description
(Range 0-52, higher scores denote greater depression)
Time Frame
Change between pre-intervention and 1 month post-intervention
Title
Montgomery-Asberg Depression Rating Scale
Description
(Range 0-60, higher scores denote greater depression)
Time Frame
Change between pre-intervention and 1 month post-intervention
Title
Hamilton-Anxiety Rating Scale
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.
Time Frame
Change between pre-intervention and 1 month post-intervention
Secondary Outcome Measure Information:
Title
PHQ-8
Description
(Range 0-24, higher scores denote greater depression)
Time Frame
Immediately prior to intervention, and again at 1 and 3 months post-intervention
Title
GAD-7
Description
(Range 0-21, higher scores denote greater anxiety)
Time Frame
Immediately prior to intervention, and again at 1 and 3 months post-intervention
Title
DASS
Description
(Range 0-63, higher scores denote greater depression, anxiety, and stress)
Time Frame
Immediately prior to intervention, and again at 1 and 3 months post-intervention
Other Pre-specified Outcome Measures:
Title
PANAS
Description
Positive and negative affect schedule (20 items)
Time Frame
Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
Title
ERQ
Description
Emotion Regulation Questionnaire
Time Frame
Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
Title
DERS-18
Description
Difficulties in Emotion Regulation
Time Frame
Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
Title
PSQI
Description
Pittsburgh Sleep Quality Index
Time Frame
Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention
Title
IIP-32
Description
Inventory of Interpersonal Problems
Time Frame
Up to six weeks prior to intervention, and again at 1 and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eshkol Rafaeli, PhD
Phone
+972-3-7384660
Email
eshkol.rafaeli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gal Lazarus, PhD
Email
gal.lazarus@gmail.com
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron J. Fisher, PhD
Phone
510-642-8615
Email
afisher@berkeley.edu
Facility Name
Bar-Ilan University
City
Ramat Gan
ZIP/Postal Code
52900
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eshkol Rafaeli, PhD
Phone
+972-3-7384660
Email
eshkol.rafaeli@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified data will be made available through the osf.io platform or similar platforms.

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Personalized Need-focused Single Session Intervention

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