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Behavioral Intervention
Personalized Single Session Therapy for Depression and Anxiety
N/A
Recruiting
Research Sponsored by Bar-Ilan University, Israel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately prior to intervention, and again at 1 and 3 months post-intervention
Awards & highlights
Study Summary
This trial tests if single-session interventions can reduce anxiety/depression symptoms, and if personalized treatments can be more effective.
Who is the study for?
This trial is for individuals with mild-to-moderate depression or anxiety, as indicated by a score of at least 5 on the Hamilton Rating Scale for Depression. It's not suitable for those with certain severe mental health conditions, substance abuse issues, or eating disorders.Check my eligibility
What is being tested?
The study tests if a single session intervention can significantly improve symptoms of anxiety and depression. It compares a standard session to one personalized using intensive data analysis to see if customization offers extra benefits.See study design
What are the potential side effects?
Since this trial involves clinician-administered therapy sessions rather than medication, traditional side effects are not applicable. However, participants may experience emotional discomfort or distress during or after the sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately prior to intervention, and again at 1 and 3 months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately prior to intervention, and again at 1 and 3 months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hamilton-Anxiety Rating Scale
Hamilton-Depression Rating Scale
Montgomery-Asberg Depression Rating Scale
Secondary outcome measures
DASS
GAD-7
PHQ-8
Other outcome measures
DERS-18
ERQ
IIP-32
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized InterventionExperimental Treatment1 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.
Group II: Non-personalized InterventionActive Control1 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.
Find a Location
Who is running the clinical trial?
Bar-Ilan University, IsraelLead Sponsor
42 Previous Clinical Trials
18,708 Total Patients Enrolled
University of California, BerkeleyOTHER
181 Previous Clinical Trials
720,916 Total Patients Enrolled
United States - Israel Binational Science FoundationOTHER
3 Previous Clinical Trials
1,800 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My PTSD is moderate or severe.My depression is severe or worse.My anxiety is severe or worse.My social anxiety is severe or worse.I have severe separation anxiety.I have been diagnosed with anorexia.I have not experienced hallucinations or delusions.My somatic symptom disorder is severe or worse.My panic disorder is moderate or severe.My agoraphobia is moderate or severe.My anxiety about having a serious illness is severe.My premenstrual symptoms are moderate to severe.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized Intervention
- Group 2: Non-personalized Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment slots for this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this medical study, which was established on the 8th of January 2023, is actively recruiting participants. 240 individuals are anticipated to take part in the trial at 2 locations."
Answered by AI
What is the maximum enrollment capacity for this clinical trial?
"Affirmative, the information available on clinicaltrials.gov shows that this investigation is presently in need of participants. It was initially announced on August 1st 2023 and most recently revised on July 18th 2023, with 240 patients sought from two separate sites."
Answered by AI
Who else is applying?
What site did they apply to?
University of California, Berkeley
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I have mild cognitive impairment and willing to be a test case. I have tried 3 medications and they have not helped, the side effects were worse than the depression. I am determined to heal and interested in your study because it will offer at least one deep counseling session.
PatientReceived 2+ prior treatments
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