Personalized Need-focused Single Session Intervention (NCT05953779) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hamilton-Depression Rating Scale
Timeframe: Change between pre-intervention and 1 month post-intervention
2
Montgomery-Asberg Depression Rating Scale
Timeframe: Change between pre-intervention and 1 month post-intervention
3
Hamilton-Anxiety Rating Scale
Timeframe: Change between pre-intervention and 1 month post-intervention