Depression and/or Anxiety in the Mild-to-moderate RangeNCT05953779
Personalized Need-focused Single Session Intervention
A study testing Clinician-administered Need-focused Single Session Intervention in people with Depression and/or Anxiety in the Mild-to-moderate Range, run by Bar-Ilan University, Israel at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression and/or Anxiety in the Mild-to-moderate Range
- What is being tested?
- Clinician-administered Need-focused Single Session Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jan 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
Gal Lazarus, PhD contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
University of California, Berkeley
Berkeley, California, 94720
Aaron J. Fisher, PhD, 510-642-8615, afisher@berkeley.edu
Israel1 site, 1 recruiting
- Recruiting
Bar-Ilan University
Ramat Gan, 52900
Eshkol Rafaeli, PhD, +972-3-7384660, eshkol.rafaeli@gmail.com
About this study
Official title: Randomized Controlled Trial for Personalized Need-focused Single-Session Interventions
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.
Read the 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).
- Being tested
- Clinician-administered Need-focused Single Session Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician-administered Need-focused Single Session InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Intervention | Experimental | 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. Receives: Behavioral: Clinician-administered Need-focused Single Session Intervention |
| Non-personalized Intervention | Active comparator | 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. Receives: Behavioral: Clinician-administered Need-focused Single Session Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton-Depression Rating Scale
(Range 0-52, higher scores denote greater depression)
Measured: Change between pre-intervention and 1 month post-intervention
Montgomery-Asberg Depression Rating Scale
(Range 0-60, higher scores denote greater depression)
Measured: Change between pre-intervention and 1 month post-intervention
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.
Measured: Change between pre-intervention and 1 month post-intervention
Secondary outcomes (3)
PHQ-8
(Range 0-24, higher scores denote greater depression)
Measured: Immediately prior to intervention, and again at 1 and 3 months post-intervention
GAD-7
(Range 0-21, higher scores denote greater anxiety)
Measured: Immediately prior to intervention, and again at 1 and 3 months post-intervention
DASS
(Range 0-63, higher scores denote greater depression, anxiety, and stress)
Measured: Immediately prior to intervention, and again at 1 and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start8 Jan 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and/or Anxiety in the Mild-to-moderate RangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, United States - Israel Binational Science Foundation
- Responsible party
- Principal investigator, Prof. Eshkol Rafaeli, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953779
- Sponsor's protocol ID
- ER13323
- Status last verified
- Jul 2023
- First submitted
- 18 Mar 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be made available through the osf.io platform or similar platforms.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Personalized Need-focused Single-Session Interventions
- ClinicalTrials.gov ID
- NCT05953779
- Acronym / sponsor ID
- ER13323
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Collaborators
- University of California, Berkeley, United States - Israel Binational Science Foundation
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Personalized Intervention | Experimental | Behavioral: Clinician-administered Need-focused Single Session InterventionThe 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. |
| Non-personalized Intervention | Active comparator | Behavioral: Clinician-administered Need-focused Single Session InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician-administered Need-focused Single Session InterventionAll 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. | Behavioural | Non-personalized Intervention, Personalized Intervention |
Primary outcome
Hamilton-Depression Rating Scale
Time frame: Change between pre-intervention and 1 month post-intervention
(Range 0-52, higher scores denote greater depression)
Montgomery-Asberg Depression Rating Scale
Time frame: Change between pre-intervention and 1 month post-intervention
(Range 0-60, higher scores denote greater depression)
Hamilton-Anxiety Rating Scale
Time frame: Change between pre-intervention and 1 month post-intervention
(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.
3 secondary outcomes
PHQ-8
Time frame: Immediately prior to intervention, and again at 1 and 3 months post-intervention
GAD-7
Time frame: Immediately prior to intervention, and again at 1 and 3 months post-intervention
DASS
Time frame: Immediately prior to intervention, and again at 1 and 3 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided. De-identified data will be made available through the osf.io platform or similar platforms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gal Lazarus, PhD contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician-administered Need-focused Single Session Intervention in people with Depression and/or Anxiety in the Mild-to-moderate Range, run by Bar-Ilan University, Israel at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eshkol Rafaeli, PhD (+972-3-7384660, eshkol.rafaeli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton-Depression Rating Scale (time frame: Change between pre-intervention and 1 month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.