Anxiety Disorders and SymptomsNCT05821634
Personalizing Treatment Delivery
A study testing Personalized intervention condition: Cognitive behavioral therapy skills in people with Anxiety Disorders and Symptoms and PTSD and Trauma-related Symptoms, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Anxiety and anxiety-related disorders frequently co-occur with alcohol use problems resulting in an enormous humanitarian and economic cost to society. The proposed research will use digital technology to examine person-specific risk factors predicting problematic alcohol use in individuals vulnerable to anxiety and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders and Symptoms, PTSD and Trauma-related Symptoms, Alcohol; Use, Problem; Alcohol Use Disorder
- What is being tested?
- Personalized intervention condition: Cognitive behavioral therapy skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Access to a smart phone
- Between 18 and 65 years
- Clinically significant anxiety or trauma-related symptoms
- Alcohol use problems
- Interest in telehealth counseling
- Anticipated New Jersey or New York residence for the duration of the study
Who cannot join
- Currently receiving individual counseling or counseling at a higher level of care
- Psychiatric medication that is not currently at a stable dose (or is not anticipated to remain at a stable dose for the duration of the study)
- Demonstrated indicators of more intensive or acute care
- Temporary residence within the state of New Jersey or New York or out-of-state residence from the state of New Jersey or New York
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers Robert Wood Johnson Medical School
Piscataway, New Jersey, 08901
About this study
Official title: Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Comorbidity and Treatment
Anxiety and anxiety-related disorders frequently co-occur with alcohol use problems resulting in an enormous humanitarian and economic cost to society. The proposed research will use digital technology to examine person-specific risk factors predicting problematic alcohol use in individuals vulnerable to anxiety and anxiety-related disorders and will use this information to design a personalized intervention for individuals seeking psychological treatment. Results from this research will integrate output from novel and innovative digital technology methods into psychotherapy, advancing research on personalized treatment and prevention efforts.
- Conditions
- Anxiety Disorders and Symptoms, PTSD and Trauma-related Symptoms, Alcohol; Use, Problem; Alcohol Use Disorder
- Being tested
- Personalized intervention condition: Cognitive behavioral therapy skills, Therapeutic control condition: Cognitive behavioral therapy skills, Tracking control condition: Supportive counseling
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized intervention condition: Cognitive behavioral therapy skillsBehavioural
An 11-session cognitive behavioral therapy (CBT) skills based intervention will be delivered to participants randomized to the personalized intervention. Influential constructs will be identified using the person specific digital phenotyping model, targeted using CBT skills, and tracked across sessions.
Therapeutic control condition: Cognitive behavioral therapy skillsBehavioural
Participants randomized to this condition will receive an 11-session CBT skills based treatment targeting a non-personalized construct selected from the person-specific digital phenotyping model.
Tracking control condition: Supportive counselingBehavioural
Participants randomized to this condition will receive 11 supportive counseling sessions that are non-directive in nature (providing support and validation for non-acute weekly stressors). Participants will continue digital phenotyping, controlling for the effect of counseling and digital phenotyping.
| Study group | Role | What they receive |
|---|---|---|
| Personalized intervention condition | Experimental | This experimental condition will test a data-driven, person-specific intervention using CBT skills. Receives: Behavioral: Personalized intervention condition: Cognitive behavioral therapy skills |
| Therapeutic control condition | Active comparator | This control condition will provide an experimental comparison to test the process of personalization. Receives: Behavioral: Therapeutic control condition: Cognitive behavioral therapy skills |
| Tracking control condition | Active comparator | This second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact. Receives: Behavioral: Tracking control condition: Supportive counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol related risk
The Alcohol Use Disorder Identification Test (AUDIT) self-report measure (or similar) will be used to assess changes in alcohol related risk.
Measured: Week 3, Week 15 (approximate)
Change in risk drinking levels
The Daily Drinking Questionnaire (DDQ) self-report measure (or similar) will be used to measure changes in alcohol consumption/risk drinking levels.
Measured: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Change in anxiety or anxiety-related symptom severity
The Overall Anxiety Severity and Impairment Scale (OASIS) self-report measure (or similar) will be used to assess changes in anxiety and anxiety-related symptom severity.
Measured: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Change in psychiatric diagnoses
A diagnostic interview will be used to assess change in psychiatric diagnoses at the beginning and end of participation.
Measured: Week 3, Week 15 (approximate)
Secondary outcomes (4)
Number of sessions attended
The number of sessions completed (up to 11) will be used to measure treatment engagement.
Measured: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Change in therapeutic alliance
The Working Alliance Inventory self-report measure (or similar) will be used to measure changes in working therapeutic alliance.
Measured: Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Patient-rated assessment of progress
Patient-rated improvements in functioning assessed will be assessed at (approximately) weekly intervals.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Clinician-rated improvement in functioning
Clinician-rated improvements in functioning assessed will be assessed at the beginning and end of study participation, as well as at (approximately) weekly intervals.
Measured: Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start21 Oct 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorders and SymptomsStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Marilyn L. Piccirillo, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Marilyn Piccirillo, PhD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821634
- Sponsor's protocol ID
- STUDY00013899
- Other IDs
- 4R00AA029459-03
- Status last verified
- May 2026
- First submitted
- 26 Mar 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Phenotyping of Anxiety and Anxiety-Related Alcohol Comorbidity and Treatment
- ClinicalTrials.gov ID
- NCT05821634
- Acronym / sponsor ID
- STUDY00013899
- Conditions
- Anxiety Disorders and Symptoms, PTSD and Trauma-related Symptoms, Alcohol; Use, Problem; Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 20 Apr 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.
Anxiety and anxiety-related disorders frequently co-occur with alcohol use problems resulting in an enormous humanitarian and economic cost to society. The proposed research will use digital technology to examine person-specific risk factors predicting problematic alcohol use in individuals vulnerable to anxiety and anxiety-related disorders and will use this information to design a personalized intervention for individuals seeking psychological treatment. Results from this research will integrate output from novel and innovative digital technology methods into psychotherapy, advancing research on personalized treatment and prevention efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized intervention condition | Experimental | Behavioral: Personalized intervention condition: Cognitive behavioral therapy skillsThis experimental condition will test a data-driven, person-specific intervention using CBT skills. |
| Therapeutic control condition | Active comparator | Behavioral: Therapeutic control condition: Cognitive behavioral therapy skillsThis control condition will provide an experimental comparison to test the process of personalization. |
| Tracking control condition | Active comparator | Behavioral: Tracking control condition: Supportive counselingThis second control condition will provide an experimental comparison to test the effects of health-related tracking and therapeutic contact. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Access to a smart phone
- Between 18 and 65 years
- Clinically significant anxiety or trauma-related symptoms
- Alcohol use problems
- Interest in telehealth counseling
Key exclusion criteria (4 listed)
- Currently receiving individual counseling or counseling at a higher level of care
- Psychiatric medication that is not currently at a stable dose (or is not anticipated to remain at a stable dose for the duration of the study)
- Demonstrated indicators of more intensive or acute care
- Temporary residence within the state of New Jersey or New York or out-of-state residence from the state of New Jersey or New York
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 |
|---|---|---|
| Personalized intervention condition: Cognitive behavioral therapy skillsAn 11-session cognitive behavioral therapy (CBT) skills based intervention will be delivered to participants randomized to the personalized intervention. Influential constructs will be identified using the person specific digital phenotyping model, targeted using CBT skills, and tracked across sessions. | Behavioural | Personalized intervention condition |
| Therapeutic control condition: Cognitive behavioral therapy skillsParticipants randomized to this condition will receive an 11-session CBT skills based treatment targeting a non-personalized construct selected from the person-specific digital phenotyping model. | Behavioural | Therapeutic control condition |
| Tracking control condition: Supportive counselingParticipants randomized to this condition will receive 11 supportive counseling sessions that are non-directive in nature (providing support and validation for non-acute weekly stressors). Participants will continue digital phenotyping, controlling for the effect of counseling and digital phenotyping. | Behavioural | Tracking control condition |
Primary outcome
Change in alcohol related risk
Time frame: Week 3, Week 15 (approximate)
The Alcohol Use Disorder Identification Test (AUDIT) self-report measure (or similar) will be used to assess changes in alcohol related risk.
Change in risk drinking levels
Time frame: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
The Daily Drinking Questionnaire (DDQ) self-report measure (or similar) will be used to measure changes in alcohol consumption/risk drinking levels.
Change in anxiety or anxiety-related symptom severity
Time frame: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
The Overall Anxiety Severity and Impairment Scale (OASIS) self-report measure (or similar) will be used to assess changes in anxiety and anxiety-related symptom severity.
Change in psychiatric diagnoses
Time frame: Week 3, Week 15 (approximate)
A diagnostic interview will be used to assess change in psychiatric diagnoses at the beginning and end of participation.
4 secondary outcomes
Number of sessions attended
Time frame: Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Change in therapeutic alliance
Time frame: Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Patient-rated assessment of progress
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Clinician-rated improvement in functioning
Time frame: Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Week 13, Week 14, Week 15 (approximate)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Marilyn Piccirillo, PhD principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized intervention condition: Cognitive behavioral therapy skills in people with Anxiety Disorders and Symptoms and PTSD and Trauma-related Symptoms, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alcohol related risk (time frame: Week 3, Week 15 (approximate)). The study lists 4 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 30 Jul 2026.