AnxietyNCT05449002
Digital Single Session Intervention for Youth Mental Health
A study testing Practicing the Opposite (PTO) and Usual Clinical Care in people with Anxiety and Depression, run by Harvard University at 5 sites in United States.
Trial summary
The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition. Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Conduct Disorder
- What is being tested?
- Practicing the Opposite (PTO) and Usual Clinical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Sep 2022to 30 Sep 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth/family has contacted a participating outpatient clinic to seek mental health care, and is placed on the waitlist.
- Youth is between the ages of 9-17 years (inclusive) at the time of study enrollment.
- Youth and at least one guardian consent to the youth's participation in study.
- Youth reads English well enough to effectively complete the digital programs (defined as taking classes in English, as opposed to ESL classes).
- Youth has access to a digital device.
Who cannot join
- Youth is non-English speaking, as the program is only available in English.
- Youth does not have access to a digital device.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Boston Child Study Center
Boston, Massachusetts, 02116
The Baker Center for Children and Families
Boston, Massachusetts, 02120
The Concord Center
Concord, Massachusetts, 01742
Riverside Community Care
Dedham, Massachusetts, 02026
Riley Child Psychiatry and Behavioral Sciences Clinic
Indianapolis, Indiana, 46202
About this study
Official title: Testing a Digital Single-session Intervention for Youths on the Waitlist for Psychotherapy
The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.
Read the detailed description
There is a massive unmet need for youth mental health care in America; only ¼ of youth in need receive services. The problem has been underscored and exacerbated by the pandemic. The need for child and adolescent mental health care, particularly for depression and anxiety, has surged while clinician availability and clinic funding have shrunk. One result is that clinic waitlists, always lengthy, have stretched, with youths and families who seek care waiting for up to 12 months for a first appointment, and many giving up and dropping out before the much-delayed appointment. There is a clear need-in both pandemic and normal times-for efficient mental health support that can be provided when need is acute, to sustain young people through periods of delayed access, and to reduce burden for professionals. Fortunately, recent evidence shows the surprising potential of brief, low-cost, digital interventions that could go a long way toward bridging the need-to-access gap. Single-session interventions have substantial effects, in some cases rivaling effects of full-length in-person psychotherapy. Remote therapies for youth mental health problems are beneficial on average and approximately as beneficial as in-person psychotherapy.
The current trial will test a brief (one 30-45-minute session), online, interactive mental health and behavior change intervention for adolescents (9-17 years old), who have been placed the waitlist for outpatient treatment at participating mental health clinics in the United States. Previous RCTs show beneficial effects of the principle of Practicing the Opposite (PTO) on youth mental health when using the therapeutic elements present in PTO (e.g., exposure, to overcome anxiety; behavioral activation, to overcome depression). The single-session PTO intervention uses stories, interactive activities, and engaging graphics to teach youths a key principle: by practicing the positive opposite of unhelpful behaviors, one can, over time, change their emotions thoughts, and actions.
- Conditions
- Anxiety, Depression, Conduct Disorder, Stress
- Being tested
- Practicing the Opposite (PTO), Usual Clinical Care
- Medical subject headings
- Anxiety Disorders, Depression, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practicing the Opposite (PTO)Behavioural
This 30-45-minute digital program is designed to help youths on the waitlist feel better prior to treatment and may also improve their treatment engagement and outcomes.
Usual Clinical CareOther
Usual care provided by participating youth mental health clinics in the United States.
| Study group | Role | What they receive |
|---|---|---|
| Practicing the Opposite (PTO) intervention | Experimental | This 30-45 minutes Qualtrics-based, digital program uses stories, interactive activities, and engaging graphics to teach youths one core principle: by practicing the positive opposite of unhelpful behaviors (e.g., engaging with rather than avoiding feared stimuli), one can, over time, change their mood, thoughts, and actions. The intervention is comprised of four main sections: 1) An introduction to PTO; (2) Testimonials from young people who have been helped by PTO; (3) Learning how to Practice the Opposite through online activities. (4) Planning how to continue to Practice the Opposite in the participant's life. Of note, after being removed from the waitlist at the clinic and contacted to begin treatment, participants will still receive treatment as usual from the clinic. Receives: Behavioral: Practicing the Opposite (PTO) |
| Usual waitlist control group | Other | Usual waitlist procedures involve watchful waiting for a therapist to become available, sometimes complemented by periodic check-ins from the family with clinic administrators. After being removed from the waitlist and contacted to begin treatment, participants in both study conditions will receive treatment as usual in the clinic. Receives: Other: Usual Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior and Feelings Survey (Youth and Parent Versions)
Assesses the child's thoughts and feelings over the past week using both youth and parent report. Both the youth and parent report surveys include 12 items each scored from 04, with higher scores indicating more severe symptoms. Consists of an internalizing and externalizing subscale, the trajectories of which will be analyzed separately and compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Measured: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
Generalized Anxiety Disorder 7-item scale (GAD-7)
Assesses via a 7-item youth self-report questionnaire (in which scores range from 0-21, and higher scores indicate more severe symptoms) the youth's experience of anxiety symptoms. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Measured: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
Patient Health Questionnaire 8-item scale (PHQ-8)
Assesses via an 8-item youth self-report questionnaire (in which scores range from 0-24, and higher scores indicate more severe symptoms) the youth's experience of anxiety symptoms. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Measured: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
Revised Children's Anxiety and Depression Scale (RCADS) Parent Version (Short Form)
Trajectory of change on this 24-item parent-report measure of anxiety and depression (in which scores range from 0-72 and higher scores indicate more severe symptoms) will be compared between the intervention and control group. Trajectories of change on the subscales within this measure (broad anxiety and depression) may also be analyzed similarly. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Measured: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
Secondary outcomes (5)
Ecological Momentary Assessment (EMA) Survey
Consisting of a modified Positive and Negative Affect Scale (PANAS) and a modified Coping Questionnaire, this 8-item measure is administered 3 times daily via an EMA mobile application called Metricwire. It assesses affect and behaviors via youth self-report.
Measured: Scores on each item will be compared across 1 week before the PTO intervention and 2-weeks after. The association between change in behaviors and change in affect across these time ranges will be assessed.
State Hope Scale
Assesses the child's current level of hope using a six-item self-report scale, in which each item is scored from 1 to 8, with higher scores indicating greater hope. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Measured: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Perceived Control Scale for Children
Assesses via a 24-item self-report scale the youth's beliefs about their ability to control and change their environment. Total scores range from 0-72, with higher scores indicating greater perceived control. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Measured: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Secondary Control Scale for Children
Assesses via a 20-item self-report scale the youth's beliefs about their ability to control and change their emotions and thoughts. Total scores range from 0-60, with higher scores indicating greater secondary control. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Measured: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Clinic Record Data
For those participants who authorize investigator access to their clinic record data, the investigators will also compare rates of accessing and completing clinic treatment, as well as attendance at sessions, between the intervention and control groups.
Measured: Through study completion, an anticipated average of 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start5 Sep 2022
- Primary completion31 May 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Participants, 9-17 years old, will be: randomized to a 30-45-minute Qualtrics-based, digital program teaching Practicing the Opposite (PTO, followed by psychotherapy) or to the usual care (i.e., usual waitlist procedures, followed by psychotherapy) control.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Venturo-Conerly, Harvard University
- Investigators
- Katherine Venturo-Conerly, A.B., Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449002
- Sponsor's protocol ID
- IRB22-0101
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Digital Single-session Intervention for Youths on the Waitlist for Psychotherapy
- ClinicalTrials.gov ID
- NCT05449002
- Acronym / sponsor ID
- IRB22-0101
- Conditions
- Anxiety, Depression, Conduct Disorder, Stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Jul 2022 (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.
The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.
Detailed description
There is a massive unmet need for youth mental health care in America; only ¼ of youth in need receive services. The problem has been underscored and exacerbated by the pandemic. The need for child and adolescent mental health care, particularly for depression and anxiety, has surged while clinician availability and clinic funding have shrunk. One result is that clinic waitlists, always lengthy, have stretched, with youths and families who seek care waiting for up to 12 months for a first appointment, and many giving up and dropping out before the much-delayed appointment. There is a clear need-in both pandemic and normal times-for efficient mental health support that can be provided when need is acute, to sustain young people through periods of delayed access, and to reduce burden for professionals. Fortunately, recent evidence shows the surprising potential of brief, low-cost, digital interventions that could go a long way toward bridging the need-to-access gap. Single-session interventions have substantial effects, in some cases rivaling effects of full-length in-person psychotherapy. Remote therapies for youth mental health problems are beneficial on average and approximately as beneficial as in-person psychotherapy.
The current trial will test a brief (one 30-45-minute session), online, interactive mental health and behavior change intervention for adolescents (9-17 years old), who have been placed the waitlist for outpatient treatment at participating mental health clinics in the United States. Previous RCTs show beneficial effects of the principle of Practicing the Opposite (PTO) on youth mental health when using the therapeutic elements present in PTO (e.g., exposure, to overcome anxiety; behavioral activation, to overcome depression). The single-session PTO intervention uses stories, interactive activities, and engaging graphics to teach youths a key principle: by practicing the positive opposite of unhelpful behaviors, one can, over time, change their emotions thoughts, and actions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants, 9-17 years old, will be: randomized to a 30-45-minute Qualtrics-based, digital program teaching Practicing the Opposite (PTO, followed by psychotherapy) or to the usual care (i.e., usual waitlist procedures, followed by psychotherapy) control.
| Arm | Type | Receives |
|---|---|---|
| Practicing the Opposite (PTO) intervention | Experimental | Behavioral: Practicing the Opposite (PTO)This 30-45 minutes Qualtrics-based, digital program uses stories, interactive activities, and engaging graphics to teach youths one core principle: by practicing the positive opposite of unhelpful behaviors (e.g., engaging with rather than avoiding feared stimuli), one can, over time, change their mood, thoughts, and actions. The intervention is comprised of four main sections: 1) An introduction to PTO; (2) Testimonials from young people who have been helped by PTO; (3) Learning how to Practice the Opposite through online activities. (4) Planning how to continue to Practice the Opposite in the participant's life. Of note, after being removed from the waitlist at the clinic and contacted to begin treatment, participants will still receive treatment as usual from the clinic. |
| Usual waitlist control group | Other | Other: Usual Clinical CareUsual waitlist procedures involve watchful waiting for a therapist to become available, sometimes complemented by periodic check-ins from the family with clinic administrators. After being removed from the waitlist and contacted to begin treatment, participants in both study conditions will receive treatment as usual in the clinic. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Youth/family has contacted a participating outpatient clinic to seek mental health care, and is placed on the waitlist.
- Youth is between the ages of 9-17 years (inclusive) at the time of study enrollment.
- Youth and at least one guardian consent to the youth's participation in study.
- Youth reads English well enough to effectively complete the digital programs (defined as taking classes in English, as opposed to ESL classes).
- Youth has access to a digital device.
Key exclusion criteria (2 listed)
- Youth is non-English speaking, as the program is only available in English.
- Youth does not have access to a digital device.
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 |
|---|---|---|
| Practicing the Opposite (PTO)This 30-45-minute digital program is designed to help youths on the waitlist feel better prior to treatment and may also improve their treatment engagement and outcomes. | Behavioural | Practicing the Opposite (PTO) intervention |
| Usual Clinical CareUsual care provided by participating youth mental health clinics in the United States. | Other | Usual waitlist control group |
Primary outcome
Behavior and Feelings Survey (Youth and Parent Versions)
Time frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
Assesses the child's thoughts and feelings over the past week using both youth and parent report. Both the youth and parent report surveys include 12 items each scored from 04, with higher scores indicating more severe symptoms. Consists of an internalizing and externalizing subscale, the trajectories of which will be analyzed separately and compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
Assesses via a 7-item youth self-report questionnaire (in which scores range from 0-21, and higher scores indicate more severe symptoms) the youth's experience of anxiety symptoms. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Patient Health Questionnaire 8-item scale (PHQ-8)
Time frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
Assesses via an 8-item youth self-report questionnaire (in which scores range from 0-24, and higher scores indicate more severe symptoms) the youth's experience of anxiety symptoms. Trajectory of change on this measure will be compared between the intervention and control group. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
Revised Children's Anxiety and Depression Scale (RCADS) Parent Version (Short Form)
Time frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.
Trajectory of change on this 24-item parent-report measure of anxiety and depression (in which scores range from 0-72 and higher scores indicate more severe symptoms) will be compared between the intervention and control group. Trajectories of change on the subscales within this measure (broad anxiety and depression) may also be analyzed similarly. Note that timing described below may be adjusted if response or feedback suggests excessive measurement burden.
5 secondary outcomes
Ecological Momentary Assessment (EMA) Survey
Time frame: Scores on each item will be compared across 1 week before the PTO intervention and 2-weeks after. The association between change in behaviors and change in affect across these time ranges will be assessed.
State Hope Scale
Time frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Perceived Control Scale for Children
Time frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Secondary Control Scale for Children
Time frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.
Clinic Record Data
Time frame: Through study completion, an anticipated average of 6-months
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 9 Jun 2026.
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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.
Katherine Venturo-Conerly, A.B. principal investigator
Harvard University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practicing the Opposite (PTO) and Usual Clinical Care in people with Anxiety and Depression, run by Harvard University at 5 sites 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Behavior and Feelings Survey (Youth and Parent Versions) (time frame: Trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and monthly follow-up until completion of clinic treatment or 1 year, whichever comes first.). 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 9 Jun 2026.