Anxiety DisordersNCT03390218
TAO Outpatient Trial for Anxiety and Depression
A study testing Therapy Assistance Online and Treatment as usual in people with Anxiety Disorders and Depression, run by TAO Connect, Inc. at 1 site in United States.
Trial summary
Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This study will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- Therapy Assistance Online and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to Dec 2018
- 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
- Clients in their first month of treatment with any primary or secondary diagnosis of depression or anxiety. This includes all forms of depression and/or anxiety disorder.
Who cannot join
- Chronic depression with a Likely Utilization of Services Instrument (LUSI) designation of "high" or "consistent user" of services. These clients should be referred to Illness Management Recovery.
- Clients with schizophrenia, or any other form of active psychosis.
- Clients with substance dependence disorder.
- Clients with personality disorders.
- Clients whose intellectual functioning would prevent understanding the TAO system and materials.
- Client must not have been in treatment for anxiety and depression in the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Treatment for Anxiety and Depression Augmented With TAO to Treatment as Usual (TAU) in the Weber Human Services
Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This study will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.
Read the detailed description
Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This stud will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.
TAO group TAO is a suite of tools for providing patient education, support, and accountability delivered digitally. Educational materials are organized in an evidence based-protocolled treatment for anxiety or depression. TAO participants will attend a once weekly group in a computer lab. Each participant will complete an interactive educational module and have a brief session with the group leader to discuss application of the content. Participants will have access to a companion app they may use between sessions to practice skills and reinforce learning.
Treatment as Usual Group - After the completion of a psychosocial assessment, and development of a treatment plan, clients are offered individual and group therapy sessions, case management services, and medication management services depending on the diagnoses. Individual and group therapy is often generic in nature as well, although some structured, evidence-based treatments are offered such as Psycho-Education Multi-Family Group and Illness Management Recovery.
Potential participants will receive an initial evaluation and screening to determine diagnosis, appropriateness for the study, and level of care required. Informed consent will include a statement indicating that agreement to participate will not affect access to treatment. Those who do not wish to participate will receive care as usual. Patients who agree to participate will be randomly assigned to either treatment as usual or treatment augmented with TAO.
Referral and Randomization Process -
- Therapist identifies a client who meets the inclusionary criteria.
- Clinician explains the availability of the TAO support services and the current study and invites the client to participate.
- If the client agrees to participate, the clinician will explain the study and have the client sign the consent to participate form and call customer care to determine if the client will be in the experimental group (A) or control group (B).
- If client is assigned to the experimental group, the clinician will help the client select a time to participate in the TAO support services each week. The clinician will again explain the benefits of participation, seek a commitment to attend, and help resolve any ambivalence of the client to participate.
- If client is assigned to treatment as usual, the clinician will help the client select a time to participate in group session.
- The referring clinician will then email the group therapist to inform him/her of the referral.
Introducing the TAO Support Services to Potential Clients -
- Ask permission to share information about the TAO Support Services
- Explain that the TAO system provides mental health services through an electronic system completed on a computer. Clients watch videos and complete modules on a computer for approximately 45 minutes to an hour, one time each week for 8 weeks.
- Explain that participation in these support services has been shown in other studies to reduce symptoms, and that a current study is underway to determine if this will prove helpful to clients at WHS.
- Invite the client to participate in the study letting him/her know that agreeing to participate in the study does not guarantee access to the TAO system.
- If client agrees -
- Have client sign the consent to participate form.
- Contact customer care to find out if the client is assigned to the TAO system or the control group.
- If assigned to the TAO system, help the client know when and where to meet for the TAO session. Contact the group leader with client information.
Measures
Participants in both the experimental group (TAO) and the control group treatment as usual (TAU) will complete the OQ-45 at intake, and in each subsequent session. TAO participants will also complete the Behavioral Health Measure-20 just prior to each group session on the computer in the computer lab.
Participants in both the experimental group (TAO) and the control group (TAU) will complete the OQ-45 at intake and at each group session. WE Well-being scale.
Sessions completed. Demographics.
Subjects
Subjects will be clients seeking treatment for anxiety and depression at Weber Human Services. All participants will be adults (18 and over) who meet inclusion criteria. Clients who agree to participant will be randomly assigned to a treatment condition. We will enroll fifty clients per treatment condition and enrollment will be ongoing until the number is reached. Active treatment will be 8 weeks, with follow-up at 3 months. Participants will not receive renumeration for participation.
Researchers at (TAO Connect, Inc.) TCI will have no direct contact with the subjects. All data collection will occur through the computer system. TCI technical support staff will have minimal PHI: name, login, email address if the client requires any technical support.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- Therapy Assistance Online, Treatment as usual
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy Assistance OnlineBehavioural
protocoled on-line educational modules, with brief therapist interaction and practice support with a mobile app.
Treatment as usualBehavioural
Individual and group therapy, generic in nature
| Study group | Role | What they receive |
|---|---|---|
| TAO (Therapy Assisted Online) | Experimental | TAO participants will attend a once weekly group in a computer lab. Each participant will complete an interactive educational module using an evidence based protocoled treatment for anxiety and/or depression, and have a brief session with the group leader to discuss application of the content. Participants will have access to a companion app they may use between sessions to practice skills and reinforce learning. Receives: Behavioral: Therapy Assistance Online |
| Treatment as usual | Active comparator | After the completion of a psychosocial assessment, and development of a treatment plan, clients are offered individual and group therapy sessions, case management services, and medication management services depending on the diagnoses. Individual and group therapy is often generic in nature as well, although some structured, evidence-based treatments are offered such as Psycho-Education Multi-Family Group and Illness Management Recovery. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Questionnaire-45
45 question survey, assessing symptom change, the OQ-45 is the most commonly used measure of change in psychotherapy. The OQ-45 has one general scale and 3 sub-scales.
- The symptom distress scale scores range from 0-100 with a clinical cut-off of 36. Reliable change is indicated when a client's score changes by 10 points or more.
- The Interpersonal relations scale scores range from 0-44, the clinical cut-off is 15, reliable change when a client's score changes by 8 points or more.
- Social role scale, scores range from 0-36, clinical cut-off is 12 or more, reliable change is a change of 7 points or more
Measured: At intake, 8 weeks, 12 weeks- change in scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start15 Jan 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TAO Connect, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sherry Benton, TAO Connect, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390218
- Sponsor's protocol ID
- TAO001
- Status last verified
- Jan 2018
- First submitted
- 27 Nov 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing individual participant data in behavioral health is prohibited by law.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment for Anxiety and Depression Augmented With TAO to Treatment as Usual (TAU) in the Weber Human Services
- ClinicalTrials.gov ID
- NCT03390218
- Acronym / sponsor ID
- TAO001
- Conditions
- Anxiety Disorders, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- TAO Connect, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Jan 2018 (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.
Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This study will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.
Detailed description
Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This stud will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.
TAO group TAO is a suite of tools for providing patient education, support, and accountability delivered digitally. Educational materials are organized in an evidence based-protocolled treatment for anxiety or depression. TAO participants will attend a once weekly group in a computer lab. Each participant will complete an interactive educational module and have a brief session with the group leader to discuss application of the content. Participants will have access to a companion app they may use between sessions to practice skills and reinforce learning.
Treatment as Usual Group - After the completion of a psychosocial assessment, and development of a treatment plan, clients are offered individual and group therapy sessions, case management services, and medication management services depending on the diagnoses. Individual and group therapy is often generic in nature as well, although some structured, evidence-based treatments are offered such as Psycho-Education Multi-Family Group and Illness Management Recovery.
Potential participants will receive an initial evaluation and screening to determine diagnosis, appropriateness for the study, and level of care required. Informed consent will include a statement indicating that agreement to participate will not affect access to treatment. Those who do not wish to participate will receive care as usual. Patients who agree to participate will be randomly assigned to either treatment as usual or treatment augmented with TAO.
Referral and Randomization Process -
- Therapist identifies a client who meets the inclusionary criteria.
- Clinician explains the availability of the TAO support services and the current study and invites the client to participate.
- If the client agrees to participate, the clinician will explain the study and have the client sign the consent to participate form and call customer care to determine if the client will be in the experimental group (A) or control group (B).
- If client is assigned to the experimental group, the clinician will help the client select a time to participate in the TAO support services each week. The clinician will again explain the benefits of participation, seek a commitment to attend, and help resolve any ambivalence of the client to participate.
- If client is assigned to treatment as usual, the clinician will help the client select a time to participate in group session.
- The referring clinician will then email the group therapist to inform him/her of the referral.
Introducing the TAO Support Services to Potential Clients -
- Ask permission to share information about the TAO Support Services
- Explain that the TAO system provides mental health services through an electronic system completed on a computer. Clients watch videos and complete modules on a computer for approximately 45 minutes to an hour, one time each week for 8 weeks.
- Explain that participation in these support services has been shown in other studies to reduce symptoms, and that a current study is underway to determine if this will prove helpful to clients at WHS.
- Invite the client to participate in the study letting him/her know that agreeing to participate in the study does not guarantee access to the TAO system.
- If client agrees -
- Have client sign the consent to participate form.
- Contact customer care to find out if the client is assigned to the TAO system or the control group.
- If assigned to the TAO system, help the client know when and where to meet for the TAO session. Contact the group leader with client information.
Measures
Participants in both the experimental group (TAO) and the control group treatment as usual (TAU) will complete the OQ-45 at intake, and in each subsequent session. TAO participants will also complete the Behavioral Health Measure-20 just prior to each group session on the computer in the computer lab.
Participants in both the experimental group (TAO) and the control group (TAU) will complete the OQ-45 at intake and at each group session. WE Well-being scale.
Sessions completed. Demographics.
Subjects
Subjects will be clients seeking treatment for anxiety and depression at Weber Human Services. All participants will be adults (18 and over) who meet inclusion criteria. Clients who agree to participant will be randomly assigned to a treatment condition. We will enroll fifty clients per treatment condition and enrollment will be ongoing until the number is reached. Active treatment will be 8 weeks, with follow-up at 3 months. Participants will not receive renumeration for participation.
Researchers at (TAO Connect, Inc.) TCI will have no direct contact with the subjects. All data collection will occur through the computer system. TCI technical support staff will have minimal PHI: name, login, email address if the client requires any technical support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| TAO (Therapy Assisted Online) | Experimental | Behavioral: Therapy Assistance OnlineTAO participants will attend a once weekly group in a computer lab. Each participant will complete an interactive educational module using an evidence based protocoled treatment for anxiety and/or depression, and have a brief session with the group leader to discuss application of the content. Participants will have access to a companion app they may use between sessions to practice skills and reinforce learning. |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualAfter the completion of a psychosocial assessment, and development of a treatment plan, clients are offered individual and group therapy sessions, case management services, and medication management services depending on the diagnoses. Individual and group therapy is often generic in nature as well, although some structured, evidence-based treatments are offered such as Psycho-Education Multi-Family Group and Illness Management Recovery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clients in their first month of treatment with any primary or secondary diagnosis of depression or anxiety. This includes all forms of depression and/or anxiety disorder.
Key exclusion criteria (6 listed)
- Chronic depression with a Likely Utilization of Services Instrument (LUSI) designation of "high" or "consistent user" of services. These clients should be referred to Illness Management Recovery.
- Clients with schizophrenia, or any other form of active psychosis.
- Clients with substance dependence disorder.
- Clients with personality disorders.
- Clients whose intellectual functioning would prevent understanding the TAO system and materials.
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 |
|---|---|---|
| Therapy Assistance Onlineprotocoled on-line educational modules, with brief therapist interaction and practice support with a mobile app. | Behavioural | TAO (Therapy Assisted Online) |
| Treatment as usualIndividual and group therapy, generic in nature | Behavioural | Treatment as usual |
Primary outcome
Outcome Questionnaire-45
Time frame: At intake, 8 weeks, 12 weeks- change in scores
45 question survey, assessing symptom change, the OQ-45 is the most commonly used measure of change in psychotherapy. The OQ-45 has one general scale and 3 sub-scales. 1. The symptom distress scale scores range from 0-100 with a clinical cut-off of 36. Reliable change is indicated when a client's score changes by 10 points or more. 2. The Interpersonal relations scale scores range from 0-44, the clinical cut-off is 15, reliable change when a client's score changes by 8 points or more. 3. Social role scale, scores range from 0-36, clinical cut-off is 12 or more, reliable change is a change of 7 points or more
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Individual participant dataSharing planned: No. Sharing individual participant data in behavioral health is prohibited by law.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy Assistance Online and Treatment as usual in people with Anxiety Disorders and Depression, run by TAO Connect, Inc. 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 1 inclusion and 6 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 4 Jan 2018. 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?
Results are not available in the source record.
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?
Outcome Questionnaire-45 (time frame: At intake, 8 weeks, 12 weeks- change in scores). 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 4 Jan 2018.