Clinical Trials Logo
NCT number NCT03390218
Study type Interventional
Source TAO Connect, Inc.
Contact
Status Enrolling by invitation
Phase N/A
Start date January 15, 2018
Completion date December 2018

Clinical 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 comparison group, treatment as usual.


Clinical Trial 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 -

1. Therapist identifies a client who meets the inclusionary criteria.

2. Clinician explains the availability of the TAO support services and the current study and invites the client to participate.

3. 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).

4. 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.

5. If client is assigned to treatment as usual, the clinician will help the client select a time to participate in group session.

6. The referring clinician will then email the group therapist to inform him/her of the referral.

Introducing the TAO Support Services to Potential Clients -

1. Ask permission to share information about the TAO Support Services

2. 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.

3. 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.

4. 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.

5. If client agrees -

1. Have client sign the consent to participate form.

2. Contact customer care to find out if the client is assigned to the TAO system or the control group.

6. 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


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran for Depression in Palliative Care Phase 2/Phase 3
Recruiting NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial N/A
Active, not recruiting NCT03069417 - Support for Perinatal Adherence and Depression N/A
Recruiting NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Enrolling by invitation NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Enrolling by invitation NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT02543983 - Neurobiology of Suicide Phase 2
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Completed NCT01198197 - PET Brain and Whole Body Distribution Studies for Nociceptin/Orphanin FQ Peptide (NOP) Receptor Using [11C]NOP-1A Early Phase 1
Recruiting NCT00024635 - Evaluation of Patients With Mood and Anxiety Disorders and Healthy Volunteers N/A
Not yet recruiting NCT03473054 - Stroke Survivors and Caregivers Using an Online Mindfulness-based Intervention Together
Not yet recruiting NCT03293797 - Ultra-Brief Intervention to Reduce Depressive and Anxious Symptoms N/A
Not yet recruiting NCT03254719 - Care Outcomes for Chiropractic Outpatient Veterans N/A
Recruiting NCT02981381 - Synchronized Transcranial Magnetic Stimulation for PTSD Phase 2
Recruiting NCT02970825 - Move and Feel Good : Effects of Intensive Physical Training on Brain Plasticity, Cognition and Psychological Well-being. N/A
Recruiting NCT02987582 - A Feasibility Study of an Emotion-Focused Mindfulness Group N/A
Recruiting NCT02911597 - Double-Blind, Cross-Over Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD) Phase 1
Recruiting NCT02777112 - The Effects of E-mental Health Program and Job Coaching on the Risk of Major Depression in Canadian Working Men N/A