A Computerized Intervention for Depression

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to examine how much change in depressive symptoms will be observed in persons who use an electronic Problem Solving Treatment (imbPST) compared to a control group at pre-, mid-point, and post-test assessments.

Detailed Description
-----------------
An interactive multimedia computer-based treatment program was developed to provide an electronic version of problem solving therapy for depression (imbPST). The program was entirely automated and did not require the involvement of a live clinician, even though it was designed to provide a virtual therapy experience that feels more like interacting with a person than with a computer. The imbPST program was built to help individuals who did not have access to traditional therapy due the living conditions or individual preferences (e.g. rural, poor and persons desiring privacy or with significant time constraints). This computer-based treatment of depression offered several advantages. It can be used anywhere without a therapist present, and offered a standardized and consistent therapeutic approach. The aim of this study is to reduce symptoms of depression in subjects through the use of a new, electronic Problem Solving Treatment (imbPST). Adult participants with moderate to severe depression symptoms are randomly assigned to either treatment or a wait-list condition. The Beck Depression Inventory-II was used as the primary outcome measure

Official Title
-----------------
A Computerized Intervention for Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Interactive Media-Based Problems Solving Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years of age or older. Present symptoms from the following criteria based on the Diagnostic & Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR): Major Depressive Episode, Mood Disorder Due to a General Medical Condition and/or Adjustment Disorder with Depressed Mood. Depression must be the primary diagnosis and not occur secondary to any another diagnosis such as Post-Traumatic Stress Disorder (PTSD), social phobia, or complicated bereavement, though comorbid diagnoses (e.g., anxiety disorders and PTSD) will not be exclusionary unless they are primary, except as specified below. Not receiving psychological treatment (e.g., face to face) at the time of the study. Not currently be receiving Problem Solving Treatment in any other context. Not reporting/reported suicidal attempts in the year prior to their participation in the study. Be able to write and speak English according to Rapid Estimate of Adult Literacy in Medicine (REALM test scores) Exclusion Criteria: Current suicidal ideation, history of suicidal attempts or self-injurious behavior at any point during the protocol. Have been diagnosed with schizophrenia, bipolar I disorder, with psychosis, other disorder with psychotic symptoms, and/or brain injuries that includes loss of consciousness > 15 minutes and / post-traumatic amnesia of any duration. Any history of treatment with anti-psychotic medication. A felony conviction. Any current or recent (i.e. within the previous 6 months) substance abuse/dependence diagnosis (other than nicotine or caffeine). Current psychological treatment (e.g., face to face).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ImbPST<br>ImbPST Arm: Participants in this arm will interact with imbPST program which provides a simulated therapy session based on the Problem Solving Treatment-Primary Care (PST-PC) treatment manual used in depression clinical trials . imbPST via a virtual therapist (presented via audio and video) provides programmed instructions on the steps and skills of problem solving, emotional support, and tailored feedback to the user's input. | Behavioral: Interactive Media-Based Problems Solving Treatment<br> <br> |
| No Intervention: Control Group<br>Control Arm: Participants in this group will not receive any treatment for their depression and their depressive symptoms will be monitored for 6 to 9 weeks | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Depression will be assessed by using the Beck Depression Inventory II | Self-report measure for symptoms of depression | Within the first 9 weeks after initiating treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Software usability will be measured by the System Usability Scale | Self-report measure | at baseline (week 0),and post-treatment ( week 9) | 
| Symptoms of Depression will be assessed by using the Hopkins Symptom Checklist 20-item Depression Scale ( Self-report) | Self-report measure for symptoms of depression | Within the first 9 weeks after initiating treatment. |