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OpenTrials
Completed

NCT Number: NCT02655588

A Computerized Intervention for Depression

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deconess Medical Center

Boston, Massachusetts, 02130, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Interactive Media-Based Problems Solving Treatment

Behavioral

Primary outcomes

  1. Symptoms of Depression will be assessed by using the Beck Depression Inventory II

    Time frame: Within the first 9 weeks after initiating treatment.

    Self-report measure for symptoms of depression

Secondary outcomes

  1. Software usability will be measured by the System Usability Scale

    Time frame: at baseline (week 0),and post-treatment ( week 9)

    Self-report measure

  2. Symptoms of Depression will be assessed by using the Hopkins Symptom Checklist 20-item Depression Scale ( Self-report)

    Time frame: Within the first 9 weeks after initiating treatment.

    Self-report measure for symptoms of depression

Sponsors and collaborators

Lead sponsor

William Stone

Other

Collaborators

  • Harvard University

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 14, 2016
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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