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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Interactive Media-Based Problems Solving Treatment

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Beth Israel Deconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be 18 years of age or older.
2. 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.
3. 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.
4. Not receiving psychological treatment (e.g., face to face) at the time of the study.
5. Not currently be receiving Problem Solving Treatment in any other context.
6. Not reporting/reported suicidal attempts in the year prior to their participation in the study.
7. Be able to write and speak English according to Rapid Estimate of Adult Literacy in Medicine (REALM test scores)

Exclusion Criteria:

1. Current suicidal ideation, history of suicidal attempts or self-injurious behavior at any point during the protocol.
2. 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.
3. Any history of treatment with anti-psychotic medication.
4. A felony conviction.
5. Any current or recent (i.e. within the previous 6 months) substance abuse/dependence diagnosis (other than nicotine or caffeine).
6. Current psychological treatment (e.g., face to face).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ImbPST; 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
No Intervention: Control Group; 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.

Collaborators and Investigators

• Sponsor: William Stone
• Collaborators: Harvard University
• Investigators: Principal Investigator: William Stone, Ph.D., Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Arnau RC, Meagher MW, Norris MP, Bramson R. Psychometric evaluation of the Beck Depression Inventory-II with primary care medical patients. Health Psychol. 2001 Mar;20(2):112-9. doi: 10.1037//0278-6133.20.2.112.
• Hegel, M.T., & Arean, P.A. (2003) Problem-solving Treatment for Primary Care (PST-PC): A Treatment Manual for Depression
• Munoz RF, Cuijpers P, Smit F, Barrera AZ, Leykin Y. Prevention of major depression. Annu Rev Clin Psychol. 2010;6:181-212. doi: 10.1146/annurev-clinpsy-033109-132040.
• Proudfoot J, Goldberg D, Mann A, Everitt B, Marks I, Gray JA. Computerized, interactive, multimedia cognitive-behavioural program for anxiety and depression in general practice. Psychol Med. 2003 Feb;33(2):217-27. doi: 10.1017/s0033291702007225.
• Heinzelmann PJ, Lugn NE, Kvedar JC. Telemedicine in the future. J Telemed Telecare. 2005;11(8):384-90. doi: 10.1177/1357633X0501100802.
• Beck, A.T., Steer, R.A., & Garbin, M.C. (1988).Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review
• Lipman RS, Covi L, Shapiro AK. The Hopkins Symptom Checklist (HSCL)--factors derived from the HSCL-90. J Affect Disord. 1979 Mar;1(1):9-24. doi: 10.1016/0165-0327(79)90021-1.
• Thornett AM, Mynors-Wallis LM. Credibility of problem-solving therapy and medication for the treatment of depression among primary care patients. Med Sci Monit. 2002 Mar;8(3):CR193-6.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 20, 2016
• Study Completion (Actual): October 20, 2016

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 2013P000384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED