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A Computerized Intervention for Depression

Primary Purpose

Depression

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Interactive Media-Based Problems Solving Treatment

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Beth Israel Deconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ImbPST

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Self-report measure for symptoms of depression

Secondary Outcome Measures

Software usability will be measured by the System Usability Scale

Self-report measure

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

Full Information

NCT ID

NCT02655588

First Posted

January 5, 2016

Last Updated

March 10, 2017

Sponsor

William Stone

Collaborators

Harvard University

1. Study Identification

Unique Protocol Identification Number

NCT02655588

Brief Title

A Computerized Intervention for Depression

Official Title

A Computerized Intervention for Depression

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

October 20, 2016 (Actual)

Study Completion Date

October 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

William Stone

Collaborators

Harvard University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ImbPST

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Interactive Media-Based Problems Solving Treatment

Primary Outcome Measure Information:

Title

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

Description

Self-report measure for symptoms of depression

Time Frame

Within the first 9 weeks after initiating treatment.

Secondary Outcome Measure Information:

Title

Software usability will be measured by the System Usability Scale

Description

Self-report measure

Time Frame

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

Title

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

Description

Self-report measure for symptoms of depression

Time Frame

Within the first 9 weeks after initiating treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Stone, Ph.D.

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

11315728

Citation

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.

Results Reference

background

Citation

Hegel, M.T., & Arean, P.A. (2003) Problem-solving Treatment for Primary Care (PST-PC): A Treatment Manual for Depression

Results Reference

background

PubMed Identifier

20192789

Citation

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.

Results Reference

background

PubMed Identifier

12622301

Citation

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.

Results Reference

background

PubMed Identifier

11556941

Citation

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.

Results Reference

background

PubMed Identifier

16356311

Citation

Heinzelmann PJ, Lugn NE, Kvedar JC. Telemedicine in the future. J Telemed Telecare. 2005;11(8):384-90. doi: 10.1177/1357633X0501100802.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

162184

Citation

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.

Results Reference

background

PubMed Identifier

11887035

Citation

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.

Results Reference

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A Computerized Intervention for Depression

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