A Computerized Intervention for Depression

NCT02655588 | Completed DMC

• 1 other identifier: 2013P000384
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Software usability will be measured by the System Usability Scale

  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)

  Within the first 9 weeks after initiating treatment.

Study Arms (2)

ImbPST

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Interactive Media-Based Problems Solving Treatment BEHAVIORAL

ImbPST

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• William Stone: lead
• Harvard University: collaborator

Study Sites (1)

Beth Israel Deconess Medical Center

Boston, Massachusetts, 02130, United States

Location

Related Publications (9)

• 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.

  PMID: 11315728 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 20192789 BACKGROUND

• 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.

  PMID: 12622301 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

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

  PMID: 16356311 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 162184 BACKGROUND

• 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.

  PMID: 11887035 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• William Stone, Ph.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 14, 2016
• Study Start: September 1, 2014
• Primary Completion: October 20, 2016
• Study Completion: October 20, 2016
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

US (1)