Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2014-09-30
2016-10-20
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Interactive Media-Based Problems Solving Treatment
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
No interventions assigned to this group
Interventions
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Interactive Media-Based Problems Solving Treatment
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
80 Years
ALL
No
Sponsors
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Harvard University
OTHER
William Stone
OTHER
Responsible Party
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William Stone
Assistant Professor
Principal Investigators
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William Stone, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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2013P000384
Identifier Type: -
Identifier Source: org_study_id
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