A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression

NCT ID: NCT01599585

Last Updated: 2017-06-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-10-31

Brief Summary

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This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person BA treatment for depression.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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In Home

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.

Group Type EXPERIMENTAL

Behavioral Activation

Intervention Type BEHAVIORAL

Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

In-Person

Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth \& Technology.

Group Type ACTIVE_COMPARATOR

Behavioral Activation

Intervention Type BEHAVIORAL

Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Interventions

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Behavioral Activation

Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.

Intervention Type BEHAVIORAL

Other Intervention Names

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BA

Eligibility Criteria

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Inclusion Criteria

* Current Major Depressive or Minor Depressive Disorder
* High-speed internet/network access at home (384kbs minimum)
* Informed consent
* Fluent in the English language

Exclusion Criteria

* Currently undergoing psychotherapy for depression
* less than 18 or greater than 65 year of age
* Active psychotic symptoms/disorders as determined by the SCID for DSM-IV
* Dysthymic Disorder
* Current suicidal ideation with intent or recent (within six months) history of a suicide attempt
* History of Organic Mental Disorder
* Current substance dependence as determined by the SCID (lifetime substance dependence or substance abuse will not be excluded)
* History of violence or poor impulse control causing potential risk to staff or others
* Significant ongoing stressors that require urgent crisis intervention
* Having a living arrangement that will not permit the use of a private space to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role collaborator

National Center for Telehealth and Technology

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory A Gahm, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Telehealth and Technology

David D Luxton, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for Telehealth & Technology

Locations

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Portland VA Medical Center

Portland, Oregon, United States

Site Status

National Center for Telehealth and Technology

Tacoma, Washington, United States

Site Status

Countries

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United States

References

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Reference Type BACKGROUND
PMID: 4147832 (View on PubMed)

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Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.

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Reference Type BACKGROUND
PMID: 3204199 (View on PubMed)

Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.

Reference Type BACKGROUND
PMID: 8991972 (View on PubMed)

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Reference Type BACKGROUND
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Lewinsohn, PM, Biglan, A, Zeiss, AS. Behavioral treatment of depression. The behavioral management of anxiety, depression and pain. (pp.91-46. New York; Bunner/Mazel

Reference Type BACKGROUND

Lewinsohn, PM, Gotlib, IH. Behavioral theory and treatment of depression. In E.E. Beckham and W.R. Leber (Eds). Handbook of depression (pp.352-375) New York: Guildford, 1995

Reference Type BACKGROUND

Jacobson, NS, Martell, CR and Dimidjian, S. Behavioral activation therapy for depression: Returning to contextual roots. Clinical Psychology: Science and Practice 8(3):255-270, 2002

Reference Type BACKGROUND

First, MB, Spitzer RL, Gibbon, M and Williams, JBW. Structured Clinical Interview for DSM-IV Axis Disorders. Arlington, VA: American Psychiatric Press. 2002

Reference Type BACKGROUND

Hopko DR, Lejuez CW, LePage JP, Hopko SD, McNeil DW. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. Behav Modif. 2003 Sep;27(4):458-69. doi: 10.1177/0145445503255489.

Reference Type BACKGROUND
PMID: 12971122 (View on PubMed)

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Reference Type BACKGROUND

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Reference Type BACKGROUND

Mackenzie, CS, Knox, VJ, Gekoski, WL and Macaulay, HL. An adaption and extension of the Attitudes Toward Seeking Professional Psychological Help Scale. Journal of Applied Social Psychology, 34, 2410-2435, 2004.

Reference Type BACKGROUND

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Reference Type BACKGROUND

Luxton DD, Sirotin AP, Mishkind MC. Safety of telemental healthcare delivered to clinically unsupervised settings: a systematic review. Telemed J E Health. 2010 Jul-Aug;16(6):705-11. doi: 10.1089/tmj.2009.0179.

Reference Type BACKGROUND
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Luxton DD, Pruitt LD, O'Brien K, Kramer G. An Evaluation of the Feasibility and Safety of a Home-Based Telemental Health Treatment for Posttraumatic Stress in the U.S. Military. Telemed J E Health. 2015 Nov;21(11):880-6. doi: 10.1089/tmj.2014.0235. Epub 2015 Jun 23.

Reference Type DERIVED
PMID: 26103565 (View on PubMed)

Other Identifiers

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W81XWH-11-2-0118

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

W81XWH-11-2-0118

Identifier Type: -

Identifier Source: org_study_id

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