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

NCT01599585 | Completed Results DMC

• 1 other identifier: W81XWH-11-2-0118
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Behavioral Activation; Tele-medicine

Outcome Measures

Primary Outcomes (1)

• Beck Hopelessness Scale (BHS)

  The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.

  Post treatment - Week 8

Secondary Outcomes (16)

• Adverse Events

  Treatment Session Week 1

• Beck Depression Inventory -II (BDI-II)

  Baseline

• Adverse Events

  Treatment Session Week 2

• Adverse Events

  Treatment Session Week 3

• Adverse Events

  Treatment Session Week 4

Study Arms (2)

In Home

EXPERIMENTAL

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.

Behavioral: Behavioral Activation

In-Person

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Activation

Interventions

Behavioral Activation 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.

Also known as: BA

In Home; In-Person

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Telehealth and Technology: lead
• VA Office of Research and Development: collaborator

Study Sites (2)

Portland VA Medical Center

Portland, Oregon, 97207, United States

Location

National Center for Telehealth and Technology

Tacoma, Washington, 98431, United States

Location

Related Publications (22)

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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.

  PMID: 26103565 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Larry D. Pruitt, PhD
• Organization: National Center for Telehealth and Technology

larry.d.pruitt21.civ@mail.mil

253-968-2946

Study Officials

• Gregory A Gahm, PhD

  National Center for Telehealth and Technology

  PRINCIPAL INVESTIGATOR

• David D Luxton, PhD

  National Center for Telehealth & Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 16, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: October 1, 2016
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)