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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Sponsored by
National Center for Telehealth and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Behavioral Activation, Tele-medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Portland VA Medical Center
  • National Center for Telehealth and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

In Home

In-Person

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
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.
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.
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.

Full Information

First Posted
May 11, 2012
Last Updated
March 28, 2017
Sponsor
National Center for Telehealth and Technology
Collaborators
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01599585
Brief Title
A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression
Official Title
A Randomized Controlled Trial of In-Home Tele-behavioral Health Care Utilizing Behavioral Activation for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Telehealth and Technology
Collaborators
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Behavioral Activation, Tele-medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In Home
Arm Type
Experimental
Arm Description
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.
Arm Title
In-Person
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Other Intervention Name(s)
BA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Hopelessness Scale (BHS)
Description
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.
Time Frame
Post treatment - Week 8
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
Treatment Session Week 1
Title
Beck Depression Inventory -II (BDI-II)
Description
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame
Baseline
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
Treatment Session Week 2
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
Treatment Session Week 3
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
Treatment Session Week 4
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
Treatment Session Week 5
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
Treatment Session Week 6
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
Treatment Session Week 7
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
Treatment Session Week 8
Title
Adverse Events
Description
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Time Frame
3 month follow up
Title
Beck Depression Inventory -II (BDI-II)
Description
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome
Time Frame
Midpoint- Week 4
Title
Beck Depression Inventory -II (BDI-II)
Description
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame
Post Treatment- Week 8
Title
Beck Depression Inventory -II (BDI-II)
Description
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Time Frame
3 month follow up
Title
Beck Hopelessness Scale (BHS)
Description
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.
Time Frame
Baseline
Title
Beck Hopelessness Scale (BHS)
Description
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.
Time Frame
Midpoint- Week 4
Title
Beck Hopelessness Scale (BHS)
Description
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.
Time Frame
3 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Gahm, PhD
Organizational Affiliation
National Center for Telehealth and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David D Luxton, PhD
Organizational Affiliation
National Center for Telehealth & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States
Facility Name
National Center for Telehealth and Technology
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression

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