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Completed

NCT Number: NCT01599585

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Portland VA Medical Center, Portland, Oregon, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: BA

Primary outcomes

  1. Beck Hopelessness Scale (BHS)

    Time frame: Post treatment - Week 8

    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 outcomes

  1. Adverse Events

    Time frame: Treatment Session Week 1

    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.

  2. Beck Depression Inventory -II (BDI-II)

    Time frame: Baseline

    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.

  3. Adverse Events

    Time frame: Treatment Session Week 2

    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.

  4. Adverse Events

    Time frame: Treatment Session Week 3

    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.

  5. Adverse Events

    Time frame: Treatment Session Week 4

    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.

  6. Adverse Events

    Time frame: Treatment Session Week 5

    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.

  7. Adverse Events

    Time frame: Treatment Session Week 6

    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.

  8. Adverse Events

    Time frame: Treatment Session Week 7

    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.

  9. Adverse Events

    Time frame: Treatment Session Week 8

    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.

  10. Adverse Events

    Time frame: 3 month follow up

    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.

  11. Beck Depression Inventory -II (BDI-II)

    Time frame: Midpoint- Week 4

    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

  12. Beck Depression Inventory -II (BDI-II)

    Time frame: Post Treatment- Week 8

    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.

  13. Beck Depression Inventory -II (BDI-II)

    Time frame: 3 month follow up

    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.

  14. Beck Hopelessness Scale (BHS)

    Time frame: Baseline

    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.

  15. Beck Hopelessness Scale (BHS)

    Time frame: Midpoint- Week 4

    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.

  16. Beck Hopelessness Scale (BHS)

    Time frame: 3 month follow up

    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.

Sponsors and collaborators

Lead sponsor

National Center for Telehealth and Technology

Fed

Collaborators

  • VA Office of Research and Development

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
May 16, 2012
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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