Clinical trial NCT01599585: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Behavioral Activation
Tele-medicine
Lead sponsor: National Center for Telehealth and Technology
Sponsor class: FED
Collaborators: name: VA Office of Research and Development
First posted: 2012-05-16
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Beck Hopelessness Scale (BHS)
timeFrame: Post treatment - Week 8
Secondary outcomes:
measure: Adverse Events
timeFrame: Treatment Session Week 1
measure: Beck Depression Inventory -II (BDI-II)
timeFrame: Baseline
measure: Adverse Events
timeFrame: Treatment Session Week 2
measure: Adverse Events
timeFrame: Treatment Session Week 3
measure: Adverse Events
timeFrame: Treatment Session Week 4
measure: Adverse Events
timeFrame: Treatment Session Week 5
measure: Adverse Events
timeFrame: Treatment Session Week 6
measure: Adverse Events
timeFrame: Treatment Session Week 7
measure: Adverse Events
timeFrame: Treatment Session Week 8
measure: Adverse Events
timeFrame: 3 month follow up
measure: Beck Depression Inventory -II (BDI-II)
timeFrame: Midpoint- Week 4
measure: Beck Depression Inventory -II (BDI-II)
timeFrame: Post Treatment- Week 8
measure: Beck Depression Inventory -II (BDI-II)
timeFrame: 3 month follow up
measure: Beck Hopelessness Scale (BHS)
timeFrame: Baseline
measure: Beck Hopelessness Scale (BHS)
timeFrame: Midpoint- Week 4
measure: Beck Hopelessness Scale (BHS)
timeFrame: 3 month follow up
Other outcomes:
Locations:
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Tacoma
country: United States
facility: National Center for Telehealth and Technology
state: Washington
Study officials:
affiliation: National Center for Telehealth and Technology
name: Gregory A Gahm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Center for Telehealth & Technology
name: David D Luxton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewinsohn PM, Graf M. Pleasant activities and depression. J Consult Clin Psychol. 1973 Oct;41(2):261-8. doi: 10.1037/h0035142. No abstract available.
citation: Egede LE, Frueh CB, Richardson LK, Acierno R, Mauldin PD, Knapp RG, Lejuez C. Rationale and design: telepsychology service delivery for depressed elderly veterans. Trials. 2009 Apr 20;10:22. doi: 10.1186/1745-6215-10-22.
citation: 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.
citation: Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73. doi: 10.1016/0005-7967(96)00033-2.
citation: Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Davila-Roman VG, Steinmeyer BC, Hogue CW Jr. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry. 2009 Apr;66(4):387-96. doi: 10.1001/archgenpsychiatry.2009.7.
citation: Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
citation: Mackenzie CS, Gekoski WL, Knox VJ. Age, gender, and the underutilization of mental health services: the influence of help-seeking attitudes. Aging Ment Health. 2006 Nov;10(6):574-82. doi: 10.1080/13607860600641200.
citation: Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
citation: 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.
citation: King R. Cognitive therapy of depression. Aaon Beck, John Rush, Brian Shaw, Gary Emery. New York: Guilford, 1979. Aust N Z J Psychiatry. 2002 Apr;36(2):272-5. doi: 10.1046/j.1440-1614.2002.t01-4-01015.x. No abstract available.
citation: 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
citation: 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
citation: 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
citation: First, MB, Spitzer RL, Gibbon, M and Williams, JBW. Structured Clinical Interview for DSM-IV Axis Disorders. Arlington, VA: American Psychiatric Press. 2002
citation: 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.
citation: Beck, AT, and Steer RA. Beck Hopelessness Manual. San Antonio, TX: The Psychological Corporation. 1988
citation: deJong Giervelde, J and Van Tilburg, TG. A six-item scale for overall emotional and social loneliness: Confirmative tests on a new survey data. Research on Aging, 28, 582-598, 2006.
citation: 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.
citation: Ajzen, I. From intentions to actions: A theory of planned behavior. In J. Khul and J. Beckman (Eds). Action-control: From cognition to behavior (pp. 11-39) Heidelberg, Springer. 1985
citation: Cohen, J. Statistical power analysis for the behavioral sciences (2nd ed). Hillsdale, NJ, Lawrence Erlbaum Associates, 1988
citation: 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.
citation: 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.