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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01599585
• Other study ID #: W81XWH-11-2-0118
• Secondary ID: W81XWH-11-2-0118
• Status: Active, not recruiting
• Phase: N/A
• First received: May 11, 2012
• Last updated: September 21, 2016
• Start date: May 2012
• Est. completion date: October 2016

Study information

• Verified date: September 2016
• Source: National Center for Telehealth and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: October 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 pyschotherapy 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Portland VA Medical Center	Portland	Oregon
United States	National Center for Telehealth and Technology	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Telehealth and Technology	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (21)

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

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. — View 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. — View 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. — View Citation

Beck, AT, and Steer RA. Beck Hopelessness Manual. San Antonio, TX: The Psychological Corporation. 1988

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. — View Citation

Cohen, J. Statistical power analysis for the behavioral sciences (2nd ed). Hillsdale, NJ, Lawrence Erlbaum Associates, 1988

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.

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. — View Citation

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

Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Dávila-Román 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. — View 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. — View 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

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. Review. — View 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. — View Citation

Lewinsohn PM, Graf M. Pleasant activities and depression. J Consult Clin Psychol. 1973 Oct;41(2):261-8. — View 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

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

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. Review. — View 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. — View 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.

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Treatment Session Week 1	Yes
Secondary	Structured Clinical Interview for DSM-IV (SCID-IV)	Minor and Major Depressive Disorder and other psychopathology (e.g., Psychotic Disorder) will be assessed with this structured clinical interview based on the DSM-IV. The SCID-IV has excellent inter-rater reliability (overall kappa = 0.85).	Baseline	No
Secondary	PTSD Checklist-Military Version	The PCL is a self-report measure that evaluates all 17 PTSD criteria using a 5-point Likert scale. Sensitivity and specificity are reportedly .82 and .83, respectively for detecting DSM-III R PTSD diagnoses.	Baseline	No
Secondary	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.	Baseline	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self-report measure consisting of 21 items designed to discriminate anxiety from depression. It has high internal consistency (.92) and 1-week test-retest reliability (.75) and discriminates anxious from nonanxious diagnostic groups.	Baseline	No
Secondary	Emotional and Social Loneliness: de Jong Giervald Loneliness Scale	We will assess research participants' emotional and social well-being with the shortened de Jong Gierveld Loneliness Scale. This 6-item scale has been shown to be a reliable and valid measure of overall social and emotional loneliness.	Baseline	No
Secondary	Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)	The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior17: Psychological Openness, Help-seeking Propensity, and Indifference to Stigma. Alpha coefficients for the subscales range from .79 to .82, and internal consistency for the full inventory is .87. Test-retest reliability for the factors ranges from moderate to high. Convergent validity is demonstrated by effectively differentiating those who would and would not use services.	Baseline	No
Secondary	Client Satisfaction Questionnaire	The Client Satisfaction Questionnaire (CSQ) is an 8-item self-report measure of general satisfaction with treatment. Participants are asked to rate variables on a 4-point scale including the kind of service, treatment staff, quality of service, amount, length and quantity of service, outcome of service, general satisfaction, and procedures. The CSQ-8 is scored by summing the individual item scores to produce a range of 8 to 32, with higher scores indicating greater satisfaction. Internal consistency and construct validity have been established and the measure is widely used in research.	Post Treatment - Week 8	No
Secondary	Computer and Audiovisual Technology Questionnaire	Participants will complete a short measure that assesses prior experiences and comfort level with the use of personal computers, the Internet, and audiovisual technology.	Baseline	No
Secondary	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.	Treatment Session Week 2	Yes
Secondary	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.	Treatment Session Week 3	Yes
Secondary	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.	Treatment Session Week 4	Yes
Secondary	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.	Treatment Session Week 5	Yes
Secondary	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.	Treatment Session Week 6	Yes
Secondary	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.	Treatment Session Week 7	Yes
Secondary	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.	Treatment Session Week 8	Yes
Secondary	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.	3 month follow up	Yes
Secondary	Structured Clinical Interview for DSM-IV (SCID-IV)	Minor and Major Depressive Disorder and other psychopathology (e.g., Psychotic Disorder) will be assessed with this structured clinical interview based on the DSM-IV. The SCID-IV has excellent inter-rater reliability (overall kappa = 0.85).	Midpoint - Week 4	No
Secondary	Structured Clinical Interview for DSM-IV (SCID-IV)	Minor and Major Depressive Disorder and other psychopathology (e.g., Psychotic Disorder) will be assessed with this structured clinical interview based on the DSM-IV. The SCID-IV has excellent inter-rater reliability (overall kappa = 0.85).	Post Treatment - Week 8	No
Secondary	Structured Clinical Interview for DSM-IV (SCID-IV)	Minor and Major Depressive Disorder and other psychopathology (e.g., Psychotic Disorder) will be assessed with this structured clinical interview based on the DSM-IV. The SCID-IV has excellent inter-rater reliability (overall kappa = 0.85).	3 month follow up	No
Secondary	PTSD Checklist-Military Version	The PCL is a self-report measure that evaluates all 17 PTSD criteria using a 5-point Likert scale. Sensitivity and specificity are reportedly .82 and .83, respectively for detecting DSM-III R PTSD diagnoses.	Midpoint- Week 4	No
Secondary	PTSD Checklist-Military Version	The PCL is a self-report measure that evaluates all 17 PTSD criteria using a 5-point Likert scale. Sensitivity and specificity are reportedly .82 and .83, respectively for detecting DSM-III R PTSD diagnoses.	Post Treatment- Week 8	No
Secondary	PTSD Checklist-Military Version	The PCL is a self-report measure that evaluates all 17 PTSD criteria using a 5-point Likert scale. Sensitivity and specificity are reportedly .82 and .83, respectively for detecting DSM-III R PTSD diagnoses.	3 month follow up	No
Secondary	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.	Midpoint- Week 4	No
Secondary	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.	Post Treatment- Week 8	No
Secondary	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.	3 month follow up	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self-report measure consisting of 21 items designed to discriminate anxiety from depression. It has high internal consistency (.92) and 1-week test-retest reliability (.75) and discriminates anxious from nonanxious diagnostic groups.	Midpoint- Week 4	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self-report measure consisting of 21 items designed to discriminate anxiety from depression. It has high internal consistency (.92) and 1-week test-retest reliability (.75) and discriminates anxious from nonanxious diagnostic groups.	Post Treatment- Week 8	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self-report measure consisting of 21 items designed to discriminate anxiety from depression. It has high internal consistency (.92) and 1-week test-retest reliability (.75) and discriminates anxious from nonanxious diagnostic groups.	3 month follow up	No
Secondary	Emotional and Social Loneliness: de Jong Giervald Loneliness Scale	We will assess research participants' emotional and social well-being with the shortened de Jong Gierveld Loneliness Scale. This 6-item scale has been shown to be a reliable and valid measure of overall social and emotional loneliness.	Midpoint- Week 4	No
Secondary	Emotional and Social Loneliness: de Jong Giervald Loneliness Scale	We will assess research participants' emotional and social well-being with the shortened de Jong Gierveld Loneliness Scale. This 6-item scale has been shown to be a reliable and valid measure of overall social and emotional loneliness.	Post Treatment- Week 8	No
Secondary	Emotional and Social Loneliness: de Jong Giervald Loneliness Scale	We will assess research participants' emotional and social well-being with the shortened de Jong Gierveld Loneliness Scale. This 6-item scale has been shown to be a reliable and valid measure of overall social and emotional loneliness.	3 month follow up	No
Secondary	Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)	The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior17: Psychological Openness, Help-seeking Propensity, and Indifference to Stigma. Alpha coefficients for the subscales range from .79 to .82, and internal consistency for the full inventory is .87. Test-retest reliability for the factors ranges from moderate to high. Convergent validity is demonstrated by effectively differentiating those who would and would not use services.	Post Treatment- Week 8	No
Secondary	Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)	The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior17: Psychological Openness, Help-seeking Propensity, and Indifference to Stigma. Alpha coefficients for the subscales range from .79 to .82, and internal consistency for the full inventory is .87. Test-retest reliability for the factors ranges from moderate to high. Convergent validity is demonstrated by effectively differentiating those who would and would not use services.	3 month follow up	No
Secondary	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.	Baseline	No
Secondary	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.	Midpoint- Week 4	No
Secondary	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.	3 month follow up	No

External Links

•   Link to recruitment website