Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas

NCT00223652 | Completed Phase 2 Results

• 1 other identifier: IIR 03-069
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to examine the efficacy of telephone-administered cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by community-based outpatient clinics (CBOCs) in the Veteran's Integrated Service Network (VISN) 21, which serves rural areas in Northern California and (VISN) 12, which serves rural areas surrounding the Hines, IL VA Hospital.

Conditions

Depressive Disorder; Depression

Keywords

Cognitive-Behavioral Therapy; Telephone psychotherapy; Clinical Trial; Primary Care Clinic; Treatment for Depression

Outcome Measures

Primary Outcomes (3)

• Change in Severity of Depression Using Hamilton Depression Rating Scale

  Evaluators administered the Hamilton Depression Rating Scale(Ham-D). Veterans were assessed at baseline,12 weeks, 20 weeks(posttreatment), and 6-month follow-up using the Ham-D. Self-reported depression was measured using the Hamilton Depression Rating Scale(Ham-D). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome Ham-D. Ham-D ranges from 0-52, higher values indicate more severe depression. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression.

  Baseline, 12 weeks, 20 weeks

• Change in Severity of Depression Using the Patient Health Questionnaire-9

  Self-reported depression was measured using the Patient Health Questionnaire-9 (PHQ-9). Data across the three time points (baseline, Week 12, Week 20) were analyzed using a mixed-effects repeated measures model with random subject-specific intercepts for continuous outcome PHQ-9. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score ranges from 0-27, higher values indicate more severe depression.

  Baseline, Week 12, Week 20

• Number of Participants Meeting Criteria for Major Depressive Disorder

  Veterans meeting criteria for major depressive disorder were randomized to receive 16 session of T-CBT over 20 weeks or treatment as usual through the CBOC. Generalized estimating equations models with exchangeable working correlation structure was used for the binary outcome (MDE). A veteran was required to meet diagnostic criteria for severe psychiatric disorder(e.g., psychotic, bipolar, or dementia disorder; post-traumatic stress disorder \[PTSD\] patients were not excluded). DSM-IV diagnosis was assessed using the full Mini International Neuropsychiatric Interview at baseline, whereas the major depressive episode(MDE) module was administered at follow-up.

  Baseline to week 12, and week 20

Secondary Outcomes (3)

• Maintenance of Treatment Effect

  6 month follow-up (week 44)

• Maintenance of Treatment Effect

  6-month post treatment follow-up

• Number of Participants Meeting Criteria for Major Depression Disorder at 6 Month Follow-up

  6-month follow up at week 44 post treatment

Study Arms (2)

Arm 1 - Telephone CBT

EXPERIMENTAL

Telephone cognitive behavioral therapy

Behavioral: Telephone cognitive behavioral therapy

Arm 2 - Treatment as Usual

NO INTERVENTION

Treatment as usual control.

Interventions

Telephone cognitive behavioral therapy BEHAVIORAL

An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.

Arm 1 - Telephone CBT

Eligibility Criteria

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

You may qualify if:

• Has a DSM-IV diagnosis of Major Depressive Disorder as assessed using the MINI
• Has a telephone
• Able to speak and read English
• At least 18 years of age
• Able to give informed consent
• Must be registered at a VA community-based, outpatient clinic (CBOC) at VA Eureka or VA Ukiah or VA Santa Rosa, or VA Manteno, or VA Elgin, or VA La Salle

You may not qualify if:

• Has a hearing, voice or visual impairment that would prevent participation in T-CBT
• Meets criteria for dementia
• Is diagnosed with Psychotic Disorder, Bipolar Disorder, substance abuse with clinical consensus, or current severe PTSD.
• Is currently receiving psychotherapy or planning to receive psychotherapy during the 20-week treatment phase of the study
• Has a history of suicide attempts or is at high risk for suicide.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (3)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141, United States

Location

Related Publications (2)

• Mohr DC, Vella L, Hart S, Heckman T, Simon G. The Effect of Telephone-Administered Psychotherapy on Symptoms of Depression and Attrition: A Meta-Analysis. Clin Psychol (New York). 2008;15(3):243-253. doi: 10.1111/j.1468-2850.2008.00134.x.

  PMID: 21369344 RESULT

• Mohr DC, Carmody T, Erickson L, Jin L, Leader J. Telephone-administered cognitive behavioral therapy for veterans served by community-based outpatient clinics. J Consult Clin Psychol. 2011 Apr;79(2):261-5. doi: 10.1037/a0022395.

  PMID: 21299274 RESULT

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: David C. Mohr
• Organization: Northwestern University

d-mohr@northwestern.edu

312- 503-1403

Study Officials

• David C. Mohr, PhD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: April 24, 2015
• Results First Posted: December 17, 2014

Record last verified: 2014-08

Locations

US (3)