NCT01482806

Brief Summary

Depression and anxiety are common in primary care practice and are associated with substantial reductions in health-related quality of life. This Project will test the comparative effectiveness of two on-line treatments for these conditions provided through the context of a Collaborative Care program: (1) moderated access to a proven-effective computerized cognitive behavioral therapy (CCBT) program; versus (2) moderated access to CCBT plus an Internet support group (CCBT+ISG). The Project will also compare the effectiveness of these treatments to PCPs' "usual care" for these conditions, and evaluate the adoption and maintenance of CCBT+ISG by practices following the conclusion of the trial to provide a greater understanding of how to best scale the delivery of these interventions into a variety of primary care settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for phase_2 depression

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_2 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

3.8 years

First QC Date

November 22, 2011

Last Update Submit

August 3, 2020

Conditions

DepressionGeneralized Anxiety DisorderPanic Disorder

Keywords

DepressionAnxietyPrimary careCognitive Behavioral TherapyInternetSupport groupsTechnology assisted

Outcome Measures

Primary Outcomes (1)

  • SF-12 MCS

    The investigators will assess all study patients' mental health-related quality of life (HRQoL) on the SF-12 MCS via telephone at 6-months follow-up, and we will monitor patients for an additional 6 months to evaluate the durability of our interventions.

    6-Month Follow-up

Secondary Outcomes (6)

  • Hamilton Rating Scale for Depression

    6-Months

  • Hamilton Rating Scale for Anxiety

    6-Months

  • WHO Health and Work Performance Questionnaire

    6-Months

  • Health Services Utilization and Costs

    12-Months

  • Attitudes to Computerized CBT

    6-Months

  • +1 more secondary outcomes

Study Arms (3)

Computerized CBT + Internet Support Group

EXPERIMENTAL

Guided patient access to Beating the Blues plus access to a moderated ISG where patients will be able to communicate confidentially to receive and provide advice and peer-support from other study participants (CCBT+ISG; N=300).

Behavioral: CCBT+ISG/Collaborative Care

Computerized CBT Alone

EXPERIMENTAL

Guided patient access to Beating the Blues, a proven-effective, on-line 8-session CCBT program approved for use in the United Kingdom (CCBT-alone; N=300).

Behavioral: CCBT/Collaborative Care

Usual Care

NO INTERVENTION

Primary care physicians' "usual care" for mood and anxiety disorders (UC; N=100).

Interventions

CCBT+ISG/Collaborative CareBEHAVIORAL

Guided patient access to the Beating the Blues CCBT program plus access to a moderated ISG where patients will be able to communicate confidentially to receive and provide advice and peer-support from other study participants These interventions will be delivered as part of a collaborative care intervention provided in concert with their usual source of primary care. Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference.

Computerized CBT + Internet Support Group
CCBT/Collaborative CareBEHAVIORAL

Guided patient access to the Beating the Blues CCBT program. This interventions will be provided as part of a collaborative care intervention provided in concert with their usual source of primary care. Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference.

Computerized CBT Alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years of age.
  • Current major depression, panic, and/or generalized anxiety disorder on PRIME-MD.
  • At least a moderate level of mood and/or anxiety symptoms (PHQ-9 ≥ 10 or a GAD-7 ≥ 10).
  • Not receiving treatment for a mood or anxiety disorder from a mental health specialist.
  • Has a telephone, e-mail address, and reliable access to the Internet.
  • Stable medical condition and life expectancy greater than one year.

You may not qualify if:

  • Active suicidal ideation or psychotic disorder.
  • History of bipolar disorder.
  • Alcohol dependence or other substance abuse disorder within the past three months.
  • Plans to leave present source of care over the following year.
  • Non-English speaking, illiterate, or having a visual or auditory barrier limiting ability to participate in telephone assessments, interventions, or provide signed, informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (10)

  • Rollman BL, Herbeck Belnap B, Rotondi AJ. Internet support groups for health: ready for the Affordable Care Act. J Gen Intern Med. 2014 Nov;29(11):1436-8. doi: 10.1007/s11606-014-2884-z. No abstract available.

    PMID: 24817281BACKGROUND

  • Herbeck Belnap B, Schulberg HC, He F, Mazumdar S, Reynolds CF 3rd, Rollman BL. Electronic protocol for suicide risk management in research participants. J Psychosom Res. 2015 Apr;78(4):340-5. doi: 10.1016/j.jpsychores.2014.12.012. Epub 2014 Dec 27.

    PMID: 25592159BACKGROUND

  • Jonassaint CR, Gibbs P, Belnap BH, Karp JF, Abebe KK, Rollman BL. Engagement and outcomes for a computerised cognitive-behavioural therapy intervention for anxiety and depression in African Americans. BJPsych Open. 2017 Jan 2;3(1):1-5. doi: 10.1192/bjpo.bp.116.003657. eCollection 2017 Jan.

    PMID: 28058109BACKGROUND

  • Cavanagh K, Herbeck Belnap B, Rothenberger SD, Abebe KZ, Rollman BL. My care manager, my computer therapy and me: The relationship triangle in computerized cognitive behavioural therapy. Internet Interv. 2017 Nov 6;11:11-19. doi: 10.1016/j.invent.2017.10.005. eCollection 2018 Mar.

    PMID: 30135755BACKGROUND

  • Rollman BL, Herbeck Belnap B, Abebe KZ, Spring MB, Rotondi AJ, Rothenberger SD, Karp JF. Effectiveness of Online Collaborative Care for Treating Mood and Anxiety Disorders in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Jan 1;75(1):56-64. doi: 10.1001/jamapsychiatry.2017.3379.

    PMID: 29117275BACKGROUND

  • Geramita EM, Herbeck Belnap B, Abebe KZ, Rothenberger SD, Rotondi AJ, Rollman BL. The Association Between Increased Levels of Patient Engagement With an Internet Support Group and Improved Mental Health Outcomes at 6-Month Follow-Up: Post-Hoc Analyses From a Randomized Controlled Trial. J Med Internet Res. 2018 Jul 17;20(7):e10402. doi: 10.2196/10402.

    PMID: 30021711BACKGROUND

  • Jonassaint CR, Belnap BH, Huang Y, Karp JF, Abebe KZ, Rollman BL. Racial Differences in the Effectiveness of Internet-Delivered Mental Health Care. J Gen Intern Med. 2020 Feb;35(2):490-497. doi: 10.1007/s11606-019-05542-1. Epub 2019 Nov 19.

    PMID: 31745855BACKGROUND

  • Rollman BL, Brent DA. Phonotype: a New Taxonomy for mHealth Research. J Gen Intern Med. 2020 Jun;35(6):1881-1883. doi: 10.1007/s11606-019-05407-7. Epub 2019 Nov 8. No abstract available.

    PMID: 31705476BACKGROUND

  • Rotondi AJ, Belnap BH, Rothenberger S, Feldman R, Hanusa B, Rollman BL. Predictors of Use and Drop Out From a Web-Based Cognitive Behavioral Therapy Program and Health Community for Depression and Anxiety in Primary Care Patients: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2024 Jan 17;11:e52197. doi: 10.2196/52197.

    PMID: 38231552DERIVED

  • Morone NE, Herbeck BB, Huang Y, Abebe KZ, Rollman BL, Jonassaint CR. The Impact of Optimism and Pain Interference on Response to Online Behavioral Treatment for Mood and Anxiety Symptoms. Psychosom Med. 2021 Nov-Dec 01;83(9):1067-1074. doi: 10.1097/PSY.0000000000000980.

    PMID: 34267085DERIVED

Related Links

MeSH Terms

Conditions

DepressionGeneralized Anxiety DisorderPanic DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Bruce L. Rollman, MD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 22, 2011

First Posted

December 1, 2011

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

May 30, 2017

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

US(1)