NCT00879255

Brief Summary

The immediate objective of this project was to evaluate the clinical effectiveness of a telemental health modality (video-teleconferencing) for providing an evidence-based group intervention (Cognitive Processing Therapy; CPT) to rural OIF/OEF Reservists, National Guardsmen, and veterans suffering with PTSD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_3

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

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 2, 2015

Completed
Last Updated

May 12, 2015

Status Verified

April 1, 2015

Enrollment Period

4.9 years

First QC Date

April 7, 2009

Results QC Date

November 12, 2014

Last Update Submit

April 23, 2015

Conditions

Posttraumatic Stress Disorder

Keywords

cognitive processing therapycombatveteransPTSDTelemental HealthVideoteleconferenceoutcomeRuralRemoteCPTVTC

Outcome Measures

Primary Outcomes (3)

  • Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)

    The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. post-treatment CAPS score assessed at two-weeks following end of treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.

    Post-treatment (two-weeks following end of treatment)

  • Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)

    The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 3-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improvement) over time.

    3-month Post-treatment

  • Clinician Administered PTSD Scale, for DSM-IV (CAPS IV)

    The CAPS is a 30-item interview measure that assesses the frequency and intensity of PTSD symptoms during the past month and the impact these symptoms have had on social and occupational functioning. The CAPS also provides a global scale score of PTSD severity (range 0 - 136) with higher scores indicating worse symptoms, which was used as the primary outcome measure. Scores reported here are differences between individuals follow up scores (e.g. 6-month post-treatment) minus their baseline CAPS scores, such that negative numbers represent reductions in CAPS scores (or improve) over time.

    6 months post-treatment

Study Arms (2)

Videoteleconferencing CPT

EXPERIMENTAL

The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality. Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.

Behavioral: Cognitive Processing Therapy Group Videoteleconference

Face-to-Face CPT

ACTIVE COMPARATOR

The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality. Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.

Behavioral: Cognitive Processing Therapy Group In-Person

Interventions

Cognitive Processing Therapy Group VideoteleconferenceBEHAVIORAL

Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.

Also known as: CPT-VT
Videoteleconferencing CPT
Cognitive Processing Therapy Group In-PersonBEHAVIORAL

Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.

Also known as: CPT-NP
Face-to-Face CPT

Eligibility Criteria

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

You may qualify if:

  • diagnosis of current combat related PTSD determined by the Clinician Administered PSTD Scale (CAPS-IV)
  • participants taking psychoactive medications have to have a stable regimen for at least 45 days prior to study entry

You may not qualify if:

  • active psychotic symptoms/disorder as determined by the SCID for DSM-IV
  • active homicidal or suicidal ideation as determined by the structured clinical interview
  • any significant cognitive impairment or history of Organic Mental Disorder as determined by the structured clinical interview
  • active (current) substance dependence as determined by the SCID (lifetime substance dependence/abuse not excluded)
  • unwillingness to refrain from substance abuse during treatment
  • female veterans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pacific Islands Health Care System, Honolulu, HI

Honolulu, Hawaii, 96819-1522, United States

Location

Related Publications (6)

  • Morland LA, Greene CJ, Rosen C, Mauldin PD, Frueh BC. Issues in the design of a randomized noninferiority clinical trial of telemental health psychotherapy for rural combat veterans with PTSD. Contemp Clin Trials. 2009 Nov;30(6):513-22. doi: 10.1016/j.cct.2009.06.006. Epub 2009 Jul 1.

    PMID: 19576299RESULT

  • Morland LA, Hynes AK, Mackintosh MA, Resick PA, Chard KM. Group cognitive processing therapy delivered to veterans via telehealth: a pilot cohort. J Trauma Stress. 2011 Aug;24(4):465-9. doi: 10.1002/jts.20661. Epub 2011 Jul 25.

    PMID: 21793047RESULT

  • Morland LA, Mackintosh MA, Greene CJ, Rosen CS, Chard KM, Resick P, Frueh BC. Cognitive processing therapy for posttraumatic stress disorder delivered to rural veterans via telemental health: a randomized noninferiority clinical trial. J Clin Psychiatry. 2014 May;75(5):470-6. doi: 10.4088/JCP.13m08842.

    PMID: 24922484RESULT

  • Glassman LH, Mackintosh MA, Wells SY, Wickramasinghe I, Walter KH, Morland LA. Predictors of Quality of Life Following Cognitive Processing Therapy Among Women and Men With Post-Traumatic Stress Disorder. Mil Med. 2020 Jun 8;185(5-6):e579-e585. doi: 10.1093/milmed/usz474.

    PMID: 32077948DERIVED

  • Raab PA, Mackintosh MA, Gros DF, Morland LA. Examination of the Content Specificity of Posttraumatic Cognitions in Combat Veterans With Posttraumatic Stress Disorder. Psychiatry. 2015;78(4):328-40. doi: 10.1080/00332747.2015.1082337.

    PMID: 26745686DERIVED

  • Raab PA, Mackintosh MA, Gros DF, Morland LA. Impact of comorbid depression on quality of life in male combat Veterans with posttraumatic stress disorder. J Rehabil Res Dev. 2015;52(5):563-76. doi: 10.1682/JRRD.2014.05.0130.

    PMID: 26466310DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

For patients in rural areas, their local mental health facilities may not have access to videoteleconferencing technology.There were no women veterans as study participants. Participants with acute safety concerns or current substances were excluded.

Results Point of Contact

Title
Leslie A. Morland, Clinical Psychologist
Organization
Department of Veterans Affairs
leslie.morland@va.gov
(619) 497-8406

Study Officials

  • Leslie A Morland, PsyD

    VA Pacific Islands Health Care System, Honolulu, HI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 9, 2009

Study Start

October 1, 2008

Primary Completion

September 1, 2013

Study Completion

June 1, 2014

Last Updated

May 12, 2015

Results First Posted

March 2, 2015

Record last verified: 2015-04

Locations

US(1)