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Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain (TTCP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01055639
First received: January 21, 2010
Last updated: June 30, 2016
Last verified: June 2015
Results First Received: June 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Pain
Interventions: Behavioral: In-Person ACT
Behavioral: Telehealth ACT

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
In-person ACT

8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.

In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Telehealth ACT

8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.

Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action


Participant Flow:   Overall Study
    In-person ACT   Telehealth ACT
STARTED   66   60 
COMPLETED   45   31 
NOT COMPLETED   21   29 
Adverse Event                0                1 
Lack of Efficacy                0                1 
Lost to Follow-up                8                11 
Protocol Violation                5                5 
Withdrawal by Subject                8                11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
In-person ACT

8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.

In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Telehealth ACT

8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.

Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Total Total of all reporting groups

Baseline Measures
   In-person ACT   Telehealth ACT   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   60   126 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   55   54   109 
>=65 years   11   6   17 
Gender 
[Units: Participants]
     
Female   11   10   21 
Male   55   50   105 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   11   8   19 
Not Hispanic or Latino   55   52   107 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   3   3   6 
Native Hawaiian or Other Pacific Islander   0   3   3 
Black or African American   19   16   35 
White   38   33   71 
More than one race   5   5   10 
Unknown or Not Reported   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brief Pain Inventory-interference Subscale   [ Time Frame: 8 weeks ]

2.  Secondary:   Brief Pain Inventory-severity Subscale   [ Time Frame: 8 weeks ]

3.  Secondary:   West Haven-Yale Multidimensional Pain Inventory - Activity Subscales   [ Time Frame: 8 weeks ]

4.  Secondary:   SF-12 MCS   [ Time Frame: 8 weeks ]

5.  Secondary:   SF-12 PCS   [ Time Frame: 8 weeks ]

6.  Secondary:   Patient Health Questionnaire-9   [ Time Frame: 8 weeks ]

7.  Secondary:   Pain Anxiety Symptom Scale - 20   [ Time Frame: 8 weeks ]

8.  Secondary:   PTSD Checklist   [ Time Frame: 8 weeks ]

9.  Secondary:   Pittsburgh Sleep Quality Index   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Julie Wetherell
Organization: VA San Diego Healthcare System
phone: 858-552-8585 ext 2752
e-mail: jwetherell@ucsd.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01055639     History of Changes
Other Study ID Numbers: F6891-R
091019 ( Other Grant/Funding Number: GRANT00557035 )
Study First Received: January 21, 2010
Results First Received: June 19, 2015
Last Updated: June 30, 2016