Guided Internet-delivered Acceptance and Commitment Therapy for Chronic Pain Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Andersson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01603797
First received: May 19, 2012
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

The aim of this study was to investigate if guided internet-delivered acceptance and commitment therapy (ACT)would help chronic pain patients.


Condition Intervention
Chronic Pain
Behavioral: Guided internet-delivered acceptance and commitment therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guided Internet-delivered Acceptance and Commitment Therapy for Chronic Pain Patients: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Chronic Pain Acceptance Questionnaire (CPAQ) [ Time Frame: One week pre- and post-treatment ] [ Designated as safety issue: No ]
    CPAQ consists of 20 items divided into two subscales: activity engagement and pain willingness. Items are rated on a scale from 0 (never true) to 6 (always true). Higher scores denote greater activity engagement and pain willingness. Studies show acceptable reliability (α =.72-.92).


Secondary Outcome Measures:
  • Hospital and Anxiety Depression Scale (HADS) [ Time Frame: One week pre- and post- treatment ] [ Designated as safety issue: No ]
    HADS contains 14 items and evaluates severity of symptoms of depression and anxiety without contamination of scores of physical symptomatology.

  • The Coping Strategies Questionnaire (CSQ) [ Time Frame: One week pre- and post- treatment ] [ Designated as safety issue: No ]
    The CSQ contains 50 items divided into eight scales measuring different cognitive and behavioural coping strategies and has been widely used by chronic pain patients. The coping strategies scales are: diverting attention, re-interpreting pain sensations, coping self-statements, ignoring sensations, praying and hoping, catastrophizing and increased behavioral activities

  • Multidimensional Pain Inventory (MPI-S) [ Time Frame: One week pre- and post- treatment ] [ Designated as safety issue: No ]
    The Swedish version of MPI (MPI-S) consists of 34 items divided into 8 scales. The first section addresses: Pain Severity, Interference, Life Control, Affective Distress and Support. The second section addresses the patient's perception of how significant others respond to their displays of pain: Punishing Responses, Solicitous Responses and Distracting Responses.

  • The Pain and Impairment Relationship Scale (PAIRS) [ Time Frame: One week pre- and post- treatment ] [ Designated as safety issue: No ]
    PAIRS assess beliefs and attitudes associated with the experience of chronic pain and one's ability to function despite pain. It consists of 15 personal statements that reflect thoughts, attitudes and opinions about pain.

  • Quality of Life Inventory (QOLI) [ Time Frame: One week pre- and post- treatment ] [ Designated as safety issue: No ]
    QOLI consists of 32 items for assessing life satisfaction. The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighborhood, and community.


Enrollment: 76
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet delivered ACT
Internet delivered acceptance and commitment therapy (ACT), 7 weeks treatment
Behavioral: Guided internet-delivered acceptance and commitment therapy
The treatment program consisted of seven sections and was based on ACT.The first part was about creative hopelessness and was followed in the next section by an introduction to willingness and to the process of acceptance of pain. Information and assignments about committed action and values were also part of the treatment program. Mindfulness exercises were a regular feature in the program. The last part was about how to maintain learned strategies but also an evaluation of the program.
Active Comparator: Online discussion forum
Active wait-list condition. Were offered to participate in a moderated online discussion forum. After post-treatment assessment the control group were offered treatment.
Behavioral: Guided internet-delivered acceptance and commitment therapy
The treatment program consisted of seven sections and was based on ACT.The first part was about creative hopelessness and was followed in the next section by an introduction to willingness and to the process of acceptance of pain. Information and assignments about committed action and values were also part of the treatment program. Mindfulness exercises were a regular feature in the program. The last part was about how to maintain learned strategies but also an evaluation of the program.

Detailed Description:

The present study investigates internet-delivered ACT for persons with chronic pain. The use of internet as a delivery format for interventions could be a way of overcome many barriers (financial obstacles, reluctance to seek treatment and paucity of clinicians trained in ACT) that hinder persons with chronic pain to seek or receive adequate help. Persons were randomized to either treatment for 7 weeks or to a control group who were invited to participate in a moderated online discussion forum. Follow up data was collected six months after the treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • that participants had undergone medical investigation (within one year)
  • had regular access to the internet
  • had functional impairment caused by chronic pain
  • had internet access

Exclusion Criteria:

  • ongoing medical investigations or treatment that could interfere with participation in the study, such as planned surgery and suffering from acute physical or psychological conditions
  • not fluent in the Swedish language
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603797

Sponsors and Collaborators
Gerhard Andersson
Investigators
Study Director: Gerhard Andersson, Professor Linkoeping University
Principal Investigator: Monica Buhrman, MSc Uppsala University
Study Chair: Timo Hursti, PhD Uppsala University
Study Chair: Torsten Gordh, Professor Uppsala University
Study Chair: Tomas Furmark, Professor Uppsala University
Study Chair: Astrid Skoglund, MSc Uppsala University
Study Chair: Josefin Husell, MSc Uppsala University
Study Chair: Kristina Bergström, MSc Uppsala University
Study Chair: Nina Bendelin, MSc Linkoeping University
  More Information

No publications provided

Responsible Party: Gerhard Andersson, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT01603797     History of Changes
Other Study ID Numbers: smartaSIAMB_GA
Study First Received: May 19, 2012
Last Updated: October 2, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
internetdelivered CBT
chronic pain
acceptance and commitment therapy
mindfulness
guided self help

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014