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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01603797
Other study ID # smartaSIAMB_GA
Secondary ID
Status Completed
Phase N/A
First received May 19, 2012
Last updated October 2, 2012
Start date February 2010
Est. completion date December 2010

Study information

Verified date October 2012
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date December 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gerhard Andersson

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic Pain Acceptance Questionnaire (CPAQ) 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 (a =.72-.92). One week pre- and post-treatment No
Secondary Hospital and Anxiety Depression Scale (HADS) HADS contains 14 items and evaluates severity of symptoms of depression and anxiety without contamination of scores of physical symptomatology. One week pre- and post- treatment No
Secondary The Coping Strategies Questionnaire (CSQ) 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 One week pre- and post- treatment No
Secondary Multidimensional Pain Inventory (MPI-S) 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. One week pre- and post- treatment No
Secondary The Pain and Impairment Relationship Scale (PAIRS) 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. One week pre- and post- treatment No
Secondary Quality of Life Inventory (QOLI) 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. One week pre- and post- treatment No
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