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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 19, 2012

Last Updated Date

October 2, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01603797 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Guided Internet-delivered Acceptance and Commitment Therapy for Chronic Pain Patients: a Randomized Controlled Trial

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Pain

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: Internet delivered ACT
Internet delivered acceptance and commitment therapy (ACT), 7 weeks treatment

Intervention: Behavioral: Guided internet-delivered acceptance and commitment therapy
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.

Intervention: Behavioral: Guided internet-delivered acceptance and commitment therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01603797

Other Study ID Numbers ^ICMJE

smartaSIAMB_GA

Has Data Monitoring Committee

Responsible Party

Gerhard Andersson, Linkoeping University

Study Sponsor ^ICMJE

Gerhard Andersson

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Linkoeping University

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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