Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gerhard Andersson, Linkoeping University

ClinicalTrials.gov Identifier:

NCT01491269

First received: December 7, 2011

Last updated: December 11, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2011

Last Updated Date

December 11, 2011

Start Date ^ICMJE

August 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The Coping Strategies Questionnaire (CSQ) [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]

The CSQ contains 50 items divided in eight scales that measures different cognitive and behavioral coping strategies. The different coping strategies are: diverting attention, re-interpreting pain sensations, coping self-statements, ignoring sensations, praying and hoping, catastrophizing, increased behavioral activities and pain behavior (Rosenthiel & Keefe, 1983). Change from baseline in the different subscales pre- and post treatment.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01491269 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hospital Anxiety and Depression Scale, HADS [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
HADS is a 14-item questionnaire, and is designed to measure anxiety and depression in non-psychiatric patients.
Multidimensional Pain Inventory, MPI [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
MPI, assess psychosocial and behavioural consequences of pain. It´s divided into 2 sections and consisting of 8 scales. These are: Pain Severity, Interference, Life Control, Affective Distress, Support, Punishing Responses, Solicitous Responses and Distracting Responses.
Pain and Impairment Relationship Scale (PAIRS) [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
PAIRS consist of 15 personal statements that reflect thoughts, attitudes and opinions about pain. The questionnaire assesses beliefs and attitudes that patients have regarding pain and ability to function despite discomfort.
Quality of Life Inventory (QOLI) [ Time Frame: One week pre treatment, one week post after treatment ] [ Designated as safety issue: No ]
QOLI contains 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. Each item is rated in terms of importance and satisfaction.
Chronic Pain Acceptance Questionnaire (CPAQ) [ Time Frame: One week pre treatment, one week post treatment ] [ Designated as safety issue: No ]
CPAQ contains 20 items divided in two scales, engagement and willingness. CPAQ measures acceptance in relation to chronic pain.

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 Cognitive-behavioral Therapy for Former Chronic Pain Patients

Official Title ^ICMJE

Guided Internet-delivered Cognitive-behavioral Therapy for Former Chronic Pain Patients: Randomised Controlled Trial

Brief Summary

The aim of the present study was to investigate if guided Internet-delivered Cognitive-behavioral Therapy (CBT) would help chronic pain patients who had previously undergone a multidisciplinary treatment but still have residual problems.

Detailed Description

The present study investigates Internet-delivered CBT as a tertiary intervention. This is motivated by the fact that many pain patients relapse after rehabilitation and some may be in need of additional treatment. The persons who fulfills the inclusion criteria undergoes a structured telephone interview. The study is a experimental design with a treatment and an active control group measured before and after a treatment period. The control group 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-based cognitive behavioural treatment

Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.

Study Arm (s)

Experimental: Internet delivered CBT
Internet delivered cognitive behavioral intervention, 8 weeks treatment.

Intervention: Behavioral: Guided Internet-based cognitive behavioural treatment
No Intervention: Control condition
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-based cognitive behavioural treatment

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

June 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

to have been medically investigated (within one year)
completed the multidisciplinary rehabilitation program
have residual symptoms after the rehabilitation treatment (defined as functional impairment caused by their pain)
have Internet access

Exclusion Criteria:

planned surgery
ongoing medical investigation that could impede participation in the study
suffering from acute physical or psychological conditions
people confined to wheelchairs
people not fluent with the Swedish language

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01491269

Other Study ID Numbers ^ICMJE

smartaMB2011

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	Linköping University
Principal Investigator:	Monica Buhrman, MSc	Uppsala University
Study Chair:	Timo Hursti, PhD	Uppsala University
Study Chair:	Torsten Gordh, Professor	Uppsala University
Study Chair:	Anna Fredriksson, MSc	Uppsala University
Study Chair:	Gunnel Edström, MSc	Uppsala University
Study Chair:	Dorna Shaffi, MSc	Uppsala University
Study Chair:	Carolina Törnqvist, MSc	Uppsala University
Study Chair:	Brjann Ljotsson, PhD	Karolinska Institutet, Stockholm

Information Provided By

Linkoeping University

Verification Date

December 2011

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

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