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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Guided Internet-based cognitive behavioural treatment

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, internet delivered CBT, tertiary intervention, mindfulness, applied relaxation, guided self help

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet delivered CBT

Control condition

Arm Description

Internet delivered cognitive behavioral intervention, 8 weeks treatment.

Active wait-list condition. Were offered to participate in a moderated online discussion forum. After post-treatment assessment the control group were offered treatment.

Outcomes

Primary Outcome Measures

The Coping Strategies Questionnaire (CSQ)

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.

Secondary Outcome Measures

Hospital Anxiety and Depression Scale, HADS

HADS is a 14-item questionnaire, and is designed to measure anxiety and depression in non-psychiatric patients.

Multidimensional Pain Inventory, MPI

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)

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)

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)

CPAQ contains 20 items divided in two scales, engagement and willingness. CPAQ measures acceptance in relation to chronic pain.

Full Information

NCT ID

NCT01491269

First Posted

December 7, 2011

Last Updated

December 11, 2011

Sponsor

Gerhard Andersson

1. Study Identification

Unique Protocol Identification Number

NCT01491269

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gerhard Andersson

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

chronic pain, internet delivered CBT, tertiary intervention, mindfulness, applied relaxation, guided self help

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet delivered CBT

Arm Type

Experimental

Arm Description

Internet delivered cognitive behavioral intervention, 8 weeks treatment.

Arm Title

Control condition

Arm Type

No Intervention

Arm Description

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 Type

Behavioral

Intervention Name(s)

Guided Internet-based cognitive behavioural treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

The Coping Strategies Questionnaire (CSQ)

Description

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.

Time Frame

One week pre treatment, one week post treatment

Secondary Outcome Measure Information:

Title

Hospital Anxiety and Depression Scale, HADS

Description

HADS is a 14-item questionnaire, and is designed to measure anxiety and depression in non-psychiatric patients.

Time Frame

One week pre treatment, one week post treatment

Title

Multidimensional Pain Inventory, MPI

Description

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.

Time Frame

One week pre treatment, one week post treatment

Title

Pain and Impairment Relationship Scale (PAIRS)

Description

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.

Time Frame

One week pre treatment, one week post treatment

Title

Quality of Life Inventory (QOLI)

Description

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.

Time Frame

One week pre treatment, one week post after treatment

Title

Chronic Pain Acceptance Questionnaire (CPAQ)

Description

CPAQ contains 20 items divided in two scales, engagement and willingness. CPAQ measures acceptance in relation to chronic pain.

Time Frame

One week pre treatment, one week post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: