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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Guided internet-delivered acceptance and commitment therapy

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring internetdelivered CBT, chronic pain, acceptance and commitment therapy, mindfulness, guided self help

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internet delivered ACT

Online discussion forum

Arm Description

Internet delivered acceptance and commitment therapy (ACT), 7 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

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 (α =.72-.92).

Secondary Outcome Measures

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.

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

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.

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.

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.

Full Information

NCT ID

NCT01603797

First Posted

May 19, 2012

Last Updated

October 2, 2012

Sponsor

Gerhard Andersson

1. Study Identification

Unique Protocol Identification Number

NCT01603797

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

December 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 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.

6. Conditions and Keywords

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

Chronic Pain

Keywords

internetdelivered CBT, chronic pain, acceptance and commitment therapy, mindfulness, 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

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet delivered ACT

Arm Type

Experimental

Arm Description

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

Arm Title

Online discussion forum

Arm Type

Active Comparator

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-delivered acceptance and commitment therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Chronic Pain Acceptance Questionnaire (CPAQ)

Description

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).

Time Frame

One week pre- and post-treatment

Secondary Outcome Measure Information:

Title

Hospital and Anxiety Depression Scale (HADS)

Description

HADS contains 14 items and evaluates severity of symptoms of depression and anxiety without contamination of scores of physical symptomatology.

Time Frame

One week pre- and post- treatment

Title

The Coping Strategies Questionnaire (CSQ)

Description

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

Time Frame

One week pre- and post- treatment

Title

Multidimensional Pain Inventory (MPI-S)

Description

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.

Time Frame

One week pre- and post- treatment

Title

The Pain and Impairment Relationship Scale (PAIRS)

Description

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.

Time Frame

One week pre- and post- treatment

Title

Quality of Life Inventory (QOLI)

Description

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.

Time Frame

One week pre- and post- treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials: