Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients

NCT03504904 | Completed

• 1 other identifier: 214/248
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a randomized controlled study aiming to investigate the effect of an 8-week internet-based intervention focused on acceptance and compassion or a wait-list control group. Primary treatments outcomes are Chronic Pain Acceptance Questionnaire (CPAQ), Self-Compassion Scale (SCS) and Pain Disability index (PDI). Secondary outcomes were Montgomery Åsberg Depression Rating Scale (MADRS-S), Anxiety sensitivity index (ASI), Quality of Life Inventory (QOLI), Multidimensional Pain Inventory (MPI) and Perseverative Thinking Questionnaire (PTQ). A six month follow-up was conducted. Findings showed significantly greater levels of acceptance (CPAQ), self-compassion (SCS) and reduction in activity limitation (PDI) measured with the primary outcomes for the treatment group after the intervention with effect sizes raging from small to moderate and these results were maintained at six-month follow-up.

Conditions

Chronic Pain; Self-Criticism

Keywords

Chronic pain; Self-criticism; Internet-based treatment; ACT; CFT; Guided self-help; Acceptance; Compassion

Outcome Measures

Primary Outcomes (3)

• Chronic Pain Acceptance Questionnaire (CPAQ)

  Chronic pain acceptance questionnaire (CPAQ) measures acceptance. The measure consists of two scales; willingness and activity engagement. Items are rated on a scale from 0 (never true) to 6 (always true).Higher scores denote greater activity engagement and pain willingness.The total score is also reported

  At 3, 8 weeks (post-treatment) and 6 months follow-up

• Self-Compassion Scale (SCS)

  Change from baseline in compassion. The items in Self-Compassion Scale (SCS) are rated on a likert scale from 1(almost never) to 5 (almost always). The scale is divided into six subscales: self-kindness (higher values are considered better), self-judgement (lower values are considered better), common humanity (higher values are considered better), isolation(lower values are considered better), mindfulness (highervalues are considered better) and over-identified (lower values are considered better).Higher scores in the total scale indicate higher levels of compassion. l scale.Results can be presented for the different subclass or a total score. To compute a total self-compassion score, you reverse the negative scales items (self-judgment, isolation, and over-identification ) before computing the grand mean. Subscale scores are computed by calculating the mean of subscale item responses. Higher scores indicate higher levels of self-compassion. A total score can also be reported.

  At 3, 8 weeks (post-treatment) and 6 months follow-up

• Pain Disability index (PDI)

  Change from baseline in disability. It measures the degree to which pain. Every item score can range from 0 (no interference) to 10 (total interference). The total PDI score can range from 0 to 70, a higher score indicating more interference interferes with functioning across a range of activities.

  At 8 weeks (post-treatment) and 6 months follow-up

Secondary Outcomes (5)

• Montgomery Åsberg Depression Rating Scale (MADRS-S)

  At 8 weeks (post-treatment) and 6 months follow-up

• Anxiety sensitivity index (ASI)

  At 8 weeks (post-treatment) and 6 months follow-up

• Quality of Life Inventory (QOLI)

  At 8 weeks (post-treatment) and 6 months follow-up

• Multidimensional Pain Inventory (MPI)

  At 8 weeks (post-treatment) and 6 months follow-up

• Perseverative Thinking Questionnaire (PTQ)

  At 3, 8 weeks (post-treatment) and 6 months follow-up

Study Arms (2)

Internet-delivered ACT and CFT

EXPERIMENTAL

8 week, guided internet- delivered acceptance and commitment therapy (ACT) and compassion focused therapy (CFT)

Behavioral: Internet-Delivered ACT and CFT

Wait list control group

NO INTERVENTION

Wait list control group, received treatment at later point.

Interventions

Internet-Delivered ACT and CFT BEHAVIORAL

An 8-week internet-based intervention focused on acceptance and compassion. Psychological intervention based on Acceptance and commitment therapy and compassion focused therapy

Internet-delivered ACT and CFT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have experienced pain for more than three months,
• have been medically investigated (within the past year)
• be at least 18 years of age
• have regular access to a computer and the internet
• reported self-criticism measured with the Self-Compassion Scale.

You may not qualify if:

• planned surgery
• ongoing medical investigation that could impede participation in the study,
• suffering from acute physical or psychological conditions,
• very severe symptoms of depression (i.e., defined as a score of \>2 on item 9 on MADRS-S and information from telephone screening)
• ongoing psychological treatment,
• not being fluent with the Swedish language since all the material would be in Swedish.

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator
• Örebro University, Sweden: collaborator
• Karlstad University: collaborator

Study Sites (1)

Department of Psychology, Uppsala University

Uppsala, Uppland, 75236, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Monica Buhrman, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Katja Boersma, PhD

  Örebro University, Sweden

  STUDY CHAIR

• Maria Tillfors, PhD

  Karlstad University

  STUDY CHAIR

• Fredrik Holländare, PhD

  Örebro University, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: November 13, 2014
• Primary Completion: January 23, 2016
• Study Completion: January 23, 2016
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)