Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients

NCT ID: NCT03504904

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-13
• Study Completion Date: 2016-01-23

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.

Detailed Description

The purpose of this study was to explore if a psychological treatment fusing ACT and CFT principles and therapeutic techniques could improve outcome in chronic pain patients with high levels of self-criticism in comparison to a wait-list control group. The treatment was delivered via the internet, guided by trained professional. Internet delivered cognitive behavior therapy (CBT) and ACT treatments have shown similar efficacy as compared to face-to-face treatments in a variety of problem areas and across a large range of outcomes. Participants were recruited from a clinical setting. The treatment program consisted of eight sections and was based on a manual based on ACT developed for chronic pain (Buhrman et al., 2013) and a CFT-manual for chronic pain.

Following a screening interview participants deemed eligible were asked to complete an assessment battery online. All correspondence concerning treatment was held through a web portal including the online questionnaires and a secure e-mail service. The system handled security issues with two factor authentication. The participants logged in with electronic identification which is a secure service used by banks and in clinical settings.

Measures were obtained pre- and post- intervention and administered via the internet. A sixth month follow-up of the treatment group was administered. Mediation measures were also obtained.

Conditions

Chronic Pain; Self-Criticism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-delivered ACT and CFT

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

Group Type: EXPERIMENTAL

Internet-Delivered ACT and CFT

Intervention Type: BEHAVIORAL

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

Wait list control group

Wait list control group, received treatment at later point.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-Delivered ACT and CFT

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: collaborator

Karlstad University

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Buhrman, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Katja Boersma, PhD

Role: STUDY_CHAIR

Örebro University, Sweden

Maria Tillfors, PhD

Role: STUDY_CHAIR

Karlstad University

Fredrik Holländare, PhD

Role: STUDY_CHAIR

Örebro University, Sweden

Locations

Department of Psychology, Uppsala University

Uppsala, Uppland, Sweden

Countries

Sweden

Other Identifiers

214/248

Identifier Type: -

Identifier Source: org_study_id