Clinical trial NCT03504904: Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients
Official title: Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients: a Randomized Controlled, Internet Delivered, Treatment Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Self-Criticism
Keywords: Chronic pain
Self-criticism
Internet-based treatment
ACT
CFT
Guided self-help
Acceptance
Compassion
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: Örebro University, Sweden
name: Karlstad University
First posted: 2018-04-20
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: At 3, 8 weeks (post-treatment) and 6 months follow-up
measure: Self-Compassion Scale (SCS)
timeFrame: At 3, 8 weeks (post-treatment) and 6 months follow-up
measure: Pain Disability index (PDI)
timeFrame: At 8 weeks (post-treatment) and 6 months follow-up
Secondary outcomes:
measure: Montgomery Åsberg Depression Rating Scale (MADRS-S)
timeFrame: At 8 weeks (post-treatment) and 6 months follow-up
measure: Anxiety sensitivity index (ASI)
timeFrame: At 8 weeks (post-treatment) and 6 months follow-up
measure: Quality of Life Inventory (QOLI)
timeFrame: At 8 weeks (post-treatment) and 6 months follow-up
measure: Multidimensional Pain Inventory (MPI)
timeFrame: At 8 weeks (post-treatment) and 6 months follow-up
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: At 3, 8 weeks (post-treatment) and 6 months follow-up
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Psychology, Uppsala University
state: Uppland
Study officials:
affiliation: Uppsala University
name: Monica Buhrman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Örebro University, Sweden
name: Katja Boersma, PhD
role: STUDY_CHAIR
affiliation: Karlstad University
name: Maria Tillfors, PhD
role: STUDY_CHAIR
affiliation: Örebro University, Sweden
name: Fredrik Holländare, PhD
role: STUDY_CHAIR
References: