NCT02658474

Brief Summary

The purpose of this study is to determine whether group based Acceptance and Commitment Therapy (ACT) at a university hospital clinic is superior to treatment in a primary care setting among patients with chronic pain. Hypothesis: i) A group based ACT treatment leads to less pain and greater Health Related Quality of Life (HRQOL) in patients with chronic pain than treatment in a primary care setting. ii) The improvement in pain and HRQOL is mediated through an increased degree of pain willingness and involvement in activities. iii) Improvement of pain and HRQOL after the two treatments is associated with demographic, psychosocial and somatic characteristics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2021

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

5.2 years

First QC Date

January 14, 2016

Last Update Submit

May 7, 2025

Conditions

Chronic Pain

Keywords

Chronic painAcceptance and Commitment TherapyMultidisciplinary treatmentGroup treatment

Outcome Measures

Primary Outcomes (4)

  • Group difference in pain intensity

    Continuous variable (Numeric rating scale) analyzed by Mixed Model

    3 months after baseline

  • Group difference in pain intensity

    Continuous variable (Numeric rating scale) analyzed by Mixed Model

    6 months after baseline

  • Group difference in health related quality of life

    Health related quality of life is measured by Short Form-36 and analyzed by Mixed Model

    3 months after baseline

  • Group difference in health related quality of life

    Health related quality of life is measured by Short Form-36 and analyzed by Mixed Model

    6 months after baseline

Secondary Outcomes (11)

  • Change from baseline in pain intensity

    3 months after baseline

  • Change from baseline in pain intensity

    6 months after baseline

  • Change from baseline in pain intensity

    12 months after baseline

  • Change from baseline in health related quality of life

    3 months after baseline

  • Change from baseline in health related quality of life

    6 months after baseline

  • +6 more secondary outcomes

Study Arms (2)

ACT-group

EXPERIMENTAL

Group based Acceptance and Commitment Therapy. The patients will attend to three sessions which last for three days. Between the sessions the patients will train at home on ACT related topics. The whole intervention will last for three months.

Behavioral: Acceptance and Commitment Therapy

Primary care

NO INTERVENTION

Treatment in a primary care setting.

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

Group based Acceptance and Commitment Therapy

ACT-group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Long-term pain condition over 6 months.
  • Strongest pain ≥ 4 on a scale of 0 to 10.
  • Consent competent and over 18 years
  • Motivated for group-based psychological (ACT) treatment.

You may not qualify if:

  • Psychiatric illness and behavioral problems, including substance abuse that prevents good group interaction
  • Severe progressive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gunnvald Kvarstein, PhD

    UiT The Arctic University of Tromsø

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

August 1, 2016

Primary Completion

October 2, 2021

Study Completion

October 2, 2021

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)