NCT03344926

Brief Summary

The aims are to test feasibility and preliminary effects of a smart phone delivered ACT treatment for adults with longstanding pain. The hypotheses are that

  1. 1.ACTsmart will be a feasible and accessable treatment delivery form
  2. 2.ACTsmart will improve function and quality of life

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

November 14, 2017

Last Update Submit

January 20, 2020

Conditions

Chronic Pain

Keywords

Acceptance and Commitment therapyACTCBTSmart phoneInternetIntervention

Outcome Measures

Primary Outcomes (1)

  • Pain Interference Index (changes between assessments)

    Self rated measure of daily functioning related to pain

    Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment

Secondary Outcomes (9)

  • Psychological Inflexibility in Pain Scale (changes)

    Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment

  • Valuing Questionnaire (changes)

    Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment

  • Patient Health Questionnaire 9 (changes)

    Baseline, post (8 weeks), follow ups three, six and twelve months post treatment

  • European Quality of Life Five Dimensions Questionnaire (changes)

    Baseline, post (8 weeks), follow ups three, six and twelve months post treatment

  • Insomnia Severity Index (changes)

    Baseline, post (8 weeks), follow ups three, six and twelve months post treatment

  • +4 more secondary outcomes

Study Arms (1)

ACTsmart

EXPERIMENTAL

ACT treatment via a smart phone application

Behavioral: ACTsmart

Interventions

ACTsmartBEHAVIORAL

Participant receive ACT treatment via a smart phone application, including psychologist support via a message function within the application. Treatment content is divided into four modules: 1. education about pain behaviors, exposure and acceptance and commitment therapy 2. education about pain physiology 3. exercises on changing behaviors, acceptance, mindfulness, defusion and exposure 4. value based exposure in the participant's daily life

ACTsmart

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a pain duration of ≥ 6 months;
  • able to read and write in Swedish
  • have access to a smart phone with internet access
  • no planned changes in medication use, or any other changes in interventions for their pain planned

You may not qualify if:

  • injury or illness that require immediate assessment or different treatment, or that is expected to progress significantly during the next 6 months
  • unstable medication (planned changes in medication during next 4 months)
  • ACT or CBT treatment during the past 3 months
  • severe psychiatric co-morbidity (e.g. high risk of suicide) as assessed by the psychologist in a semi-structured interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institutet

Stockholm, Stockholm County, 171 77, Sweden

Location

Related Publications (1)

  • Gentili C, Zetterqvist V, Rickardsson J, Holmstrom L, Ljotsson B, Wicksell R. Examining predictors of treatment effect in digital Acceptance and Commitment Therapy for chronic pain. Cogn Behav Ther. 2023 Jul;52(4):380-396. doi: 10.1080/16506073.2023.2191826. Epub 2023 Mar 27.

    PMID: 36971108DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rikard Wicksell

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot study of treatment delivery in a new format.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

October 23, 2017

Primary Completion

December 23, 2019

Study Completion

December 23, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)