Internet-based Acceptance and Commitment Therapy for Chronic Pain

NCT03409302 | Unknown

• 1 other identifier: K3_K1_0c
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acceptance and Commitment Therapy (ACT) delivered face-to-face is an empirically supported intervention for the management of chronic pain (CP). However, increasing demands for cost reduction in healthcare services in addition to obstacles regarding physical access to treatment, highlight the need for innovative, cost-reducing, digital self-management interventions. Poor user engagement nonetheless, is a significant challenge often faced in digital interventions, which often results in poor adherence or even non-completion in treatment. In addition, very few digital trials appear to plan for adherence a-priori, when designing an intervention. To date there are only two ACT-based digital interventions for CP demonstrating significant improvements in pain-related disability and increased functioning, yet with small to medium effect sizes and poor adherence rates. However, several limitations of the studies such as the absence of a-priori adherence planning and lack of investigation of underlying mechanisms, makes it difficult to draw clear conclusions on the effectiveness of this new treatment modality for chronic pain and warrants further research. This study seeks to: a) explore how a brief adherence-planned digital ACT-based intervention for CP management, compared to an active control group and a wait-list control group improves targeted study outcomes such as functioning and quality of life, and b) investigate which processes of change mediate the targeted study outcomes. It is hypothesized that the brief ACT-based digital intervention in comparison to the active control group and wait-list will result in increased functioning, improved quality of life and reduced pain intensity. The results of the study are expected to shed more light on the utility of planning for adherence in digital interventions and effectiveness of ACT-based digital interventions and their underlying mechanisms in the management of CP.

Conditions

Chronic Pain

Keywords

ACT; digital intervention; web-based; adherence

Outcome Measures

Primary Outcomes (1)

• Changes in daily functioning assessed with the Greek Brief Pain Inventory: Interference sub-scale (G-BPI; Mystakidou, Mendoza, Tsilika, Befon, Parpa et al., 2001; Original: Cleeland & Ryan; 1994)

  This is a subscale of the Greek-Brief Pain Inventory which is a pain assessment tool developed to assess pain severity and interference which has been previously translated and validated in a Greek chronic pain sample. Pain severity is of secondary focus within the study and will be assessed by a numerical rating scale as described later. The interference subscale will only be used to assess how pain interferes in several areas of daily functioning of chronic pain sufferers. It contains 7-items rated on a Likert-type scale from 0="does not interfere" to 10="completely interferes". The G-BPI presents with good internal consistency (α=.85 for interference) and sufficient validity with theoretically-consistent instruments.

  Change in levels of daily functioning from baseline through study completion (approximately 2 months) and at 6 and 12 months post completion. Data will be reported for study completion (approximately 2 months), 6 months and 12 months

Secondary Outcomes (2)

• Changes in the quality of life assessed by the World Health Organisation Quality of Life-BREF Questionnaire (WHOQOL-BREF; The WHOQOL Group, 1998)

  Change in levels of quality of life from baseline through study completion (approximately 2 months) and at 6 and 12 months post completion. Data will be reported for study completion (approximately 2 months), 6 months and 12 months

• Changes in the levels of psychological distress assessed by the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)

  Change in levels of depression and anxiety symptoms from baseline through study completion (approximately 2 months) and at 6 and 12 months post completion. Data will be reported for study completion (approximately 2 months), 6 months and 12 months

Other Outcomes (6)

• Changes in avoidance of pain levels as assessed by the Greek Psychological Inflexibility in Pain Scale (G-PIPS-II; Vasiliou et al., under submission; Original: Wicksell et al., 2010)

  Change in levels of psychological flexibility from baseline through study completion (approximately 2 months) and at 6 and 12 months post completion. Data will be reported for study completion (approximately 2 months), 6 months and 12 months

• Changes in the levels of pain acceptance as assessed via the Greek Chronic Pain Acceptance Questionnaire (G-CPAQ; Vasiliou et al., under review; Original: McCracken et al., 2004)

  Change in levels of pain acceptance from baseline through study completion (approximately 2 months) and at 6 and 12 months post completion. Data will be reported for study completion (approximately 2 months), 6 months and 12 months

• Changes in the levels of defusion with pain-related thoughts as assessed via Cognitive Defusion Stamp (Karekla & Nicolaou, 2011)

  Change in levels of defusion at 4 points from baseline through completion (approximately once every week, prior to each session). Data will be reported once when study is completed (approximately 2 months after baseline)

Study Arms (2)

The ALGEapp (Brief i-ACT intervention)

EXPERIMENTAL

The intervention builds on a previously unpublished face-to-face protocol for greek-speaking chronic pain sufferers (developed by Karekla \& Vasiliou, 2013) and has been simplified and modified to produce a self-help digital internet-based modality, namely the ALGEApp. ALGEApp consists of a total of 4 approximately one-hour sessions, which are structured to be completed by the users in sequence within a time frame of 2-8 weeks (depending on the rate of completion by each user). The intervention is guided, which implies that an animated character (an Avatar) guides the user throughout the whole duration of the intervention. ALGEApp contains experiential and audiovisual psycho-educational material based on ACT, adopted for the Greek-Cypriot culture.

Behavioral: ALGEApp (Brief iACT intervention)

Active Control group

ACTIVE COMPARATOR

The Active control group will have access only to limited component of the ALGEApp intervention, namely the Bonus section, which contains limited psycho-educational information regarding pain management.

Behavioral: Active control group

Interventions

ALGEApp (Brief iACT intervention) BEHAVIORAL

Participants will be randomly assigned to one of the two groups: brief i-ACT intervention or active control group. The i-ACT intervention participants will be encouraged to login the website platform with their credentials and to complete 4 weekly sessions (1 session per week) which lasts about 1 hour each. Participants will be guided by a 3D- animated Avatar who adopts the role of a facilitator.

Also known as: ALGEApp

The ALGEapp (Brief i-ACT intervention)

Active control group BEHAVIORAL

Participants will be randomly assigned to one of the two groups: brief i-ACT intervention or active control group. The active control group will have access, through the same platform. only to limited online psycho-educational information regarding pain. Active control group will complete pre-treatment and post-treatment questionnaires in parallel with the intervention group.

Active Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• At least 3 months chronic pain duration,
• At least a pain intensity score of ≥ 4 prior to the intervention (assessed by an 11 point numeric rating scale (NRS; Dworkin et al., 2005) ranging from (0) 'no pain' to (10) 'pain as bad as the participant can imagine'.
• Users to have undergone medical assessment within one year,
• Official medical diagnosis on the type of chronic pain that users suffer from,
• Regular access to a computer/tablet and internet
• Sufficient knowledge of the Greek language.

You may not qualify if:

• Comorbidity with a serious medical condition other than chronic non-malignant pain (e.g., complete paraplegia or tetraplegia, heart or vascular diseases, malignant pain such as cancer etc.), which may interfere with participation. A neurologist will be consulted and candidates will be excluded if their medical condition is regarded as significantly interfering with their participation.
• Recent episodes of active psychosis, manic episodes, substance use disorder and suicidal ideation. Assessment will take place using selected single items from mini-SCID (mini - Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Karekla \& Panayiotou 2010). Candidates who respond positively to one or more of the assessed mini-SCID items will be excluded from further participation and will receive information over the phone with advice to seek help, along with relevant information on available services from their local community mental health services or their general practitioner.

Sponsors & Collaborators

• University of Cyprus: lead

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Karekla, Ph.D

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Karekla, Ph.D

CONTACT

0035722892100; mkarekla@ucy.ac.cy

Orestis Kasinopoulos, M.Sc

CONTACT

0035799454398; okasin01@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind (subject, outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed Clinical Psychologist, Assistant Professor, Peer reviewed ACT trainer

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: January 24, 2018
• Study Start: January 1, 2018
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 24, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share