Internet-based Acceptance and Commitment Therapy for Chronic Pain (ALGEApp)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03409302|
Recruitment Status : Not yet recruiting
First Posted : January 24, 2018
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: ALGEApp (Brief iACT intervention) Behavioral: Active control group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blind (subject, outcome assessor)|
|Official Title:||The Effectiveness of a Brief Digital ACT Intervention for Chronic Pain|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: The ALGEapp (Brief i-ACT intervention)
The intervention builds on a previously unpublished face-to-face protocol for greek-speaking chronic pain sufferers (developed by Karekla & Vasiliou, 2013) and has been simplified and modified to produce a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)
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.
Other Name: ALGEApp
Active Comparator: Active Control group
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
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.
- 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) [ Time Frame: 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 ]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.
- Changes in the quality of life assessed by the World Health Organisation Quality of Life-BREF Questionnaire (WHOQOL-BREF; The WHOQOL Group, 1998) [ Time Frame: 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 ]The WHOQOL assesses an individual's quality of life (QoL). The instrument is a self-report 26-item inventory of generic QoL and is divided into four subscales: physical health, mental health, social relationships, and social environment. Higher scores indicate better QoL. WHOQOL-BREF has been previously translated and validated in Greek (Ginieri-Coccossis, Triantafillou, Tomaras, Soldatos, Mavreas, & Christodoulou, 2012) with satisfactory internal consistency between the domains ranging from (Cronbach's α=.66 - .80) and overall QoL (α= .87) and seems to function well for assessing QoL in clinical and general populations.
- Changes in the levels of psychological distress assessed by the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) [ Time Frame: 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 ]HADS is a 14-item questionnaire assessing levels of depression and anxiety symptomatology, considered unbiased by coexisting medical conditions (Snaith, 1987). Each subscale consists of 7 items rated on a 4-point scale (0-3). Higher scores indicate greater anxiety and depression. The Greek version presents with high internal consistency (α=.88) and validity (Michopoulos, et al., 2008).
- 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) [ Time Frame: 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 ]G-PIPS-II contains 12 items assessing psychological inflexibility and is comprised of two subscales: a) avoidance of pain (8 items), examines behaviors that lead to avoidance of pain and related distress; and b) cognitive fusion (4 items), assesses how CP sufferers' thoughts about an event can lead to avoidance of pain or distress. Items are rated on a 7-point Likert-type scale, with 1="never true" and 7="always true". The scale demonstrates good psychometric properties (Wicksell et al., 2010) and high internal consistency (α = .88) and validity with associated constructs in its Greek version.
- 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) [ Time Frame: 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 ]assesses pain acceptance in two sub-factors: activity engagement (4 items) and pain willingness (4 items). Activity engagement, examines the degree to which participants engage in meaningful activity even in the presence of pain. Pain willingness, assesses the degree to which individuals allow pain to occur without trying to change, control, or struggle with it. The G-CPAQ is rated on a 7-point Likert scale (0=never true to 6=always true) and yields a total sum with a range of 0-48. Higher total score suggests greater pain acceptance, whereas higher subscale scores denote greater activity engagement and pain willingness (McCracken et al., 2014). The G-CPAQ presents with high reliability (Cronbach's a=.80) and sufficient construct validity with theoretically-related constructs.
- Changes in the levels of defusion with pain-related thoughts as assessed via Cognitive Defusion Stamp (Karekla & Nicolaou, 2011) [ Time Frame: 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) ]): This is a figurative measure developed and used previously in several studies (e.g., Savvide & Karekla, 2015) to assess weekly changes in participants' cognitive defusion related to sabotaging thoughts. It was found to be sensitive to session-to-session changes and correlated significantly with other cognitive defusion measures. In this study the Cognitive Defusion Stamp will be used to assess how fused participants are with thoughts related to pain. CP sufferers will use a circular electronic stamp to show where they consider themselves to be in relation to an existing stamp, which represents pain related thoughts (i.e. "How fused is the participant today with their pain related thoughts?"). The mean distance in mm between the centers of the 2 circles are measured. The longer the distance between the two centers the more defusion from thoughts.
- Changes in the levels of satisfaction with treatment as assessed by the Greek Client Satisfaction Questionnaire (CSQ-8; Flora & Stalikas; 2012; Larsen, Attkinson, Hargreaves & Nguyen, 1979) [ Time Frame: Change in levels of satisfaction from baseline through study completion (approximately 2 months). Data will be reported once when study is completed (approximately 2 months after baseline) ]G-CSQ-8 will be used to assess participants' evaluation of the intervention and satisfaction. The scale demonstrated high internal consistency (α= .83). Items are rated on a 4-point Likert-type scale, where higher scores indicate greater satisfaction with services received.
- Perceived general improvement by the intervention as assessed by the Patient Global Impression of Change scale (PGIC; Guy, 1976) [ Time Frame: This single item is only delivered through study completion (approximately 2 months after baseline). Data will be reported once when study is completed (approximately 2 months after baseline) ]Following the IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) recommendations, the PGIC will be used to assess the participants' global perceived improvement following treatment. This is a one-item 7-point scale ranging from "very much improved" to "very much worse", with "no change" as the mid-point.
- Within-treatment diary [ Time Frame: Change in levels of processes at 4 points from baseline through study completion (approximately once every week, prior to each session). Data will be reported once when study is completed (approximately 2 months after baseline) ]At the beginning of each session participants will complete an 8-item diary: 1 item to assess each process of the psychological flexibility hexaflex (willingness, cognitive defusion, contact with present moment, values, committed action and self as context) including an item for pain struggle and pain intensity. Each item is rated on a numerical rating scale of a 1-5 with a specified time-frame (of previous week).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409302
|Contact: Maria Karekla, Ph.Demail@example.com|
|Contact: Orestis Kasinopoulos, M.Scfirstname.lastname@example.org|
|Principal Investigator:||Maria Karekla, Ph.D||University of Cyprus|