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van CCT (UK)

van CCT (UK)

Effectiveness of an online self-help intervention for chronic pain based on Acceptance & Commitment Therapy (ACT) and mindfulness.

- candidate number13428
- NTR NumberNTR3659
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2012
- Secondary IDsNL38622.044.11 METC Twente
- Public TitleEffectiveness of an online self-help intervention for chronic pain based on Acceptance & Commitment Therapy (ACT) and mindfulness.
- Scientific TitleWeb-based intervention based on Acceptance & Commitment Therapy (ACT) and mindfulness for chronic pain: A randomized controlled trial.
- hypothesisThe primary objective of this study is to evaluate the web-based intervention 'Leven met Pijn' in comparison to a minimal intervention condition and a waiting list control condition in terms of a decrease in pain interference in daily life. The secondary objective of this study is to evaluate ¡®Leven met Pijn¡¯ in terms of a decrease in pain disability and pain intensity, and an increase in mental health, psychological flexibility, mindfulness and values-based living. Another objective of the study is to evaluate the mediating effects of psychological inflexibility and mindfulness in the effects described in the primary objective.
- Healt Condition(s) or Problem(s) studiedChronic pain
- Inclusion criteria1. Older than 18 years;
2. Chronic pain longer > 6 months (self-report);
3. Scores on pain intensity (NRS) above '4' (10-point scale);
4. Pain on 'daily' basis (4 - 7 days per week).
- Exclusion criteria1. Severe psychiatric problems (screening with HADS, WSQ and M.I.N.I.);
2. Extremely low scores on psychological inflexibility (PIPS; more than 2 SD below mean of population of chronic pain patients in a pain rehabilitation centre);
3. Having no access to the Internet at home and having no e-mail address;
4. Not enough time to follow the intervention;
5. Reading problems (due to insufficient Dutch language skills or illiteracy);
6. Enrollment in cognitive behavioural treatment at moment of entry study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-jun-2013
- Target number of participants160
- Interventions1. Experimental condition: Web-based intervention ‘Leven met Pijn’, based on Acceptance & Commitment Therapy (ACT) and mindfulness.The objective of ACT is enhancing psychological flexibility in favour of a meaningful life. Psychological flexibility is the ability to accept negative sensations, emotions and thoughts, to stay in contact with the present moment and to be able to act in line with one’s life values;
2. First control condition, minimal intervention group: Web-based intervention based on Expressive Writing (Pennebaker, 1997). The general assignment for all participants is to write on a daily or regular basis about negative emotions experienced during the day. Writing will take approximately 15-30 minutes;
3. Second control condition, waiting list group: Participants will be placed on a waiting list.

Time period of the intervention will be 12 weeks.
- Primary outcomeMultidimensional Pain Inventory – subscale pain interference (MPI – interference) (Kerns et al., 1985; Lousberg et al., 1999): The Multidimensional Pain Inventory was developed to assess various aspects of chronic pain and disability (Kerns et al, 1985). The subscale pain interference focuses on a psychosocial aspect of chronic pain: the interference in daily life due to pain. The scale consists of 11 items measuring pain interference in daily life with work, homework chores and social activities. All items can be answered on a 7-point Likert scale, higher scores indicating more interference. The MPI has been translated into Dutch and was validated thoroughly (Lousberg et al., 1999).
- Secondary outcome1. Hospital Anxiety Depression Scale (Zigmond & Snaith, 1983): The HADS measures presence and severity of anxiety and depressive symptoms. The scale consists of 14 items in total, 7 for each subscale. Answering categories range from 0 (‘not at all’) to 4 (‘very often’). A summed score can be achieved ranging from 0 – 21 for both subscales separately. Concurrent validity of the HADS-A is very good and the measure has good internal consistencies (Zigmond & Snaith, 1983; Spinhoven et al., 1997);
2. Mental health Continuum – Short Form (MHC-SF) (Keyes et al., 2005; Lamers Westerhof, ten Klooster & Keyes, 2010): The MHC-SF is a 14-item questionnaire that measures three dimension of positive mental health (Keyes, 2002): emotional well-being (3), defined in terms of positive feelings and satisfaction with life; psychological well-being (6), defined in terms of positive functioning in individual life (self-realization); social well-being (5), defined in terms of positive functioning in community life (being of social value). Participants are asked to rate the frequency of feelings they have experienced in the past month. Items are scored on a 6-point scale ranging from ‘never’ to ‘every day. Higher scores indicate better well-being. The Dutch version of the MHC-SF has shown good construct validity and test-retest reliability in the general adult population (Lamers et al., 2010);
3. Pain Disability Index (PDI) (Pollard, 1984): The PDI is an instrument developed to assess the degree to which chronic pain disables a person to perform daily activities (Tait, Chibnall & Krause, 1990). Seven items regarding various activities are rated by the participants on a 0-10 point scale ranging from ‘no disability’ to ‘total disability’. Several studies support the reliability and validity of the PDI (e.g. Tait et al., 1990);
4. Pain intensity – Numeric Rating Scale (NRS): Pain intensity is measured with a 11-point numeric rating scale, ranging from ‘no pain’ (0) to ‘pain as bad as you can imagine’ (10). The exact format of this rating will be as is recommended in the last IMMPACT recommendations on core outcome measures in chronic pain research (Dworkin et al., 2005);
5. Five Facet Mindfulness Questionnaire – Short Form (FFMQ-SF) (Baer, Smith, Hopkins, Krietemeyer & Toney, 2006; Bohlmeijer, ten Klooster, Fledderus, Veehof & Baer, 2011): The FFMQ-SF is a 24-item questionnaire that, just like the full 39-item FFMQ, measures five facets of mindfulness: observing, describing, acting with awareness, nonjudging and nonreactivity (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). All items are scored on a 5-point Likert-type scale ranging from ´never or rarely true´ (1) to ´very often or always true´ (5). Higher scores indicate more mindfulness. The Dutch FFMQ was developed by translation and back-translation of the original FFMQ and has shown adequate construct validity and test-retest reliability in patients with fibromyalgia (Veehof, ten Klooster, Taal, Westerhof & Bohlmeijer, 2011). The recently developed short form also show good model fit and reliability (Bohlmeijer et al., 2011);
6. Psychological inflexibility in Pain Scale (PIPS) (Wicksell et al, 2010; Trompetter et al., in preparation): The PIPS is a 12-item instrument measuring psychological inflexibility, the main concept in Acceptance and Commitment Therapy (Hayes et al., 2006). The scale consists of two subscales measuring avoidance (8 items) and cognitive fusion (4 items). All items have to be scored by participants on a 7-point Likert-type scale ranging from ´never true´ (1) to ´always true´ (7). Higher scores indicate greater psychological inflexibility. A recent study showed good model fit, good internal consistencies, and correlations with several related constructs (such as pain disability, life satisfaction and acceptance) ((Wicksell et al., 2010). The Dutch version of the PIPS also has good validity and reliability (Trompetter et al., in preparation);
7. Twente Values Scale (TVS): The TVS is recently developed at the Unversity of Twente from an ACT-perspective to measure values-based living, a core process of ACT. The scale consists of three subscales: ‘knowing personal values’, ‘living in accordance with personal values/committed action’ and ‘general evaluation of values-based life’. Every item can be answered on a 5-point Likert scale ranging from ‘not true at all’ (1) to ‘very much true’ (5). Preliminary analysis shows the TVS has good internal consistency and good construct validity;
8. Pain Catastrophizing Scale (PCS) (Sullivan, Bishop & Pivik, 1995; Crombez & Vlaeyen, 1996): The PCS is a 13-item questionnaire developed to measure pain catastrophizing. The scale consists of three subscales measuring ‘rumination’ (4 items), ‘magnification’ (3 items) and ‘helplessness’ (6 items). Answers can be given on a 5-point Likert Scale, ranging from ‘never’ (0) to ‘always’ (4). Item scores can be summed to a total score or can be calculated for the subscales separately. Internal consistency, test-retest reliability and construct validity are all good.
- TimepointsSix measurement moments:
1. Baseline (prior to start intervention);
2. During intervention; 4 weeks after start - short questionnaire);
3. During intervention; 8 weeks after start - short questionnaire);
4. Directly after end intervention (12 weeks after baseline);
5. 3-month follow-up;
6. 9-month follow-up (only for intervention conditions, not waiting list).
- Trial web siteN/A
- statusinclusion stopped: follow-up
- Sponsor/Initiator University of Twente, Dept. of Psychology, Health & Technology (PHT)
- Funding
(Source(s) of Monetary or Material Support)
University of Twente, Institute of Behavioural Science
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD9-okt-2012 - 22-okt-2012

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