|- candidate number||14168|
|- NTR Number||NTR3775|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jan-2013|
|- Secondary IDs|| |
|- Public Title||Gelukkig ondanks pijn: Een interventie op het internet voor chronische pijn patiŽnten.|
|- Scientific Title||Dealing with pain: An intervention on the internet for people suffering from chronic pain.|
|- hypothesis||Are a positive psychology and a self-management intervention, equally effective in increasing quality of life and decreasing psychological distress and pain disability, in chronic pain patients, in comparison to a waiting-list control group?
Hypotheses: 1) Both interventions will be effective in decreasing psychological distress and pain disability, and increasing quality of life.
2)The positive psychology intervention has a significantly larger effect on optimism, self-compassion, and mood than the self-management intervention. |
|- Healt Condition(s) or Problem(s) studied||Chronic pain|
|- Inclusion criteria||1. Chronic pain in arms, neck, back, or legs longer than 6 months;|
2. Access to the internet.
|- Exclusion criteria||1. Acute pain complaints;|
2. Suffer of pain that can increase as a consequence of activity (e.g. spinal stenosis);
3. Be bound to a wheel chair;
4. Have planned any surgical treatment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||25-jun-2012|
|- planned closingdate||30-apr-2013|
|- Target number of participants||300|
|- Interventions||Both interventions last 8 weeks and have a similar format, starting with a brief educational module on the theme of the week, and theme-specific exercises.
The positive psychology program consists of the following themes: self-compassion (week 1 & 2), identifying three good things during a day (week 3), savoring (week 4 & 5), best possible self (week 6 & 7).
The self-management program is a translation of a Swedish program which consists of elements of cognitive-behavioural therapy. The following themes will be discussed: Identifying situations in which the pain is higher than normal (week 1), relaxation exercises (week 1-4), exercise and strech exercises (week 2), planning daily activities (week 3 -7), working with negative thoughts (week 3), accepting thoughts (week 4), mindfulness (week 5), saying no (week 6), and problem solving (week 7).
During week 8 of both interventions a maintenance plan will be made. Participants are encouraged to do their exercises daily. To keep track of progress and increase commitment participants will be emailed every week, and telephoned every two weeks.
The control group will be a waiting list control group.
|- Primary outcome||1. Quality of life - SWLS;|
2. Pain disability - PDI;
3. Pain catastrophizing - PCS.
|- Secondary outcome||1. Optimism - LOT-R;|
2. Savoring - SBI;
3. Self-compassion - SCS;
4. Anxiety/depression - HADS;
5. Perservative thinking - PTQ;
6. Illness cognitions - ICQ;
7. Mood - PANAS;
8. Pain intensity - visual analogue scales;
9. Expectancy and credibility of the intervention.
|- Timepoints||Outcome variabels will be measured before, after, and 6-months after the intervention.|
Process variables will be measured weekly.
|- Trial web site||www.gelukkigondankspijn.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. Elke Smeets|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Elke Smeets|
|- Sponsor/Initiator ||University Maastricht (UM), Faculty of Psychology and Neuroscience|
(Source(s) of Monetary or Material Support)
|NWO (VIDI grant)|
|- Brief summary||The present study will test the effectivity of a newly developed positive psychology intervention for chronic pain patients and will compare it to an existing self-management program, and a waiting list control group. Interventions are delivered over the internet.|
|- Main changes (audit trail)|
|- RECORD||3-jan-2013 - 12-jan-2013|