Sothera Chim, Taing Sopheap*** Chronic pain as a relevant target for the rehabilitation of torture survivors: implementation of a pain school intervention in Cambodia and outcome in two pilot studies Uwe Harlacher* Peter Polatin** Sothera Chim, Taing Sopheap*** * Nunca Mas, Medicines Sans Frontiers (currently Iraq) ** George Washington University, Harvard Program in Refugee Trauma, Boston, MA, USA *** Transcultural Psychosocial Organization (TPO), Cambodia

Project History 1 Cooperation since 2010 between the Danish RCT - Rehabilitation and Research Center for Torture Survivors (renamed “DIGNITY” 2012) and the Transcultural Psychosocial Organization (TPO) Cambodia in addressing chronic pain among TPO clients Development of a group based 10 session “Khmer Pain School” in an interactive training process, ca. 12 TPO facilitators trained (acting in pairs) Outcome tested in 2 pilot (pre-post comparison) studies, using mainly Disability Rating Index (DRI) and Brief Pain Inventory (BPI) items as outcome measures; experimentation with alternative measurement method for DRI items (“blue cloth method”, illustration below) Pilot 1 (2012): items only translated, outcome analysis for BPI on item level, some study-mistakes made, e.g. drop-out analysis not possible

Project History 2 Pilot 2 (2013/14): items had been retranslated, outcome analysis for BPI on scale level, much less study-mistakes made Qualitative analyses: ca. 50% of facilitators initially skeptical regarding expected outcome, almost only positive feedback from clients A high quality randomized controlled (RCT) outcome study, also including other measures (e.g. on PTSD), conducted 2015 to, according to contract, April 2016 Project aborted by “DIGNITY” in December 2015, the publication of the available results are however under preparation

“Blue cloth method” for measuring of DRI - items Instead of the usual 0-100 VAS-scale, there are 5 response categories, to be answered by placing a bamboo stick in the corresponding pocket. This method has been used in the 2 pilot trials. In the RCT, the 5 category response scale has been used in a traditional paper-pencil format.

Pilot study 1 (n = 34): Functional disability - DRI-index (mean of 11 items, scale 1-5, “blue cloth method”) Mean/Sd pre and post treatment, t/p-values for paired sample t-test and Cohen’s effect size (d). Number of clients improving /deteriorating with at least 20% (on item-level equaling one category). High scores = more, low scores = less functional disability. Mean /Sd pre /Sd post t/p d N improved deteriorated DRI- index 3.40 .63 2.54 .62 9.30 <.000 1.38 16 2

Pilot study 1 (n = 34): Pain related (most BPI) items Mean pre and post treatment, t/p-values for paired sample t-test. Number of clients improving (+)/deteriorating (-) with at least 30% (on item-level equaling 3 categories on the 0-10 response scale); for item 11: response scale not categories but Visual Analogue Scale (VAS). High scores = more, low scores = less difficulties. Item Mean pre post t p < + - 1. Worst pain in the last 24 h 8.24 5.03 7.72 .000 19 2. Least pain in the last 24 h 4.79 2.68 5.51 15 1 3. Pain on the average 4.91 3.06 4.65 13 4. Pain right now 5.85 4.35 3.33 .002 11 3 5. General activity 6.56 4.18 5.46 14 6. Mood 5.74 4.21 2 7. Walking 4.24 8. Relations with other people 5.26 3.79 3.57 .001 9. Sleep 4.26 3.09 2.64 .013 7 10. Enjoyment of life 4.56 4.19 11. Mean pain last 24 h (VAS) 5.94 3.76 6.89

Pilot study 2 (n=18): BPI (Pain intensity & interference) and DRI scores (“blue cloth method”) Mean/Sd for outcome variables pre and post treatment, t/p-values for paired sample t-tests and Cohen’s effect sizes (d). Internal consistency of each measure (Cronbach’s alpha) and number of client’s reliably changed sensu Jacobson & Truax Mean/Sd pre Mean/ Sd post t/p d Al-pha N im-proved N dete- riorated BPI Pain intensity (mean of first 4 items, scale 0-10) 8.60 .99 4.67 1.24 10.43 <.000 3.50 .86 17 BPI Pain interference (mean of last 7 items, scale 0-10) 8.61 1.33 4.07 1.02 12.81 3.83 .92 18 DRI- index (mean of 11 items, scale 1-5) 3.17 .63 2.12 .55 7.07 1.78 .87 15 Total score (mean of the above 3 measures, scale 0-10) 7.55 1.03 3.85 1.00 12.65 3.65 .68 16

Outline of the randomized controlled trial and its results 1 Study sample: multiple tortured/ traumatized survivors of the Khmer Rouge regime, suffering from both chronic pain and at least moderate PTSD A high statistical power (total n = 113, low drop-out-rate) and high data quality (low rate of missing data) was achieved Unlike in the pilot trials, the Pain school was implemented in a highly condensed format during one week (mainly due to practical constraints)

Outline of the randomized controlled trial and its results 2 A significant improvement in DRI and BPI as well as on non pain related symptoms e.g. PTSD and depression, is observed As also the untreated control group improves somewhat, the relative effect sizes are more modest than suggested by the pilot trials As in the previous pilot studies, no major moderators (e.g. age and gender) for treatment outcome are observed and no indications for that the treatment could have negative side effects Until 6 month follow up, most of the gains disappear. The insufficient maintenance is most probable due to the too condensed treatment format.

Conclusions 1 The long-term cooperation enabled transfer of knowledge and clinical know-how within the previously neglected chronic pain problem area From early on, interactive training enabled a “build in” cultural adaptation of the Pain School intervention The stepwise “evolution” approach improved also the ability to conduct empirical research, starting with a simple, imperfect pilot study and finally enabling the conduction of a high quality randomized controlled outcome trial (RCT)

Conclusions 2 The data indicate that chronic pain is a target-problem that is effectively treatable with a resource saving group based psychoeducational intervention The RCT showing that a pain intervention also ameliorates non-pain problems like PTSD, talks in favor of the hypothesis that chronic pain is a problem “in its own right” (and is not only “psychosomatic”/secondary to PTSD and/or depression)

Discussion and comments The positive sides of the project history illustrate the beneficial effects of reliable long term cooperation/funding The premature abortion of the project (end of 2015, Danish staff being dismissed) illustrates the detrimental effects of unreliable funding, e.g. inability to determine treatment integrity by inspection of video-recorded pain school sessions The available data should justify investment in a continued research effort aiming at increasing the maintenance of Pain School gains by applying a treatment format less condensed as the one applied in the outlined RCT In order to assist such an effort by a reliable funder and also in order to promote the treatment of chronic pain in general, the “Khmer Pain School Manual” will be made freely accessible as a part of the publication of the available study results