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Self Help Plus: study protocol for a cluster-randomised controlled trial of guided self-help with South Sudanese refugee women in Uganda

  • F. L. Brown (a1) (a2), K. Carswell (a3), J. Augustinavicius (a4), A. Adaku (a5) (a6), M. R. Leku (a5), R. G. White (a7), P. Ventevogel (a8), C. S. Kogan (a9), C. García-Moreno (a10), R. A. Bryant (a11), R. J. Musci (a4), M. van Ommeren (a3) and W. A. Tol (a4) (a5)...

Abstract

Background.

Exposure to armed conflict and forced displacement constitute significant risks for mental health. Existing evidence-based psychological interventions have limitations for scaling-up in low-resource humanitarian settings. The WHO has developed a guided self-help intervention, Self Help Plus (SH+), which is brief, implemented by non-specialists, and designed to be delivered to people with and without specific mental disorders. This paper outlines the study protocol for an evaluation of the SH+ intervention in northern Uganda, with South Sudanese refugee women.

Methods.

A two-arm, single-blind cluster-randomised controlled trial will be conducted in 14 villages in Rhino Camp refugee settlement, with at least 588 women experiencing psychological distress. Villages will be randomly assigned to receive either SH+ with enhanced usual care (EUC), or EUC alone. SH+ is a five-session guided self-help intervention delivered in workshops with audio-recorded materials and accompanying pictorial guide. The primary outcome is reduction in overall psychological distress over time, with 3 months post-treatment as the primary end-point. Secondary outcomes are self-defined psychosocial concerns, depression and post-traumatic stress disorder symptoms, hazardous alcohol use, feelings of anger, interethnic relations, psychological flexibility, functional impairment and subjective wellbeing. Psychological flexibility is a hypothesised mediator, and past trauma history and intervention attendance will be explored as potential moderators.

Discussion.

This trial will provide important information on the effectiveness of a scalable, guided self-help intervention for improving psychological health and wellbeing among people affected by adversity.

Trial Registration:

ISRCTN50148022; registered 13/03/2017.

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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Corresponding author

*Address for correspondence: W.A. Tol, HealthRight International Uganda, Plot 855, Mawanda Rd, PO Box 20129, Nakawa, Kampala, Uganda. (Email: wtol@pcaf.org)

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References

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A-Tjak, J, Davis, M, Morina, N, Powers, M, Smits, J, Emmelkamp, P (2015). A meta-analysis of the efficacy of Acceptance and Commitment Therapy for clinically relevant mental and physical health problems. Psychotherapy and Psychosomatics 84, 3036.
Adaku, A, Okello, J, Lowry, B, Kane, JC, Alderman, S, Musisi, S, Tol, WA (2016). Mental health and psychosocial support for South Sudanese refugees in northern Uganda: a needs and resource assessment. Conflict and Health 10, 18.
Andrews, G, Cuijpers, P, Craske, MG, Mcevoy, P, Titov, N (2010). Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS ONE 5, e13196.
Bech, P, Olsen, LR, Kjoller, M, Rasmussen, NK (2003). Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five well-being scale. International Journal of Methods in Psychiatric Research 12, 8591.
Bernal, G, Sáez-Santiago, E (2006). Culturally centered psychosocial interventions. Journal of Community Psychology 34, 121132.
Betancourt, TS, Mcbain, R, Newnham, EA, Akinsulure-Smith, AM, Brennan, RT, Weisz, JR, Hansen, NB (2014). A behavioral intervention for war-affected youth in Sierra Leone: a randomized controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry 53, 12881297.
Blanchet, K, Sistenich, V, Ramesh, A, Frison, S, Warren, E, Hossain, M, Knight, A, Lewis, C, Smith, J, Woodward, A, Dahab, M, Pantuliano, S, Roberts, B (2013). An evidence review of research on health interventions in humanitarian crises. London: London School of Hygiene and Tropical Medicine/Harvard School of Public Health.
Bond, FW, Hayes, SC, Baer, RA, Carpenter, KM, Guenole, N, Orcutt, HK, Waltz, T, Zettle, RD (2011). Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behavior Therapy 42, 676688.
Campbell, MK, Elbourne, DR, Altman, DG (2004). CONSORT statement: extension to cluster randomised trials. The British Medical Journal 328, 702708.
Castro, FG, Barrera, M Jr., Martinez, CR Jr. (2004). The cultural adaptation of prevention interventions: resolving tensions between fidelity and fit. Prevention Science 5, 4145.
Castro, FG, Barrera, M Jr., Steiker, LKH (2010). Issues and challenges in the design of culturally adapted evidence-based interventions. Annual Review of Clinical Psychology 6, 213239.
Cavanagh, K, Strauss, C, Forder, L, Jones, F (2014). Can mindfulness and acceptance be learnt by self-help? A systematic review and meta-analysis of mindfulness and acceptance-based self-help interventions. Clinical Psychology Review 34, 118129.
Cheong, J, Mackinnon, DP, Khoo, ST (2003). Investigation of mediational processes using parallel process latent growth curve modeling. Structural Equation Modeling 10, 238262.
Craig, P, Dieppe, P, Macintyre, S, Michie, S, Nazareth, I, Petticrew, M (2008). Developing and evaluating complex interventions: the new Medical Research Council guidance. The British Medical Journal 337, a1655.
Cuijpers, P, Donker, T, Van Straten, A, Li, J, Andersson, G (2010). Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies. Psychological Medicine 40, 19431957.
Cuijpers, P, Muñoz, RF, Clarke, GN, Lewinsohn, PM (2009). Psychoeducational treatment and prevention of depression: the ‘coping with depression’ course thirty years later. Clinical Psychology Review 29, 449458.
Czachowski, S, Seed, P, Schofield, P, Ashworth, M (2011). Measuring psychological change during cognitive behaviour therapy in primary care: a Polish study using ‘PSYCHLOPS’ (Psychological Outcome Profiles). PLoS ONE 6, e27378.
Dong, N, Maynard, R (2013). Powerup!: a tool for calculating minimum detectable effect sizes and minimum required sample sizes for experimental and quasi-experimental design studies. Journal of Research on Educational Effectiveness 6, 2467.
Dua, T, Barbui, C, Clark, N, Fleischmann, A, Poznyak, V, Van Ommeren, M, Yasamy, MT, Ayuso-Mateos, JL, Birbeck, GL, Drummond, C (2011). Evidence-based guidelines for mental, neurological, and substance use disorders in low- and middle-income countries: summary of WHO recommendations. PLoS Medicine 8, e1001122.
Duncan, TE, Duncan, SC (2004). An introduction to latent growth curve modeling. Behavior Therapy 35, 333363.
Epping-Jordan, JE, Harris, R, Brown, FL, Carswell, K, Foley, C, Garcia-Moreno, C, Kogan, C, Van Ommeren, M (2016). Self-Help Plus (SH+): a new WHO stress management package. World Psychiatry 15, 295296.
Fledderus, M, Bohlmeijer, ET, Pieterse, ME, Schreurs, KMG (2012). Acceptance and commitment therapy as guided self-help for psychological distress and positive mental health: a randomized controlled trial. Psychological Medicine 42, 485495.
Furukawa, TA, Noma, H, Caldwell, DM, Honyashiki, M, Shinohara, K, Imai, H, Chen, P, Hunot, V, Churchill, R (2014). Waiting list may be a nocebo condition in psychotherapy trials: a contribution from network meta-analysis. Acta Psychiatrica Scandinavica 130, 181192.
Harsha, A, Kulkarni, A (2014). Mental health needs assessment of South Sudanese refugees in the West Nile Region, Uganda: A desk review (unpublished report), Kampala, Uganda, Peter C Alderman Foundation.
Hayes, SC, Luoma, JB, Bond, FW, Masuda, A, Lillis, J (2006). Acceptance and commitment therapy: model, processes and outcomes. Behaviour Research and Therapy 44, 125.
Héðinsson, H, Kristjánsdóttir, H, Ólason, , Sigurðsson, JF (2012). A validation and replication study of the patient-generated measure PSYCHLOPS on an Icelandic clinical population. European Journal of Psychological Assessment 29, 8995.
Inter-Agency Standing Committee (2007). IASC Guidelines on Mental Health and Psychosocial Support in Emergency Settings. Inter-Agency Standing Committee: Geneva.
Jeffcoat, T, Hayes, SC (2012). A randomized trial of ACT bibliotherapy on the mental health of K-12 teachers and staff. Behaviour Research and Therapy 50, 571579.
Kane, JC, Adaku, A, Nakku, J, Odokonyero, R, Okello, J, Musisi, S, Augustinavicius, J, Greene, MC, Alderman, S, Tol, WA (2016). Challenges for the implementation of World Health Organization guidelines for acute stress, PTSD, and bereavement: a qualitative study in Uganda. Implementation Science 11, 36.
Kane, JC, Ventevogel, P, Spiegel, P, Bass, JK, Van Ommeren, M, Tol, WA (2014). Mental, neurological, and substance use problems among refugees in primary health care: analysis of the Health Information System in 90 refugee camps. BMC Medicine 12, 228.
Kashdan, TB, Morina, N, Priebe, S (2009). Post-traumatic stress disorder, social anxiety disorder, and depression in survivors of the Kosovo War: experiential avoidance as a contributor to distress and quality of life. Journal of Anxiety Disorders 23, 185196.
Kessler, RC, Green, JG, Gruber, MJ, Sampson, NA, Bromet, E, Cuitan, M, Furukawa, TA, Gureje, O, Hinkov, H, Hu, C-Y, Lara, C, Lee, S, Mneimneh, Z, Myer, L, Oakley-Browne, M, Posada-Villa, J, Sagar, R, Viana, MC, Zaslavsky, AM (2010). Screening for serious mental illness in the general population with the K6 screening scale: results from the WHO World Mental Health (WMH) survey initiative. International Journal of Methods in Psychiatric Research 19, 422.
Kessler, RC, Howes, MJ, Walters, EE, Hiripi, E, Normand, S-LT, Colpe, LJ, Zaslavsky, AM, Manderscheid, RW, Epstein, JF, Gfroerer, JC, Barker, PR (2003). Screening for serious mental illness in the general population. Archives of General Psychiatry 60, 184189.
Kim, G, Torbay, R, Lawry, L (2007). Basic health, women's health, and mental health among internally displaced persons in Nyala Province, South Darfur, Sudan. American Journal of Public Health 97, 353.
Kim, N, Conceição, P (2010). The economic crisis, violent conflict, and human development. International Journal of Peace Studies, 15, 2943.
Kroenke, K, Spitzer, RL, Williams, JBW (2001). The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine 16, 606613.
Lang, AJ, Stein, MB (2005). An abbreviated PTSD checklist for use as a screening instrument in primary care. Behaviour Research and Therapy 43, 585594.
Lundgren, T, Dahl, J, Melin, L, Kies, B (2006). Evaluation of acceptance and commitment therapy for drug refractory epilepsy: a randomized controlled trial in South Africa. Epilepsia 47, 21732179.
Miller, KE, Jordans, MJ (2016). Determinants of children's mental health in war-torn settings: translating research into action. Current Psychiatry Reports 18, 58.
Miller, KE, Rasmussen, A (2010). War exposure, daily stressors, and mental health in conflict and post-conflict settings: bridging the divide between trauma-focused and psychosocial frameworks. Social Science and Medicine 70, 716.
Mollica, RF, Caspi-Yavin, Y, Bollini, P, Truong, T, Tor, S, Lavelle, J (1992). The Harvard Trauma Questionnaire: validating a cross-cultural instrument for measuring torture, trauma, and posttraumatic stress disorder in Indochinese refugees. Journal of Nervous and Mental Disease 180, 111116.
Murray, LK (2014). A common elements treatment approach for adult mental health problems in low- and middle-income countries. Cognitive and Behavioral Practice 21, 111123.
Murray, LK, Tol, W, Jordans, M, Zangana, GS, Amin, AM, Bolton, P, Bass, J, Bonilla-Escobar, FJ, Thornicroft, G (2014). Dissemination and implementation of evidence based, mental health interventions in post conflict, low resource settings. Intervention 12, 94112.
Muthén, LK, Muthén, BO (1998–2017). Mplus User's Guide. Muthén & Muthén: Los Angeles, CA.
Nakimuli-Mpungu, E, Alderman, S, Kinyanda, E, Allden, K, Betancourt, TS, Alderman, JS, Pavia, A, Okello, J, Nakku, J, Adaku, A (2013). Implementation and scale-up of psycho-trauma centers in a post-conflict area: a case study of a private–public partnership in northern Uganda. PLoS Medicine 10, e1001427.
Norris, FH, Friedman, MJ, Watson, PJ (2002). 60 000 disaster victims speak: Part II. Summary and implications of the disaster mental health research. Psychiatry 65, 240260.
Nyirenda, M, Newell, M-L, Mugisha, J, Mutevedzi, PC, Seeley, J, Scholten, F, Kowal, P (2013). Health, wellbeing, and disability among older people infected or affected by HIV in Uganda and South Africa. Global Health Action 6, 19201.
OECD (2016). Perspectives on Global Development 2017: International Migration in a Shifting World, OECD Publishing, Paris, https://doi.org/10.1787/persp_glob_dev-2017-en.
Prince, M, Patel, V, Saxena, S, Maj, M (2007). No health without mental health. The Lancet 370, 859877.
Prochaska, JJ, Sung, HY, Max, W, Shi, Y, Ong, M (2012). Validity study of the K6 scale as a measure of moderate mental distress based on mental health treatment need and utilization. International Journal of Methods in Psychiatric Research 21, 8897.
Robinson, S, Godfrey, E, Ashworth, M, Parmentier, H, Wright, K, Matthews, V, Shepherd, M, Christey, J (2004). A client-generated psychometric instrument: the development of ‘PSYCHLOPS’. Counselling and Psychotherapy Research 4, 2731.
Saxena, S, Thornicroft, G, Knapp, M, Whiteford, H (2007). Resources for mental health: scarcity, inequity, and inefficiency. The Lancet 370, 878889.
Schafer, JL, Graham, JW (2002). Missing data: our view of the state of the art. Psychological Methods 7, 147.
Silove, D, Mohsin, M, Tay, AK, Steel, Z, Tam, N, Savio, E, Da Costa, ZM, Rees, S (2017). Six-year longitudinal study of pathways leading to explosive anger involving the traumas of recurrent conflict and the cumulative sense of injustice in Timor-Leste. Social Psychiatry and Psychiatric Epidemiology 52, 114.
Silove, D, Rees, S, Tam, N, Mohsin, M, Tay, AK, Tol, W (2015). Prevalence and correlates of explosive anger among pregnant and post-partum women in post-conflict Timor-Leste. British Journal of Psychiatry 1, 3441.
Statacorp (2015). Stata Statistical Software: Release 14. StataCorp LP: College Station, TX.
Steel, Z, Chey, T, Silove, D, Marnane, C, Bryant, RA, Van Ommeren, M (2009). Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA 302, 537549.
Stewart, C, White, RG, Ebert, B, Mays, I, Nardozzi, J, Bockarie, H (2016). A preliminary evaluation of Acceptance and Commitment Therapy (ACT) training in Sierra Leone. Journal of Contextual Behavioral Science 5, 1622.
Tol, WA, Augustinavicius, J, Carswell, K, Brown, FL, Adaku, A, Leku, MR, Garcia-Moreno, C, Ventevogel, P, White, RG, Van Ommeren, M (2018a). Translation, adaptation, and pilot of a guided self-help intervention to reduce psychological distress in South Sudanese refugees in Uganda. Global Mental Health, 5.
Tol, WA, Augustinavicius, J, Carswell, K, Leku, MR, Adaku, A, Brown, FL, Garcia-Moreno, C, Ventevogel, P, White, RG, Kogan, C, Van Ommeren, M (2018b). Feasibility of a guided self-help intervention to reduce psychological distress in South Sudanese refugee women in Uganda. World Psychiatry 17, 234235.
Tol, WA, Barbui, C, Van Ommeren, M (2013). Management of acute stress, PTSD, and bereavement: WHO recommendations. JAMA 310, 477478.
Trompetter, HR, Bohlmeijer, ET, Veehof, MM, Schreurs, KM (2015). Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial. Journal of Behavioral Medicine 38, 6680.
United Nations High Commissioner for Refugees (2013). Operational Guidance for Mental Health and Psychosocial Support Programming in Refugee Operations. UNHCR: Geneva.
United Nations High Commissioner for Refugees (2017). Global Trends: Forced Displacement in 2016. UNHCR: Geneva.
Van Ommeren, M, Sharma, B, Thapa, S, Makaju, R, Prasain, D, Bhattarai, R, De Jong, J (1999). Preparing instruments for transcultural research: use of the translation monitoring form with Nepali-speaking Bhutanese refugees. Transcultural Psychiatry 36, 285301.
Ventevogel, P, Jordans, M, Reis, R, De Jong, J (2013). Madness or sadness? Local concepts of mental illness in four conflict-affected African communities. Conflict and Health 7, 3.
Ventevogel, P, Van Ommeren, M, Schilperoord, M, Saxena, S (2015). Improving mental health care in humanitarian emergencies. Bulletin of the World Health Organization 93, 666666.
White, R, Ebert, B (2014). Working globally, thinking locally: providing psychosocial intervention training in Sierra Leone. Clinical Psychology Forum 258, 4145.
White, RG, Gregg, J, Batten, S, Hayes, LL, Kasujja, R (2017). Contextual behavioral science and global mental health: synergies and opportunities. Journal of Contextual Behavioral Science 6, 245251.
World Health Organisation (2005). WHO Multi-country Study on Women's Health and Domestic Violence against Women. WHO: Geneva.
World Health Organisation (2010). Measuring Health and Disability: Manual for WHO Disability Assessment Schedule (WHODAS 2.0). WHO: Geneva.
World Health Organisation (2015 a). Comparative Effectiveness of Different Formats of Psychological Treatments for Depressive Disorder. WHO: Geneva.
World Health Organisation (2015 b). Thinking Healthy: A Manual for Psychological Management of Perinatal Depression. WHO: Geneva.
World Health Organisation (2016). Problem Management Plus (PM+): Individual Psychological Help for Adults Impaired by Distress in Communities Exposed to Adversity. WHO: Geneva.

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