Clinical trial NCT02369393: Efficacy of Two Internet Delivered Intervention Programs for Depression: Behavioral Activation vs Physical Activity
Official title: Treatment of Depression: Efficacy and Efficiency of Two Self-administered Online Intervention Protocols Based on Behavioral Activation and Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Internet based treatment
Depression
Efficacy
Cost-effectiveness
Behavioral Activation
Self-applied
Ecological Momentary Assessment
Physical Activity
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: University of Valencia
name: Universitat Politècnica de València
First posted: 2015-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical and cost-effectiveness of Behavioral Activation (BA) and Physical Activity (PA) for adults with major depressive disorder (MDD) or adjustment disorder with depressive symptomatology with a wait list control group (WL) in Spanish population.

Detailed description: Research shows that in 2030 (Mathers and Loncar, 2006) depression will become one of the three leading causes of disability. Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term.

Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.

Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness, but with similar levels of clinical efficacy and quality of care.

In Spain the trial will be carried out in a community sample, comparing the clinical and cost-effectiveness of BA or PA with WL for adults with major depressive disorder (MDD) and adjustment disorder with depressive symptomatology. Respondents will be followed until 6 months after baseline (measures will be taken at BL, 3 months, and 6 months).

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Meet DSM-IV diagnostic criteria for MDD and adjustment disorder confirmed by MINI International Neuropsychiatric Interview version 5.0 and SCID I
* A score of 5 or higher on the PHQ-9 screening questionnaire.

Exclusion Criteria:

* Current high risk for suicide according to the MINI Interview section C
* Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
* Currently receiving psychological treatment for depression in primary or specialised mental health care
* Being unable to comprehend the spoken and written language (Spanish)
* Not having access to a PC and fast Internet connection (i.e. broadband or comparable).

Primary outcomes:
measure: Change in Patient Health Questionnaire-9
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Beck Depression Inventory
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
Secondary outcomes:
measure: Change in the EQ-5D-5L (EuroQol)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Quality of Life (QLI)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Positive and Negative Affect Scale (PANAS)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Happiness Scale (Fordyce)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Satisfaction with Life Scale (SWLS, Diener)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Ryff Scale of Psychological Wellbeing
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Behavioral Activation for Depression Scale - Short Form (BADS-SF)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in the Environmental Reward Observation Scale (EROS)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
measure: Change in Beck Depression Inventory (BDI-II)
timeFrame: Change from baseline to 2 months, 5 months, and 8 months
Other outcomes:
measure: Eysenck Personality Questionnaire-Revised Short Form (Neuroticism subscale)
timeFrame: Baseline
measure: Credibility and expectancy questionnaire (CEQ)
timeFrame: 2 weeks
measure: Self concordance motivation (SCM)
timeFrame: 2 weeks
measure: Working Alliance Inventory (WAI-SF)
timeFrame: 3 weeks
measure: System usability scale (SUS)
timeFrame: 2 months
measure: Change in preferences for treatment scale (self-applied vs face to face)
timeFrame: Change from baseline to 2 months
measure: Satisfaction with the treatment
timeFrame: 2 months
measure: Change in the MINI International Neuropsychiatric Interview (M.I.N.I) version 5.0
timeFrame: Change from baseline to 2 months
measure: Change in Structured Clinical Interview (SCID-I) for Adjustment Disorders
timeFrame: Change from baseline to 2 months
measure: Attitudes towards Psychological Online Interventions Questionnaire (APOI)
timeFrame: Baseline
measure: Semi-structured interview about users´ intervention experience
timeFrame: 2 months
Locations:
city: Castelló de la Plana
country: Spain
facility: University Jaume I
Study officials:
affiliation: Universitat Jaume I;CIBERObn ISC III, Spain
name: Cristina Botella, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat de Valencia; CIBERObn ISC III, Spain
name: Rosa Baños, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson G, Cuijpers P. Internet-based and other computerized psychological treatments for adult depression: a meta-analysis. Cogn Behav Ther. 2009;38(4):196-205. doi: 10.1080/16506070903318960.
citation: Cavanagh K, Shapiro DA. Computer treatment for common mental health problems. J Clin Psychol. 2004 Mar;60(3):239-51. doi: 10.1002/jclp.10261.
citation: Coffman SJ, Martell CR, Dimidjian S, Gallop R, Hollon SD. Extreme nonresponse in cognitive therapy: can behavioral activation succeed where cognitive therapy fails? J Consult Clin Psychol. 2007 Aug;75(4):531-41. doi: 10.1037/0022-006X.75.4.531.
citation: Davidson TM, Yuen EK, Felton JW, McCauley J, Gros KS, Ruggiero KJ. Feasibility assessment of a brief, web-based behavioral activation intervention for adolescents with depressed mood. Int J Psychiatry Med. 2014;48(1):69-82. doi: 10.2190/PM.48.1.f.
citation: Sudak DM, Majeed MH, Youngman B. Behavioral activation: a strategy to enhance treatment response. J Psychiatr Pract. 2014 Jul;20(4):269-75. doi: 10.1097/01.pra.0000452563.05911.c9.
citation: Cuijpers P, Donker T, van Straten A, Li J, Andersson G. 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. Psychol Med. 2010 Dec;40(12):1943-57. doi: 10.1017/S0033291710000772. Epub 2010 Apr 21.
citation: Soucy Chartier I, Provencher MD. Behavioural activation for depression: efficacy, effectiveness and dissemination. J Affect Disord. 2013 Mar 5;145(3):292-9. doi: 10.1016/j.jad.2012.07.023. Epub 2012 Aug 9.
citation: Churchill R, Moore TH, Furukawa TA, Caldwell DM, Davies P, Jones H, Shinohara K, Imai H, Lewis G, Hunot V. 'Third wave' cognitive and behavioural therapies versus treatment as usual for depression. Cochrane Database Syst Rev. 2013 Oct 18;(10):CD008705. doi: 10.1002/14651858.CD008705.pub2.
citation: Dimidjian S, Barrera M Jr, Martell C, Munoz RF, Lewinsohn PM. The origins and current status of behavioral activation treatments for depression. Annu Rev Clin Psychol. 2011;7:1-38. doi: 10.1146/annurev-clinpsy-032210-104535.
citation: Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037/0022-006X.74.4.658.
citation: Fitzsimons CF, Baker G, Gray SR, Nimmo MA, Mutrie N; Scottish Physical Activity Research Collaboration (SPARColl). Does physical activity counselling enhance the effects of a pedometer-based intervention over the long-term: 12-month findings from the Walking for Wellbeing in the west study. BMC Public Health. 2012 Mar 19;12:206. doi: 10.1186/1471-2458-12-206.
citation: Azevedo Da Silva M, Singh-Manoux A, Brunner EJ, Kaffashian S, Shipley MJ, Kivimaki M, Nabi H. Bidirectional association between physical activity and symptoms of anxiety and depression: the Whitehall II study. Eur J Epidemiol. 2012 Jul;27(7):537-46. doi: 10.1007/s10654-012-9692-8. Epub 2012 May 24.
citation: Loprinzi PD, Mahoney S. Concurrent occurrence of multiple positive lifestyle behaviors and depression among adults in the United States. J Affect Disord. 2014 Aug;165:126-30. doi: 10.1016/j.jad.2014.04.073. Epub 2014 May 5.
citation: Goodwin RD. Association between physical activity and mental disorders among adults in the United States. Prev Med. 2003 Jun;36(6):698-703. doi: 10.1016/s0091-7435(03)00042-2.
citation: Harvey SB, Hotopf M, Overland S, Mykletun A. Physical activity and common mental disorders. Br J Psychiatry. 2010 Nov;197(5):357-64. doi: 10.1192/bjp.bp.109.075176.
citation: Hollon SD, Ponniah K. A review of empirically supported psychological therapies for mood disorders in adults. Depress Anxiety. 2010 Oct;27(10):891-932. doi: 10.1002/da.20741.
citation: Jancey JM, Lee AH, Howat PA, Clarke A, Wang K, Shilton T. The effectiveness of a physical activity intervention for seniors. Am J Health Promot. 2008 May-Jun;22(5):318-21. doi: 10.4278/ajhp.22.5.318.
citation: Johansson R, Andersson G. Internet-based psychological treatments for depression. Expert Rev Neurother. 2012 Jul;12(7):861-9; quiz 870. doi: 10.1586/ern.12.63.
citation: King AC, Friedman R, Marcus B, Castro C, Napolitano M, Ahn D, Baker L. Ongoing physical activity advice by humans versus computers: the Community Health Advice by Telephone (CHAT) trial. Health Psychol. 2007 Nov;26(6):718-27. doi: 10.1037/0278-6133.26.6.718.
citation: Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
citation: Mead GE, Morley W, Campbell P, Greig CA, McMurdo M, Lawlor DA. Exercise for depression. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD004366. doi: 10.1002/14651858.CD004366.pub4.
citation: Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040.
citation: Mota-Pereira J, Silverio J, Carvalho S, Ribeiro JC, Fonte D, Ramos J. Moderate exercise improves depression parameters in treatment-resistant patients with major depressive disorder. J Psychiatr Res. 2011 Aug;45(8):1005-11. doi: 10.1016/j.jpsychires.2011.02.005. Epub 2011 Mar 5.
citation: Pinninti NR, Madison H, Musser E, Rissmiller D. MINI International Neuropsychiatric Schedule: clinical utility and patient acceptance. Eur Psychiatry. 2003 Nov;18(7):361-4. doi: 10.1016/j.eurpsy.2003.03.004.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Konig HH, Born A, Gunther O, Matschinger H, Heinrich S, Riedel-Heller SG, Angermeyer MC, Roick C. Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with anxiety disorders. Health Qual Life Outcomes. 2010 May 5;8:47. doi: 10.1186/1477-7525-8-47.
citation: Newman MG, Szkodny LE, Llera SJ, Przeworski A. A review of technology-assisted self-help and minimal contact therapies for anxiety and depression: is human contact necessary for therapeutic efficacy? Clin Psychol Rev. 2011 Feb;31(1):89-103. doi: 10.1016/j.cpr.2010.09.008. Epub 2010 Oct 14.
citation: Plonczynski DJ. Measurement of motivation for exercise. Health Educ Res. 2000 Dec;15(6):695-705. doi: 10.1093/her/15.6.695.
citation: Stanton R, Reaburn P. Exercise and the treatment of depression: a review of the exercise program variables. J Sci Med Sport. 2014 Mar;17(2):177-82. doi: 10.1016/j.jsams.2013.03.010. Epub 2013 Apr 18.
citation: Mammen G, Faulkner G. Physical activity and the prevention of depression: a systematic review of prospective studies. Am J Prev Med. 2013 Nov;45(5):649-57. doi: 10.1016/j.amepre.2013.08.001.