Murad HM et al: The New Evidence Pyramid (http://www.isehc.net/wp-content/uploads/2011/12/October-2015.pdf)
5
:
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Murad HM et al: The New Evidence Pyramid (http://www.isehc.net/wp-content/uploads/2011/12/October-2015.pdf)
5
:
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R C T ...
...
R C T ...
...
. 97 7 2 32GRADE . 65 , 2015.
Guyatt G et al: J Clin Epidemiol. 2011 Apr;64(4):383-94.
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( ) 7
!
!
!
!
!
!
Chapter 8: Assessing risk of bias in included studies (http://www.cochrane.org/handbook)
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CBT RCT
• $VJKQFSTFUBM
)JHIRVBMJUZͳ$#5ͷ3$5গͳ͍
Ҏ߱
Ҏલɿ
– ਓͷ͏ͭපෆ҆ʹର͢Δ$#5ͷ3$5݅
• ରর܈5"6
8-
QJMMQMBDFCPʹݶఆ
– ཚੜ
ׂΓ͚ͷӅณԽ
ධՁऀͷݕԽ
ΞτΧϜଌ
ఆͷશੑ *55Λ࣮ࢪ͍ͯ͠Δ͔ʣΛͭΛ९क͍ͯ͠Ε
IJHIRVBMJUZͱஅ
Cuijpers, P., Cristea, I. A., Karyotaki, E., Reijnders, M., & Huibers, M. J. (2016). How effecMve are cogniMve behavior
therapies for major depression and anxiety disorders? A meta-analyMc update of the evidence. World Psychiatry, 15(3),
245-258.
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CBT
• $#5͕ΰʔϧυελϯμʔυͱೝΊΒΕͳ͍
• $#5ݱঢ়Ͱؒҧ͍ͳ͘ΰʔϧυελϯμʔυ
Leichsenring, F., & Steinert, C. (2017). Is cogniMve behavioral therapy the gold
standard for psychotherapy?: the need for plurality in treatment and research.
Jama, 318(14), 1323-1324.
David, D., Cristea, I., & Hofmann, S. G. (2018). Why cogniMve behavioral therapy is the current
gold standard of psychotherapy. FronMers in psychiatry, 9, 4.
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1.
2.
3.
( TAU ,
4.
5.
6. Allegiance (
Leichsenring, F., & Steinert, C. (2017). Is cogniMve behavioral therapy the gold standard for
psychotherapy?: the need for plurality in treatment and research. Jama, 318(14), 1323-1324.
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CBT
- CBT (RCT )
- CBT
CBT
-
(
-
- TAU TAU
David, D., Cristea, I., & Hofmann, S. G. (2018). Why cogniMve behavioral therapy is the current
gold standard of psychotherapy. FronMers in psychiatry, 9, 4.
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- CBT RCT
- CBT
-
de Abreu Costa, M., de Oliveira, G. S. D. A., Tacon-Ramos, T., Manfro, G. G., & Salum, G. A. (2019). Anxiety and stress-related disorders and
mindfulness-based intervenMons: a systemaMc review and mulMlevel meta-analysis and meta-regression of mulMple outcomes.
Mindfulness, 10(6), 996-1005.
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CBT
• ݚڀͷ࣭͕͍ͱޮՌΛաਪఆ
1"%4"%Ͱݦஶʣ
0
0.2
0.4
0.6
0.8
1
PAD SAD GAD MDD
HQ
All
Cuijpers, P., Cristea, I. A., Karyotaki, E., Reijnders, M., & Huibers, M. J. (2016). How effecMve are cogniMve behavior
therapies for major depression and anxiety disorders? A meta-analyMc update of the evidence. World Psychiatry, 15(3),
245-258.
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CBT
• ෆ࣏҆ྍͷ
͏ͭප࣏ྍͰ͕౷
੍܈ʹػϦετ܈
• ػϦετ౷੍܈$#5ͷޮՌΛաେධՁ
Cuijpers, P., Cristea, I. A., Karyotaki, E., Reijnders, M., & Huibers, M. J. (2016). How effecMve are cogniMve behavior
therapies for major depression and anxiety disorders? A meta-analyMc update of the evidence. World Psychiatry,
15(3), 245-258.
0
0.5
1
1.5
PAD SAD GAD MDD
WL
TAU
Pill Placebo
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Guidi, J., Rafanelli, C., & Fava, G. A. (2018). The clinical role of well-being therapy. Nordic
journal of psychiatry, 72(6), 447-453.
• ޮՌͷաਪఆ
• ϊγʔϘ OPDFCP
ޮՌ
• ྙཧతʢ࣏ྍͷԆʣ
৺ཧྍ๏ͷ3$5ʹ͓͚Δదͳ౷੍܈ͱʁ
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: vs 16
:
Enck, P., & Zipfel, S. (2019). Placebo Effects in Psychotherapy: A Framework. FronMers in
Psychiatry, 10, 456.
Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Oce, C. (2017). Control condiMons for
randomised trials of behavioural intervenMons in psychiatry: a decision framework. The Lancet Psychiatry, 4(9), 725-732.
125 CBT RCT:
WL TAU, , pill-pracebo
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: vs 20
WLC TAU
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࣬ױ࣬ױͷಛੑݚڀϑΣʔζݚڀͷతೖ
खՄೳͳࢿݯͷτϨʔυΦϑͰ͖·Δɻ
Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Oce, C. (2017). Control condiMons for
randomised trials of behavioural intervenMons in psychiatry: a decision framework. The Lancet Psychiatry, 4(9), 725-732.
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Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Oce, C. (2017). Control condiMons for
randomised trials of behavioural intervenMons in psychiatry: a decision framework. The Lancet Psychiatry, 4(9), 725-732.
ױऀͷϦεΫ ࣬ױͷಛੑʣ
அͷҧ͍
ྟচతಛͷҧ͍
౷੍܈ͷ༧ظظ
ϊηϘͷੜ͢͡͞
ෳ༗ޮͳ࣏ྍ͕͋Δ߹ʹ
ະ࣏ྍ8-Λબ͢Δ߹ͷྙཧత
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Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Oce, C. (2017). Control condiMons for
randomised trials of behavioural intervenMons in psychiatry: a decision framework. The Lancet Psychiatry, 4(9), 725-732.
ྟচݚڀͷϑΣʔζ
1IBTF୳ࡧతͳ༰ྔ୳ࡧͳͲGFBTJCJMJUZ
1IBTF༧උతͳޮՌݚڀ લޙൺֱ
খن3$5
1IBTFݕূతͳޮՌݚڀ େن3$5
1IBTF༗ޮੑݚڀ ࣮ࢼݧʣ
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Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Oce, C. (2017). Control condiMons for
randomised trials of behavioural intervenMons in psychiatry: a decision framework. The Lancet Psychiatry, 4(9), 725-732.
ྟচݚڀͷϑΣʔζ
ॳظͷ୳ࡧతͳϑΣʔζ QIBTF
ͰɺݕূΛݫີʹ͢͠
͗ͣɺ༗ͳ࣏ྍΛૣ͍ͩΜ͔ΜͰݟམͱͯ͠͠·Θͳ͍Α
͏ʹ͢Δ 5ZQFΤϥʔͷճආʣɻ͜ͷஈ֊Ͱ8-͋Γɻ
ݕূతͳϑΣʔζͰɺΞΫςΟϒͳରর܈
৺ཧతϓϥη
Ϙ܈
σΟεϚϯτϦϯά౷੍܈ͳͲɺൺֱ͕ݫ֨ʢ৽ن࣏
ྍͷಛఆཁҼͷޮՌ͕໌֬ʹͳΔΑ͏౷੍܈Λઃఆʣ
࣮ࢼݧ F⒎FDUJWFOFTTTUVEZ
Ͱɺױऀબ࠷খ࣏ྍ
ͳͲ
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Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Oce, C. (2017). Control condiMons for
randomised trials of behavioural intervenMons in psychiatry: a decision framework. The Lancet Psychiatry, 4(9), 725-732.
ݚڀࢿݯ
ΞΫςΟϒͳ౷੍܈ίετ͕͔͔Δ
հೖऀͷޏ༻ͳͲ
খ͞ͳޮՌΛݕग़͢ΔͨΊʹɺେ͖ͳαϯ
ϓϧαΠζ͕ඞཁ
ˠαϯϓϧαΠζ࠶ਪఆదԠܕσβΠϯ༗ޮ
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Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Oce, C. (2017). Control condiMons for
randomised trials of behavioural intervenMons in psychiatry: a decision framework. The Lancet Psychiatry, 4(9), 725-732.
3$5ͷ࣮ࢪऀɺࢼݧͷϓϩτίϧจʹ
ࣄલʹ౷੍܈બͷਖ਼ੑʹ͍ͭͯৄࡉʹه
ࡌ͖͢
౷੍܈ΛબͿͱ͖ɺױऀूஂͱؔ࿈ϦεΫɺ
ݚڀͷϑΣʔζΛߟྀ
ϝλੳ࣏ྍΨΠυϥΠϯͰ౷੍܈ͷใ
Λ໌͖ࣔ͢
࣏ྍΨΠυϥΠϯʹɺػϦετ܈Ͱͷ3$5
Ͱ͔͠༗ޮੑ͕ࣔ͞Ε͍ͯͳ͍ͷܝࡌ͠
ͳ͍
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Take home message
• ਫ਼ਆྍ๏ͷ3$5·ͩ·ͩݕ౼ͷ༨͋Γ
• ·ͩ·࣭ͩͷߴ͍3$5ͷ࣮ࢪ͕ඞཁ
• ւ֎Ͱͦ͏͍ͬͨݱঢ়ͳͷͰ͍ΘΜࠃͰ
ʜ
• ਫ਼ਆྍ๏ͷ3$5Ͱ౷੍܈ͷઃఆ͕ॏཁ
• ױऀͷಛੑͱݚڀஈ֊ʹԠͯ͡ɺదͳ౷੍
܈ઃఆΛ
• ਫ਼ਆྍ๏ͷ3$5ͷΤϑΥʔτਙେͳͷͰɺ
ֶձओಋ·ͨνʔϜͰ
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No content
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(Research supported psychological intervenMon)
• ेʹཱ֬͞Ε࣏ͨྍ
• ͓ͦΒ͘ޮՌͷ͋Δ࣏ྍ
• ࣮ݧతͳ࣏ྍ
Chambless, D. L., & Hollon, S. D. (1998). Defining empirically supported therapies.
Journal of consulMng and clinical psychology, 66(1), 7.
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(research supported psychological intervenMon)
1 2
(
/
)
2
(
/ )
3
4
5
Chambless, D. L., & Hollon, S. D. (1998). Defining empirically supported therapies. Journal of consulMng and
clinical psychology, 66(1), 7.
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Gold, S. M., Enck, P., Hasselmann, H., Friede, T., Hegerl, U., Mohr, D. C., & Oce, C. (2017). Control condiMons for
randomised trials of behavioural intervenMons in psychiatry: a decision framework. The Lancet Psychiatry, 4(9), 725-732.
1IBTF୳ࡧతͳ༰ྔ୳ࡧͳͲGFBTJCJMJUZ
1IBTF༧උతͳޮՌݚڀ
લޙൺֱ
খن3$5
4$&%
1IBTFݕূతͳޮՌݚڀ
( RCT)
1IBTF༗ޮੑݚڀ ࣮ࢼݧ
4$&% ʣ
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1
1. ݸਓΛରʹ
2. ݸਓͰಠཱ
มΛૢ࡞
3. ΞτΞϜม
Λ෮ଌఆ
Kratochwill, T. R., Hitchcock, J., Horner, R. H., Levin, J. R., Odom, S. L., Rindskopf, D. M & Shadish, W. R. (2010). Single-case designs technical
documentaMon. Retrieved from What Works Clearinghouse website: hcp://ies.ed.gov/ncee/wwc/pdf/wwc_scd.pdf.
ϕʔεϥΠϯ
ظ
A
հೖظ
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1
1. ྟচ”࣮ફ”ͷޮՌΛՊֶతʹݕূՄೳ
• ΫϥΠΤϯτʹݱࡏ࣮ࢪ͍ͯ͠Δհೖ͕༗ޮ
͔ΛɺΫϥΠΤϯτͷ؍σʔλʹج͍ͮͯ
٬؍తʹஅͰ͖Δ
2. RCTͷ࣮ࢪ͕ࠔͳঢ়گͰհೖ๏ͷ༗ޮੑ
ΛՊֶతʹධՁ͢Δସ๏ͱͯ͠ͷظ
• ྫूੵͷݱ࣮తͳࠔ
• ౷੍܈ͷׂΓͯͷྙཧత
• RCTࣗମͷݶքͷࢦఠ
RCTͱ࣮ྟচͷױऀͱͷဃݸਓࠩ
Barlow, D. H., Nock, M., & Hersen, M. (2009). Single case experimental designs:
Strategies for studying behavior for change (No. Sirsi) i9780205474554).
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1
ࠃ·ֶͨձϨϕϧͰɺओཁͳλεΫϑΥʔε͕ɺ
RCTͱڞʹɺΤϏσϯεϕʔευͳհೖɾ࣏ྍͷޮՌ
ධՁʹ1ࣄྫ࣮ݧσβΠϯͷ׆༻Λਪ
• ถࠃ৺ཧֶձͷྟচɺࣇಐྟচ෦ձɺֶߍ৺ཧֶ෦ձ
ͷΤϏσϯεʹج͍ͮͨհೖͷλεΫϑΥʔε
• ถࠃࠃཱڭҭݚڀॴಡղҕһձ (National reading panel)
• ࠃཱڭҭධՁɾҬࢧԉηϯλʔͷWhat Works
ClearinghouseʹΑΔਪ
Kratochwill, T. R., & Levin, J. R. (2014). Single-case intervention research: Methodological and statistical
advances. American Psychological Association.
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1
ҩֶྖҬͰͷN of 1 trial (ABABσβΠϯ)ͷ
• Guyatte et al. (2000)͕JAMAץߦจͰ
ΤϏσϯε֊ͷτοϓ
• ΞϝϦΧҩֶձ(2000)ͰΤϏσϯε֊
ͷτοϓ
• Oxford center for Evidence
based medicineͷΤϏσϯεϨϕϧ(2011)
Ͱ”ڧݻͳΤϏσϯε”ʹ֘
Mirza, R. D., Punja, S., Vohra, S., & Guyac, G. (2017). The
history and development of N-of-1 trials. Journal of the
Royal Society of Medicine, 110(8), 330-340.
Guyac, G. H., Haynes, R. B., Jaeschke, R. Z., Cook, D. J., Green, L., Naylor, C. D., ... & Evidence-
Based Medicine Working Group. (2000). Users' guides to the medical literature: XXV. Evidence-
based medicine: principles for applying the users' guides to paMent care. Jama, 284(10),
1290-1296.
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Behavior Research and TherapyͰࠓͷ6݄߸ʹɺ
୯Ұࣄྫ࣮ݧσβΠϯͷಛू߸͕اը
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1
1. ܥ౷తͳಠཱมͷૢ࡞
2. ΞτΧϜมͷଌఆ
1ਓҎ্ͷධఆऀ
ධఆऀؒͷҰக͕Ұఆਫ४Ҏ্
(֤ϑΣʔζ20%Ҏ্ͷσʔλ༻)
3. গͳ͘ͱ֤ϑΣʔζ3࣌ͷଌఆɺ3ͭͷҟͳΔϑΣʔζ
Λ෮
4. ֤ϑΣʔζͰͷϨϕϧɺੑɺมಈੑͷ໌ࣔ
5. ޮՌͷ໌ࣔ
ޮՌͷimmediacy / ॏෳ / ϑΣʔζؒͰͷσʔλͷҰ؏ੑ
؍σʔλͱ༧ଌσʔλͷύλʔϯΛൺֱ
6. ֎తཁҼͱಛҟੑͷݕ౼
Institute of Education Sciences. (2014). What Works Clearinghouse procedures and standards handbook.
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1ࣄྫ࣮ݧݚڀͷใࠂͷ্࣭ͷͨΊͷΨΠυϥΠϯͷඋ
(SCRIBE໌)
ݚڀͷతଥੑͱ֎తଥੑΛۛຯ͢Δई (RoBiNT scale)
Tate, R. L., Perdices, M., Rosenkoecer, U., Wakim, D., Godbee, K., Togher, L., & McDonald, S. (2013). Revision of a method quality raMng
scale for single-case experimental designs and n-of-1 trials: The 15-item Risk of Bias in N-of-1 Trials (RoBiNT) Scale. Neuropsychological
rehabilitaMon, 23(5), 619-638.
Tate, R. L., Perdices, M., Rosenkoecer, U., McDonald, S., Togher, L., Shadish, W., ... & Sampson, M. (2016). The Single-Case ReporMng Guideline
In BEhavioural IntervenMons (SCRIBE) 2016: ExplanaMon and elaboraMon. Archives of ScienMfic Psychology, 4(1), 10.
• ॏෳܥɿ5BV6
– ϕʔεϥΠϯͷτϨϯυͷӨڹΛߟྀ
– ࣗݾ૬ؔߟྀ͞Εͳ͍
– ϊϯύϥϝτϦοΫͳࢦඪɺͷԾఆͳ͠
–
• ฏۉࠩ1)4ͷඪ४ԽޮՌྔ
ෳ໊ͷ࣌ܥྻσʔλΛ౷߹͠ޮՌྔΛࢉग़
ࣗݾ૬ؔτϨϯυΛߟྀ
ύϥϝτϦοΫͳࢦඪ
ਖ਼نҎ֎ͷʹ֦ுՄೳ
Parker, R. I., Vannest, K. J., Davis, J. L., & Sauber, S. B. (2011). Combining nonoverlap and trend for single-case research: Tau-
U. Behavior Therapy, 42(2), 284-299.
Pustejovsky, J. E., Hedges, L. V., & Shadish, W. R. (2014). Design-comparable effect sizes in mulMple baseline designs: A
general modeling framework. Journal of EducaMonal and Behavioral StaMsMcs, 39(5), 368-393.
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PHS
୯Ұࣄྫ࣮ݧͷ݁ՌΛɺଞͷ܈ؒൺֱσβΠ
ϯͷ݁ՌͷղऍͰ׳Ε͠ΜͰ͍ΔޮՌྔɺ
৴པ۠ؒʹج͍ͮͯղऍͰ͖Δɻ
ಉ͡ϦαʔνΫΤενϣϯΛ࣋ͭݸʑͷ୯Ұ
ࣄྫ࣮ݧͷ݁ՌΛ౷߹Ͱ͖Δɻ
ແ࡞ҝԽൺֱࢼݧͷΑ͏ͳ܈ؒൺֱࢼݧͷ݁
Ռͱ୯Ұࣄྫ࣮ݧͷ݁ՌΛൺֱͰ͖Δɻ
୯Ұࣄྫ࣮ݧͷ݁Ռͱଞͷ܈ؒൺֱσβΠϯ
ͷݟΛ౷߹Ͱ͖Δɻ
Shadish, W. R., Hedges, L. V., Horner, R. H., & Odom, S. L. (2015). The Role of Between-Case Effect Size in ConducMng,
InterpreMng, and Summarizing Single-Case Research. NCER 2015-002. NaMonal Center for EducaMon Research.
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δBC
=
√ +
1 3
(RCT DO) ( δBC
)
=
Shadish, W. R., Hedges, L. V., Horner, R. H., & Odom, S. L. (2015). The Role of Between-Case Effect Size in ConducMng,
InterpreMng, and Summarizing Single-Case Research. NCER 2015-002. NaMonal Center for EducaMon Research.
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CBT
:
ACT
:
Au, T. M., Sauer-Zavala, S., King, M. W., Petrocchi, N., Barlow, D. H., & Litz, B. T. (2017). Compassion-based therapy for trauma-related shame
and poscraumaMc stress: IniMal evaluaMon using a mulMple baseline design. Behavior therapy, 48(2), 207-221.
Ruiz, F. J., Flórez, C. L., García-Martín, M. B., Monroy-Cifuentes, A., Barreto-Montero, K., García-Beltrán, D. M., ... & Gil-Luciano, B. (2018).
A multiple-baseline evaluation of a brief acceptance and commitment therapy protocol focused on repetitive negative thinking for moderate
emotional disorders. Journal of Contextual Behavioral Science.
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CBT
Au, T. M., Sauer-Zavala, S., King, M. W., Petrocchi, N., Barlow, D. H., & Litz, B. T. (2017). Compassion-based therapy for trauma-
related shame and poscraumaMc stress: IniMal evaluaMon using a mulMple baseline design. Behavior therapy, 48(2), 207-221.
:
An overall, standardized mean difference effect size for each outcome
variable was also calculated, using a d-sta:s:c specifically developed for
singlecase designs (Shadish, Hedges, & Pustejovsky, 2014). The resulMng d-
staMsMc takes into account autocorrelaMon, between- and within-case
variance, and corrects for small sample bias using Hedges’ g. It is in the same
metric as the d-staMsMc used for between-subjects designs and can be
pooled with those staMsMcs in meta-analyses.
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CBT
Au, T. M., Sauer-Zavala, S., King, M. W., Petrocchi, N., Barlow, D. H., & Litz, B. T. (2017). Compassion-based therapy for trauma-
related shame and poscraumaMc stress: IniMal evaluaMon using a mulMple baseline design. Behavior therapy, 48(2), 207-221.
ACT
:
To obtain an overall esMmate of the effect size of the intervenMon, the design-comparable effect size for mulMple-baseline designs developed by Pustejovsky, Hedges,
and Shadish (2014) was computed. This standardized mean difference effect size for SCED shares the same metric as the Cohen's d typically used in group designs, which
facilitates the direct comparison and integraMon through meta-analysis of the results obtained in both types of designs. This d-staMsMc has a formal mathemaMcal development,
requires at least three cases for computaMon, and corrects for small sample bias using Hedges’ g. It is an extension of the standardized mean difference advocated by Hedges,
Pustejovsky, and Shadish (2012, 2013) that uses restricted maximum likelihood esMmaMon and offers the possibility of obtaining the d-staMsMc by controlling for baseline trend
and taking into account change in slope. The R package scdhlm was used to compute this d-staMsMc (Pustejovsky, 2016) following the guidelines provided by ValenMne, Tanner-
Smith, and Pustejovsky (2016). According to the global visual inspecMon of the dataset, we modelled baselines without trends including both fixed and random effects for level.
The treatment phase was modelled with linear trends with both fixed and random effects at level and slope. We computed the d-staMsMc to esMmate the overall effect sizes at
the 4-week follow-up (i.e., just before implemenMng the second session of the protocol) and at the 12-week follow-up.
RouMne outcome monitoring (ROM)
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Brattland, H., Koksvik, J. M., Burkeland, O., Gråwe, R. W., Klöckner, C., Linaker, O. M., ... & Iversen, V. C. (2018). The effects of
routine outcome monitoring (ROM) on therapy outcomes in the course of an implementation process: A randomized clinical
trial. Journal of counseling psychology, 65(5), 641.
Shimokawa, K., Lambert, M. J., & Smart, D. W. (2010). Enhancing treatment outcome of patients at risk of
treatment failure: meta-analytic and mega-analytic review of a psychotherapy quality assurance system. Journal
of consulting and clinical psychology, 78(3), 298.
Slide 51
Slide 51 text
RouMne outcome monitoring (ROM)
Van Der Lem, R., Van Der Wee, N. J., Van Veen, T., & Zitman, F. G. (2012). Efficacy versus effecMveness: a direct comparison
of the outcome of treatment for mild to moderate depression in randomized controlled trials and daily pracMce.
Psychotherapy and psychosomaMcs, 81(4), 226-234.
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Clinical pracMce < RCT (32 vs.40–74%).
Clinical pracMve < RCT (21 vs. 34–47%)
: Clinical pracice < RCT (27 vs. 34–58%
: Clinical pracMce < RCT (21 vs. 45–63%)