Top

BMC Psychiatry

Published in:

Open Access 01-12-2021 | Mood Disorders | Study protocol

Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial

Authors: Sigal Zilcha-Mano, Ben Shahar, Hadar Fisher, Tohar Dolev-Amit, Leslie S. Greenberg, Jacques P. Barber

Published in: BMC Psychiatry | Issue 1/2021

Abstract

Background

Major depressive disorder (MDD) is the leading cause of disability worldwide and one of the most heterogeneous mental health disorders. Although there are effective treatments for MDD, about 50% of patients do not respond to treatment. One of the greatest challenges in improving current treatments is identifying the mechanisms responsible for therapeutic change in MDD. The proposed study aims to identify patient-specific mechanisms of change in two treatments for MDD by investigating whether subpopulations of patients differ in the mechanisms of change that operate when receiving a given treatment. Based on theories of targeting weakness and building on strength, we will examine whether the mechanism of change operating when a treatment is provided depends on whether the treatment targets the patient’s strength or weakness.

Method

To test our hypothesis that two treatments, supportive-expressive treatment (SET) and emotion-focused treatment (EFT), differ in their mechanisms of change and to explore whether focusing on the patient’s strength or weakness will result in better treatment outcome, we conduct a mechanistic randomized controlled trial. One hundred and twenty-four individuals diagnosed with MDD are randomized to 16 sessions of either SET or EFT. The two treatments are theorized to differ in their main mechanism of change: SET places emphasis on insight as its main mechanism of change, and EFT places emphasis on emotional processing. Both can serve as strength- or weakness-focused treatments, based on the patient’s baseline levels of insight and emotional processing. The primary outcome is the Hamilton Rating Scale for Depression. Additional measures include self-report measures and clinical interviews, hormonal, motion, acoustic, physiological, and neuroimaging assessments, performance on cognitive tasks, and narrative material (collected from the sessions and interviews).

Discussion

The RCT will expand our understanding of mechanisms of change in psychotherapy, from one-size-fits-all to patient-specific mechanisms of change. By informing therapists about which of the two approaches is most effective with patients based on their baseline characteristics, the RCT will contribute to progress toward personalized treatment.

Trial registration

clinicaltrials.gov Identifier: NCT04576182 submitted on October 1st 2020. Funding: The Israel Science Foundation. Trial status: Recruitment is ongoing.

Friedrich MJ. Depression is the leading cause of disability around the world. JAMA. 2017;317:1517.PubMed

Crits-Christoph P, Gibbons MBC, Mukherjee D. Psychotherapy process outcome research. In: Oxford LMJ, editor. Bergin and Garfield’s handbook of psychotherapy and behavior change. 6th ed. England: Wiley; 2013. p. 298–340.

RJ DR, Strunk DR. The Oxford handbook of mood disorders. New York: Oxford University Press; 2017. https://doi.org/10.1093/oxfordhb/9780199973965.001.0001.CrossRef

Cuijpers P, Karyotaki E, Weitz E, Andersson G, Hollon SD, van Straten A. The effects of psychotherapies for major depression in adults on remission, recovery and improvement: a meta-analysis. J Affect Disord. 2014;159:118–26. https://doi.org/10.1016/j.jad.2014.02.026.CrossRefPubMed

DeRubeis RJ, Gelfand LA, German RE, Fournier JC, Forand NR. Understanding processes of change: how some patients reveal more than others—and some groups of therapists less—about what matters in psychotherapy. Psychother Res. 2014;24(3):419–28. https://doi.org/10.1080/10503307.2013.838654.CrossRefPubMed

DeRubeis RJ, Cohen ZD, Forand NR, Fournier JC, Gelfand LA, Lorenzo-Luaces L. The personalized advantage index: translating research on prediction into individualized treatment recommendations A demonstration. PloS One. 2014;9(1):e83875. https://doi.org/10.1371/journal.pone.0083875.CrossRefPubMedPubMedCentral

Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3(1):1–27. https://doi.org/10.1146/annurev.clinpsy.3.022806.091432.CrossRefPubMed

Crits-Christoph P, Connolly Gibbons MB. Psychotherapy process – outcome research. In: Barkham M, Lutz W, Castonguay L, editors. Handbook of psychotherapy and behavior change. 7th ed. New York: Wiley; 2021.

Barber JP, Muran JC, McCarthy KS, Keefe JR, Zilcha-Mano S. Research on dynamic therapies. In: Barkham M, Lutz W, Castonguay L, editors. Handbook of psychotherapy and behavior change. 7th ed. New York: Wiley; 2021.

10.

Jennissen S, Huber J, Ehrenthal JC, Schauenburg H, Dinger U. Association between insight and outcome of psychotherapy: systematic review and meta-analysis. Am J Psychiatry. 2018;175(10):961–9. https://doi.org/10.1176/appi.ajp.2018.17080847.CrossRefPubMed

11.

Peluso PR, Freund RR. Therapist and client emotional expression and psychotherapy outcomes: a meta-analysis. Psychother. 2018;55(4):461–72. https://doi.org/10.1037/pst0000165.CrossRef

12.

Aafjes van Doorn K, Barber JP. Systematic review of in-session affect experience in cognitive behavioral therapy for depression. Cognit Ther Res. 2017;41:807–28.CrossRef

13.

Connolly MB, Crits-Christoph P, Shelton RC, Hollon S, Kurtz J, Butler SF, et al. The reliability and validity of a measure of self-understanding of interpersonal patterns. J Couns Psychol. 1999;46(4):472–82. https://doi.org/10.1037/0022-0167.46.4.472.CrossRef

14.

Connolly Gibbons MB, Crits-Christoph P, Barber JP, Wiltsey Stirman S, Gallop R, Goldstein LA, et al. Unique and common mechanisms of change across cognitive and dynamic psychotherapies. J Consult Clin Psychol. 2009;77(5):801–13. https://doi.org/10.1037/a0016596.CrossRefPubMedCentral

15.

Høglend P. Insight into insight in psychotherapy. Am J Psychiatr. 2018;175(10):923–4. https://doi.org/10.1176/appi.ajp.2018.18050634.CrossRefPubMed

16.

Greenberg LS. Emotion-focused therapy: coaching clients to work through their feelings. 2nd ed. Washington: American Psychological Association; 2015. https://doi.org/10.1037/14692-000.CrossRef

17.

Pascual-Leone A. How clients “change emotion with emotion”: a programme of research on emotional processing. Psychother Res. 2018;28(2):165–82. https://doi.org/10.1080/10503307.2017.1349350.CrossRefPubMed

18.

Castonguay LG, Goldfried MR, Wiser S, Raue PJ, Hayes AM. Predicting the effect of cognitive therapy for depression: a study of unique and common factors. J Consult Clin Psychol. 1996;64(3):497–504. https://doi.org/10.1037/0022-006X.64.3.497.CrossRefPubMed

19.

Kivlighan DM, Marmarosh CL, Hilsenroth MJ. Client and therapist therapeutic alliance, session evaluation, and client reliable change: a moderated actor–partner interdependence model. J Couns Psychol. 2014;61(1):15–23. https://doi.org/10.1037/a0034939.CrossRefPubMed

20.

Lorenzo-Luaces L, German RE, DeRubeis RJ. It’s complicated: the relation between cognitive change procedures, cognitive change, and symptom change in cognitive therapy for depression. Clin Psychol Rev. 2015;41:3–15. https://doi.org/10.1016/j.cpr.2014.12.003.CrossRefPubMed

21.

Cohen ZD, DeRubeis RJ. Treatment selection in depression. Annu Rev Clin Psychol. 2018;14(1):209–36. https://doi.org/10.1146/annurev-clinpsy-050817-084746.CrossRefPubMed

22.

Barber JP, Muenz LR. The role of avoidance and obsessiveness in matching patients to cognitive and interpersonal psychotherapy: empirical findings from the treatment for depression collaborative research program. J Consult Clin Psychol. 1996;64(5):951–8. https://doi.org/10.1037/0022-006X.64.5.951.CrossRefPubMed

23.

Zilcha-Mano S. Major developments in methods addressing for whom psychotherapy may work and why. Psychother Res. 2019;29(6):693–708. https://doi.org/10.1080/10503307.2018.1429691.CrossRefPubMed

24.

Zilcha-Mano S. Toward personalized psychotherapy: the importance of the trait-like/state-like distinction for understanding therapeutic change. Am Psychol. 2020. https://doi.org/10.1037/amp0000629.

25.

Muller D, Judd CM, Yzerbyt VY. When moderation is mediated and mediation is moderated. J Pers Soc Psychol. 2005;89(6):852–63. https://doi.org/10.1037/0022-3514.89.6.852.CrossRefPubMed

26.

Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002;59(10):877–83. https://doi.org/10.1001/archpsyc.59.10.877.CrossRefPubMed

27.

Cheavens JS, Strunk DR, Lazarus SA, Goldstein LA. The compensation and capitalization models: a test of two approaches to individualizing the treatment of depression. Behav Res Ther. 2012;50(11):699–706. https://doi.org/10.1016/j.brat.2012.08.002.CrossRefPubMed

28.

Kiesler DJ. The 1982 interpersonal circle: a taxonomy for complementarity in human transactions. Psychol Rev. 1983;90(3):185–214. https://doi.org/10.1037/0033-295X.90.3.185.CrossRef

29.

Flückiger C, Grosse HM. Focusing the therapist’s attention on the patient’s strengths: a preliminary study to foster a mechanism of change in outpatient psychotherapy. J Clin Psychol. 2008;64(7):876–90. https://doi.org/10.1002/jclp.20493.CrossRefPubMed

30.

Luborsky L. Principles of psychoanalytic psychotherapy: a manual for supportive-expressive treatment. New York: Basic Books; 1984.

31.

Connolly Gibbons MB, Crits-Christoph P, Barber JP, Schamberger M. Insight in psychotherapy: a review of empirical literature. In: Castonguay LG, Hill C, editors. Insight in psychotherapy. Washington: American Psychological Association; 2007. p. 143–65. https://doi.org/10.1037/11532-007.CrossRef

32.

Greenberg LS. Emotion-focused therapy. Washington: American Psychological Association; 2011.

33.

Goldman RN, Greenberg LS, Pos AE. Depth of emotional experience and outcome. Psychother Res. 2005;15(3):248–60. https://doi.org/10.1080/10503300512331385188.CrossRefPubMed

34.

McAleavey AA, Castonguay LG. The process of change in psychotherapy: common and unique factors. In: Omar CGG, Alfred P, Bernd R, editors. Psychotherapy research. Vienna: Springer; 2015. p. 293–310.

35.

Bordin ES. The generalizability of the psychoanalytic concept of the working alliance. Psychol Psychother. 1979;16:252–60.

36.

Flückiger C, Del Re AC, Wampold BE, Horvath AO. The alliance in adult psychotherapy: a meta-analytic synthesis. Psychother. 2018;55(4):316–40. https://doi.org/10.1037/pst0000172.CrossRef

37.

Hatcher RL, Barends AW. How a return to theory could help alliance research. Psychother Theor Res Pract Train. 2006;43(3):292–9. https://doi.org/10.1037/0033-3204.43.3.292.CrossRef

38.

Lindquist R, Wyman JF, Talley KMC, Findorff MJ, Gross CR. Design of control-group conditions in clinical trials of behavioral interventions. J Nurs Scholarsh. 2007;39(3):214–21. https://doi.org/10.1111/j.1547-5069.2007.00171.x.CrossRefPubMed

39.

Chan A, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMedPubMedCentral

40.

Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59:22–33.PubMed

41.

Sheehan DV. Mini International Neuropsychiatric Interview English version 7.0.2 for DSM-5. University of South Florida College of Medicine; 2016.

42.

Hamilton MA. Development of a rating scale for primary depressive illness. Brit J Clin Psychol. 1967;6(4):278–96. https://doi.org/10.1111/j.2044-8260.1967.tb00530.x.CrossRef

43.

Rutherford BR, Taylor WD, Brown PJ, Sneed JR, Roose SP. Biological aging and the future of geriatric psychiatry. J Gerontol A Biol Sci Med Sci. 2016;72:343–52.CrossRef

44.

Luborsky L. Supportive-expressive dynamic psychotherapy of depression: a time-limited version. In: Barber JP, Crits-Christoph P, editors. Dynamic therapies for psychiatric disorders. New York: Basic Books; 1995. p. 41–83.

45.

Greenberg LS, Watson JC. Emotion-focused therapy for depression. Washington: American Psychological Association; 2006. https://doi.org/10.1037/11286-000.CrossRef

46.

Barber JP, Crits-Christoph P. Development of a therapist adherence/ competence rating scale for supportive-expressive dynamic psychotherapy: a preliminary report. Psychother Res. 1996;6(2):81–94. https://doi.org/10.1080/10503309612331331608.CrossRefPubMed

47.

Leibovich L, Zilcha-Mano S. What is the right time for supportive vs expressive interventions in supervision? An illustration based on a clinical mistake. Psychother. 2016;53(3):297–301. https://doi.org/10.1037/pst0000078.CrossRef

48.

Nof A, Leibovich L, Zilcha-Mano S. Supportive-expressive interventions in working through treatment termination. Psychother. 2017;54(1):29–36. https://doi.org/10.1037/pst0000094.CrossRef

49.

Freire E, Elliott R, Westwell G. Person-centred and experiential psychotherapy scale: development and reliability of an adherence/competence measure for person-centred and experiential psychotherapies. Couns Psychother Res. 2014;14(3):220–6. https://doi.org/10.1080/14733145.2013.808682.CrossRef

50.

Beck AT, Steer RA, Brown GK. Beck depression inventory-II. San Antonio. 1996;78:490–8.

51.

Pfohl B, Blum N, Zimmerman M. Structured interview for DSM-IV personality: SIDP-IV. Arlington: VA:American Psychiatric Pub; 1997.

52.

Moras, K. Early termination and the outcome of psychotherapy: Patients' perspectives. [Unpublished doctoral dissertation]. USA:Vanderbilt University; 1985.

53.

Beck AT, Steer RA. Manual for the Beck anxiety inventory. San Antonio: Psychological Corporation; 1990.

54.

Lambert MJ, Vermeersch DA, Brown GJ. Administration and scoring manual for the OQ-30.2. East Setauket: American Professional Credentialing Services; 2004.

55.

Barkham M, Hardy GE, Startup M. The IIP-32: a short version of the inventory of interpersonal problems. Br J Clin Psychol. 1996;35(1):21–35. https://doi.org/10.1111/j.2044-8260.1996.tb01159.x.CrossRefPubMed

56.

Endicott J, Nee J, Harrison W, Blumenthal R. Quality of life enjoyment and satisfaction questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321–6.PubMed

57.

Stanton AL, Kirk SB, Cameron CL, Danoff-Burg S. Coping through emotional approach: scale construction and validation. J Pers Soc Psychol. 2000;78(6):1150–69. https://doi.org/10.1037/0022-3514.78.6.1150.CrossRefPubMed

58.

Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003;85(2):348–62. https://doi.org/10.1037/0022-3514.85.2.348.CrossRefPubMed

59.

Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: development, factor structure, and initial validation of difficulties in emotion regulation scale. J Psychopathol Behav Assess. 2004;36:41–54.CrossRef

60.

Tracey TJ, Kokotovic AM. Factor structure of the working Alliance inventory. Psychol Assess. 1989;1(3):207–10. https://doi.org/10.1037/1040-3590.1.3.207.CrossRef

61.

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;5:1063–70.CrossRef

62.

McCarthy KS, Barber JP. The multitheoretical list of therapeutic interventions (MULTI): initial report. Psychother Res. 2009;19(1):96–113. https://doi.org/10.1080/10503300802524343.CrossRefPubMed

63.

Magnusson K. Technical appendix: details on the power calculations for two-and three-level models with missing data. 2018. Retrieved from https://cran.r-project.org/web/packages/powerlmm/vignettes/technical.pdf

64.

Driessen E, Hegelmaier LM, Abbass AA, Barber JP, Dekker JJ, Van HL, et al. The efficacy of short-term psychodynamic psychotherapy for depression: a meta-analysis update. Clin Psychol Rev. 2015;42:1–15. https://doi.org/10.1016/j.cpr.2015.07.004.CrossRefPubMed

65.

Ellison J, Greenberg L, Goldman R. Angus L. Maintenance of gains at follow-up in experiential therapies for depression. J Consult Clin Psychol 2009;77:103–112, 1, doi: https://doi.org/10.1037/a0014653.

Title: Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial
Authors: Sigal Zilcha-Mano
Ben Shahar
Hadar Fisher
Tohar Dolev-Amit
Leslie S. Greenberg
Jacques P. Barber
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Mood Disorders
Psychotherapy
Affective Disorder
Published in: BMC Psychiatry / Issue 1/2021
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-021-03279-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Investigating patient-specific mechanisms of change in SET vs. EFT for depression: study protocol for a mechanistic randomized controlled trial

Abstract

Background

Method

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Method

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2021

Psychological reactions and insomnia in adults with mental health disorders during the COVID-19 outbreak

Family alcohol use, rather than childhood trauma, is more likely to cause male alcohol use disorder: findings from a case-control study in northern China

Association study of a genetic variant in the long intergenic noncoding RNA (linc01080) with schizophrenia in Han Chinese

Predictive factors for the medical hospitalisation of patients who visited the emergency department with suicide attempt

Somatic health care professionals’ stigmatization of patients with mental disorder: a scoping review

Investigating the impact of COVID-19 lockdown on adults with a recent history of recurrent major depressive disorder: a multi-Centre study using remote measurement technology