NCT01141426

Brief Summary

This study will use a randomized parallel group design to examine the effects of Intensive Short-term Dynamic Psychotherapy (ISTDP) for depressed patients non-remitting following at least one course of antidepressants. The effects of ISTDP will be judged through comparison against secondary care treatment as usual. The aim is to establish the clinical and cost effectiveness of ISTDP treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

5.1 years

First QC Date

June 9, 2010

Last Update Submit

August 12, 2022

Conditions

Depression

Keywords

depressiontreatment-resistancepsychodynamic psychotherapyTreatment refractory depression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression

    Baseline, 3, 6, 12, 18 months

Secondary Outcomes (10)

  • 7-item Generalized Anxiety Disorder Scale (GAD-7)

    Baseline, 3, 6, 9, 12, 18 months

  • Inventory of Interpersonal Problems 32-item

    Baseline, 3, 6, 9, 12, 18 months

  • Toronto Alexithymia Scale

    Baseline, 6, 9, 12, 18 months

  • 12-item Short-Form Health Survey (SF-12)

    Baseline, 3, 6, 12, 18 months

  • Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)

    Baseline, 3, 6, 9, 12, 18 months

  • +5 more secondary outcomes

Study Arms (2)

Secondary Care Treatment as Usual

ACTIVE COMPARATOR

At the four secondary health care sites, treatment as usual will consist of a multidisciplinary team approach including pharmacotherapy and clinical management, supportive or structured activities focused around symptom management and in some cases, individual or group psychotherapy. Pharmacotherapy treatment strategies will be individualized regimes informed by evidence-based recommendations. TAU will not be regulated in order to get a naturalistic assessment of standard secondary care treatment delivery with the exception that trial participants not be offered a psychodynamic / psychoanalytic based psychotherapy treatment during the course of the trial. Therapeutic interventions are likely to be heterogeneous therefore the trial coordinator will document in detail the dose and approaches delivered to each participant in order to account for this heterogeneity.

Behavioral: Secondary Care Treatment as Usual

Intensive Short-Term Dynamic Psychotherapy (ISTDP) Group

EXPERIMENTAL

The ISTDP model is an emotion focused brief format of psychotherapy that helps the patients identify and address emotional factors that culminate into exacerbation of depression and perpetuation of depression. The emphasis is on awareness of emotions and how they affect the person's behavioral patterns and mood. The research protocol calls for the treatment to be delivered according to a 20-session time-limited format. The first session is an extended 2-3 hour appointment (21), then sessions are planned to occur on a weekly basis lasting 60 minutes in duration. Termination in fewer sessions is based upon agreement between therapist and patient.

Behavioral: Intensive Short-term Dynamic Psychotherapy

Interventions

Intensive Short-term Dynamic PsychotherapyBEHAVIORAL

The ISTDP model is an emotion focused brief format of psychotherapy that helps the patients identify and address emotional factors that culminate into exacerbation of depression and perpetuation of depression. The emphasis is on awareness of emotions and how they affect the person's behavioral patterns and mood. The research protocol calls for the treatment to be delivered according to a 20-session time-limited format. The first session is an extended 2-3 hour appointment (21), then sessions are planned to occur on a weekly basis lasting 60 minutes in duration. Termination in fewer sessions is based upon agreement between therapist and patient.

Intensive Short-Term Dynamic Psychotherapy (ISTDP) Group
Secondary Care Treatment as UsualBEHAVIORAL

At the four secondary health care sites, treatment as usual will consist of a multidisciplinary team approach including pharmacotherapy and clinical management, supportive or structured activities focused around symptom management and in some cases, individual or group psychotherapy. Pharmacotherapy treatment strategies will be individualized regimes informed by evidence-based recommendations. TAU will not be regulated in order to get a naturalistic assessment of standard secondary care treatment delivery with the exception that trial participants not be offered a psychodynamic / psychoanalytic based psychotherapy treatment during the course of the trial. Therapeutic interventions are likely to be heterogeneous therefore the trial coordinator will document in detail the dose and approaches delivered to each participant in order to account for this heterogeneity.

Secondary Care Treatment as Usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 - 65 years.
  • Patients must identify depression as their primary problem (rather than being secondary to other mental health diagnosis).
  • Any DSM-IV diagnosis of Major Depression as assessed by the Mini Neuropsychiatric Interview plus (M.I.N.I. plus) at time of research intake interview.
  • Patients will have had at least one treatment trial of antidepressants at an acceptable therapeutic dose (length ≥ 6 weeks) for the current depressive episode without adequate response (score on the Hamilton Rating Scale for Depression ≥ 16 ) at time of screening interview.
  • Patients will not have started new medications in the previous ≥ 6 weeks, or have received psychotherapy treatment in the 12 months prior to being invited to participate in the study.
  • Participants will agree to video-taped sessions and will consent to the investigator accessing their information in clinical files and hospital database (e.g., medications, number of visits to health care professionals).

You may not qualify if:

  • Psychotic depression, bipolar depression, substance dependence, severe cluster A or B personality disorders, active suicidality, or cognitive impairment: such that patients require an intervention other than psychotherapy (as per the current protocol for the experimental treatment arm) or patients unable to give consent to treatment.
  • Patients with depression due to a general medical condition or secondary to a comorbid mental health or psychosocial condition will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Related Publications (20)

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    PMID: 14741909BACKGROUND

  • 2. Murray CJL, Lopez AD. The Global Burden of Disease. A Comprehensive Assessment of Mortality and Disability from Diseases, Injuries and Risk Factors in 1990 and Projected to 2020. Cambridge, Massachussetts: Harvard University Press; 1997.

    BACKGROUND

  • 3. McCrone P, Dhanasiri S, Patel A, Knapp M, Lawton-Smith S. Paying the Price: The Cost of Mental Health Care in England to 2026. London: King's Fund; 2008.

    BACKGROUND

  • Thomas CM, Morris S. Cost of depression among adults in England in 2000. Br J Psychiatry. 2003 Dec;183:514-9. doi: 10.1192/bjp.183.6.514.

    PMID: 14645022BACKGROUND

  • Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.

    PMID: 17074942BACKGROUND

  • Markowitz JC. When should psychotherapy be the treatment of choice for major depressive disorder? Curr Psychiatry Rep. 2008 Dec;10(6):452-7. doi: 10.1007/s11920-008-0073-7.

    PMID: 18980727BACKGROUND

  • Simon GE, Ludman E, Unutzer J, Bauer MS. Design and implementation of a randomized trial evaluating systematic care for bipolar disorder. Bipolar Disord. 2002 Aug;4(4):226-36. doi: 10.1034/j.1399-5618.2002.01190.x.

    PMID: 12190711BACKGROUND

  • Parikh SV, Segal ZV, Grigoriadis S, Ravindran AV, Kennedy SH, Lam RW, Patten SB; Canadian Network for Mood and Anxiety Treatments (CANMAT). Canadian Network for Mood and Anxiety Treatments (CANMAT) clinical guidelines for the management of major depressive disorder in adults. II. Psychotherapy alone or in combination with antidepressant medication. J Affect Disord. 2009 Oct;117 Suppl 1:S15-25. doi: 10.1016/j.jad.2009.06.042. Epub 2009 Aug 13.

    PMID: 19682749BACKGROUND

  • Stimpson N, Agrawal N, Lewis G. Randomised controlled trials investigating pharmacological and psychological interventions for treatment-refractory depression. Systematic review. Br J Psychiatry. 2002 Oct;181:284-94. doi: 10.1192/bjp.181.4.284.

    PMID: 12356654BACKGROUND

  • Trivedi RB, Nieuwsma JA, Williams JW Jr. Examination of the utility of psychotherapy for patients with treatment resistant depression: a systematic review. J Gen Intern Med. 2011 Jun;26(6):643-50. doi: 10.1007/s11606-010-1608-2. Epub 2010 Dec 24.

    PMID: 21184287BACKGROUND

  • 11. Luborsky L. Principles of psychoanalytic psychotherapy: A manual for supportive/expressive treatment New York: Basic Books; 1984.

    BACKGROUND

  • Driessen E, Cuijpers P, de Maat SC, Abbass AA, de Jonghe F, Dekker JJ. The efficacy of short-term psychodynamic psychotherapy for depression: a meta-analysis. Clin Psychol Rev. 2010 Feb;30(1):25-36. doi: 10.1016/j.cpr.2009.08.010.

    PMID: 19766369BACKGROUND

  • Barber JP, Crits-Christoph P, Luborsky L. Effects of therapist adherence and competence on patient outcome in brief dynamic therapy. J Consult Clin Psychol. 1996 Jun;64(3):619-22. doi: 10.1037//0022-006x.64.3.619.

    PMID: 8698958BACKGROUND

  • 14. Gaston L, Thompson L, Gallagher D, Cournoyer L-G, Gagnon R. Alliance, technique, and their interactions in predicting outcome of behavioral, cognitive, and brief dynamic therapy. Psychotherapy Research. 1998;8(2):190-209.

    BACKGROUND

  • Hilsenroth MJ, Ackerman SJ, Blagys MD, Baity MR, Mooney MA. Short-term psychodynamic psychotherapy for depression: an examination of statistical, clinically significant, and technique-specific change. J Nerv Ment Dis. 2003 Jun;191(6):349-57. doi: 10.1097/01.NMD.0000071582.11781.67.

    PMID: 12826915BACKGROUND

  • Abbass A, Sheldon A, Gyra J, Kalpin A. Intensive short-term dynamic psychotherapy for DSM-IV personality disorders: a randomized controlled trial. J Nerv Ment Dis. 2008 Mar;196(3):211-6. doi: 10.1097/NMD.0b013e3181662ff0.

    PMID: 18340256BACKGROUND

  • Abbass A, Kisely S, Kroenke K. Short-term psychodynamic psychotherapy for somatic disorders. Systematic review and meta-analysis of clinical trials. Psychother Psychosom. 2009;78(5):265-74. doi: 10.1159/000228247. Epub 2009 Jul 11.

    PMID: 19602915BACKGROUND

  • Abbass A, Town J, Driessen E. Intensive short-term dynamic psychotherapy: a systematic review and meta-analysis of outcome research. Harv Rev Psychiatry. 2012 Mar-Apr;20(2):97-108. doi: 10.3109/10673229.2012.677347.

    PMID: 22512743BACKGROUND

  • Abbass AA. Intensive Short-Term Dynamic Psychotherapy of treatment-resistant depression: a pilot study. Depress Anxiety. 2006;23(7):449-52. doi: 10.1002/da.20203.

    PMID: 16845654BACKGROUND

  • Town JM, Falkenstrom F, Abbass A, Stride C. The anger-depression mechanism in dynamic therapy: Experiencing previously avoided anger positively predicts reduction in depression via working alliance and insight. J Couns Psychol. 2022 Apr;69(3):326-336. doi: 10.1037/cou0000581. Epub 2021 Sep 30.

    PMID: 34591500DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Joel Town

    Capital District Health Authority and Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Joel Town

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 10, 2010

Study Start

September 1, 2012

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations

CA(1)