Halifax Treatment Refractory Depression Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Joel Town, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01141426
First received: June 9, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Depression
Behavioral: Intensive Short-term Dynamic Psychotherapy
Behavioral: Secondary Care Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Halifax Treatment Refractory Depression Trial: A Randomized Controlled Trial of Intensive Short-Term Dynamic Psychotherapy (ISTDP) Compared to Secondary Care Treatment as Usual

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: Baseline, 3, 6, 12, 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-item Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: Baseline, 3, 6, 9, 12, 18 months ] [ Designated as safety issue: No ]
  • Inventory of Interpersonal Problems 32-item [ Time Frame: Baseline, 3, 6, 9, 12, 18 months ] [ Designated as safety issue: No ]
  • Toronto Alexithymia Scale [ Time Frame: Baseline, 6, 9, 12, 18 months ] [ Designated as safety issue: No ]
  • 12-item Short-Form Health Survey (SF-12) [ Time Frame: Baseline, 3, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) [ Time Frame: Baseline, 3, 6, 9, 12, 18 months ] [ Designated as safety issue: No ]
  • Trimbos and Institute of medical technology Assessment Cost Questionnaire for Psychiatry [ Time Frame: Baseline, 6, 12, 18 months ] [ Designated as safety issue: No ]
  • 9-item Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 3, 6, 9, 12, 18 months ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire-somatic symptom scale (PHQ-12) [ Time Frame: Baseline, 3, 6, 9, 12, 18-month ] [ Designated as safety issue: No ]
  • Mini International Neuropsychiatric Inventory plus (M.I.N.I. plus) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
  • Computerized Assessment SCID for DSM-IV (CAS-II) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: September 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Secondary Care Treatment as Usual
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
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.
Experimental: Intensive Short-Term Dynamic Psychotherapy (ISTDP) Group
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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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).

Exclusion criteria

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141426

Contacts
Contact: Joel M Town, DClinPsy 9024732543 joel.town@dal.ca

Locations
Canada, Nova Scotia
Capital District Health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Contact: Joel M Town    902-473-2543    joel.town@dal.ca   
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Joel Town Capital District Health Authority and Dalhousie University
  More Information

Additional Information:
Publications:
1. WHO. The World Health Report 2002: Reducing Risks, Promoting Healthy Life. Geneva, Switzerland: WHO2002.
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.
10. Trivedi RB, Nieuwsma JA, Williams JW, Jr. Examination of the utility of psychotherapy for patients with treatment resistant depression: a systematic review. Journal of general internal medicine. 2011;26(6):643-50. Epub 2010/12/25.
11. Luborsky L. Principles of psychoanalytic psychotherapy: A manual for supportive/expressive treatment New York: Basic Books; 1984.

Responsible Party: Joel Town, Dr. Joel Town, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01141426     History of Changes
Other Study ID Numbers: AA002
Study First Received: June 9, 2010
Last Updated: February 22, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
depression
treatment-resistance
psychodynamic psychotherapy
Treatment refractory depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 16, 2014