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Halifax Somatic Symptoms Disorder Trial

NCT02076867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-04-08

No results posted yet for this study

Summary

The purpose of this pilot study is to compare the effectiveness of Intensive Short-Term Dynamic Psychotherapy (ISTDP) plus Medical Care As Usual (MCAU) compared to MCAU for Somatic Symptom and Related Disorders (SSRD). Consenting patients presenting to the emergency department with suspected SSRD will be randomly allocated to receive either 8 weekly individual sessions of ISTDP or to an 8-week wait list followed by ISTDP. MCAU including emergency department and/or family doctor consultation is available throughout trial participation. The primary outcome measure is participant self-reported somatic symptoms at week 8.

Conditions

  • Somatic Symptom and Related Disorders
  • Intensive Short Term Dynamic Psychotherapy

Interventions

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 and perpetuation of somatic symptoms. Treatment will be provided according to manualized recommendations. The emphasis is on awareness of emotions and how they affect the person's behavioral patterns and somatic presentation. The research protocol calls for the treatment duration to be initially agreed at 8 weeks and then reviewed. Treatment should be delivered as a maximum 20-session time-limited format. The first session is an extended 2-3 hour appointment; then sessions are planned to occur on a weekly basis lasting 60 minutes in duration. Treatment progress is reviewed, specifically at sessions 4 and 8 to clarify the goal and objectives of further sessions. Patients are informed of the maximum treatment length. Termination in fewer sessions is based upon agreement between therapist and patient.

BEHAVIORAL

Medical Care As Usual (MCAU)

This Medical Care As Usual (MCAU) was selected to control for both the role of emergency department care and family doctors care, as well as the passage of time and the natural emergence and reduction in symptoms before further intervention. Participants allocated to this group are advised that care will continue to be provided to them by the ED and they will be contacted with an appointment to see a therapist in 8 weeks should they so wish. They are advised to contact their family physician for routine care where necessary

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Joel M Town, DClinPsy · Capital District Health Authority and Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02076867 on ClinicalTrials.gov