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Halifax Somatic Symptoms Disorder Trial

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ClinicalTrials.gov Identifier: NCT02076867
Recruitment Status : Unknown
Verified February 2014 by Joel Town, Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
First Posted : March 4, 2014
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
Joel Town, Nova Scotia Health Authority

Brief Summary:
The purpose of this 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.

Condition or disease Intervention/treatment Phase
Somatic Symptom and Related Disorders Intensive Short Term Dynamic Psychotherapy Behavioral: Intensive Short-Term Dynamic Psychotherapy Behavioral: Medical Care As Usual (MCAU) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Halifax Somatic Symptom Disorder Trial: A Randomized Parallel Group Cross-Over Study of Intensive Short-Term Dynamic Psychotherapy Compared to Medical Treatment as Usual for Somatic Symptoms in the Emergency Department
Study Start Date : March 2014
Estimated Primary Completion Date : February 2016

Arm Intervention/treatment
Experimental: Intensive Short Term Dynamic Psychotherapy (ISTDP) 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.

Active Comparator: Medical Care As Usual (MCAU) 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




Primary Outcome Measures :
  1. Change in Somatic Symptom Severity score using the SOMS-7 from baseline to week 8 [ Time Frame: Baseline, week 8 ]
    Symptom score at week 8 in the MCAU group will be compared to the ISTDP group at week 8. Sub-analyses will examine the MCAU score at week 8 versus the ISTDP score at the last session in cases where treatment is extended beyond week 8 treatment to a maximum of 20 sessions.


Secondary Outcome Measures :
  1. Change in depression score using the Patient Health Questionnaire-depression scale (PHQ-9) from baseline to 8 weeks [ Time Frame: Baseline, week 8 ]
    Sub-analyses will examine the MCAU score at week 8 versus the ISTDP score at the last session in cases where treatment is extended beyond week 8 treatment to a maximum of 20 sessions.

  2. Change on Whiteley Index for Health Anxiety from baseline to week 8 [ Time Frame: Baseline, week 8 ]
    Sub-analyses will examine the MCAU score at week 8 versus the ISTDP score at the last session in cases where treatment is extended beyond week 8 treatment to a maximum of 20 sessions.

  3. Change on Short Form Health Survey (SF-12) from baseline to week 8 [ Time Frame: Baseline, week 8 ]
    Sub-analyses will examine the MCAU score at week 8 versus the ISTDP score at the last session in cases where treatment is extended beyond week 8 treatment to a maximum of 20 sessions.

  4. Change on Inventory of Interpersonal Problems (IIP-32) from baseline to week 8 [ Time Frame: Baseline, week 8 ]
    Sub-analyses will examine the MCAU score at week 8 versus the ISTDP score at the last session in cases where treatment is extended beyond week 8 treatment to a maximum of 20 sessions.

  5. Presence of somatic symptom and related disorder diagnosis using the Structured Clinical Interview for DSM Disorders Version 5- Research Version at week 8 [ Time Frame: week 8 ]
    Sub-analyses will examine the MCAU score at week 8 versus the ISTDP score at the last session in cases where treatment is extended beyond week 8 treatment to a maximum of 20 sessions.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18-65 years
  • Emergency department physician determines that physical symptoms and/ or impairment associated with the physical symptoms are not explained by physical pathology.
  • Patients must meet diagnostic criteria for a Somatic Symptom or Related Disorder (SSRD) as assessed by the Structured Clinical Interview for DSM Disorders 5th Edition Research Version (SCID-5-RV).
  • Symptom duration of at least 3 months or recurrently each month.
  • Cut off of at least 4 symptoms for men and 6 for women using the SOMS.
  • Participants consent to audio-visual taped sessions and the investigator accessing their electronic health records, if deemed necessary.
  • Stable with pharmacotherapy over previous 4 weeks.

Exclusion Criteria:

  • Symptoms which can be entirely explained by a medical condition.
  • Already receiving ongoing psychological treatment.
  • The research physician determines that the physical symptoms and/ or impairment has definite physical pathology.
  • Any diagnosis of current psychosis, bipolar or manic depression, substance abuse/dependence or active suicidality as assessed by the SCID-5-RV.
  • Complaints which are considered to be malingering or factitious.
  • Patients who are unable to give informed consent to treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076867


Contacts
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Contact: Joel M Town, DClinPsy 6024732543 joel.town@dal.ca

Locations
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Canada, Nova Scotia
Capital District Health Authority Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2E2
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Joel M Town, DClinPsy Capital District Health Authority and Dalhousie University

Additional Information:
Publications:
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Responsible Party: Joel Town, Clinical Psychologist & Assistant Professor, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02076867     History of Changes
Other Study ID Numbers: CDHA-RS/2014-274
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: February 2014
Keywords provided by Joel Town, Nova Scotia Health Authority:
somatic symptoms and related disorders
somatic symptoms
psychodynamic psychotherapy
Additional relevant MeSH terms:
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Disease
Medically Unexplained Symptoms
Pathologic Processes
Signs and Symptoms