Halifax Somatic Symptoms Disorder Trial

NCT02076867 | Completed

• 1 other identifier: CDHA-RS/2014-274
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

somatic symptoms and related disorders; somatic symptoms; psychodynamic psychotherapy

Outcome Measures

Primary Outcomes (1)

• Change in Somatic Symptom Severity score using the SOMS-7 from baseline to 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.

  Baseline, week 8

Secondary Outcomes (4)

• Change in depression score using the Patient Health Questionnaire-depression scale (PHQ-9) from baseline to 8 weeks

  Baseline, week 8

• Change on Whiteley Index for Health Anxiety from baseline to week 8

  Baseline, week 8

• Change on Inventory of Interpersonal Problems (IIP-32) from baseline to week 8

  Baseline, week 8

• Presence of somatic symptom and related disorder diagnosis using the Structured Clinical Interview for DSM Disorders Version 5- Research Version at week 8

  week 8

Study Arms (2)

Intensive Short Term Dynamic Psychotherapy (ISTDP)

EXPERIMENTAL

Behavioral: Intensive Short-Term Dynamic Psychotherapy

Medical Care As Usual (MCAU)

ACTIVE COMPARATOR

Behavioral: Intensive Short-Term Dynamic Psychotherapy; Behavioral: Medical Care As Usual (MCAU)

Interventions

Intensive Short-Term Dynamic Psychotherapy BEHAVIORAL

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.

Intensive Short Term Dynamic Psychotherapy (ISTDP); Medical Care As Usual (MCAU)

Medical Care As Usual (MCAU) BEHAVIORAL

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

Medical Care As Usual (MCAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Capital District Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Related Publications (2)

• Kroenke K. Patients presenting with somatic complaints: epidemiology, psychiatric comorbidity and management. Int J Methods Psychiatr Res. 2003;12(1):34-43. doi: 10.1002/mpr.140.

  PMID: 12830308 BACKGROUND

• Town JM, Abbass A, Campbell S. Halifax somatic symptom disorder trial: A pilot randomized controlled trial of intensive short-term dynamic psychotherapy in the emergency department. J Psychosom Res. 2024 Dec;187:111889. doi: 10.1016/j.jpsychores.2024.111889. Epub 2024 Aug 22.

  PMID: 39241562 DERIVED

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel M Town, DClinPsy

  Capital District Health Authority and Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist & Assistant Professor

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

CA (1)