CompletedNot Applicable

Halifax Somatic Symptoms Disorder Trial

Canada37 participantsStarted 2014-03

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Somatic Symptom Severity score using the SOMS-7 from baseline to week 8

Timeframe: Baseline, week 8

Trial details

NCT IDNCT02076867

SponsorNova Scotia Health Authority

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09

View on ClinicalTrials.gov More Somatic Symptom and Related Disorders trials