Halifax Somatic Symptoms Disorder Trial
Halifax Somatic Symptoms Disorder Trial
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.
The purpose of our study Given the significant illness burden associated to somatic symptom
 and related disorders, and given the marked reduction in ED visits and severity of symptoms
 following this form of short-term treatment, there is an urgent need to directly examine
 those patients who do not attend initial consultation or fail to complete treatment. This
 population is complex and is considered at high risk. Currently, insufficient information is
 known about the specific baseline characteristics, and the short- and long-term outcomes for
 these two sub-samples of patients not initiating or not completing treatment.

 Objectives

 -  First, we will examine the outcomes of patients receiving Medical Care As Usual (MCAU)
 followed by an 8-week wait-list for ISTDP versus MCAU plus ISTDP without wait in order
 to establish the efficacy of this treatment for somatic symptom disorders.

 -  Second, we will identify specific patient variables that predict outcomes in order to
 identify the characteristics of patients with less optimal outcomes and treatment
 failures.

 -  Third, we will conduct a preliminary examination of processes underlying symptom change
 in ISTDP.

 -  Finally, an optional sub-study will explore patients' experiences of the service
 provided at the MUS clinic, in order to uncover the specific variables that are
 associated with clinical benefits.

 Specific goal Through this project, therefore, we will generate new knowledge directly
 translatable to the goal of improving outcomes for a greater percentage of referred patients.
 This population is complex and is considered at high risk. There is a pressing need to reach
 out to a greater number of patients with SSRD, in order to alleviate suffering and reduce the
 costs associated to repeated health care use.

 METHOD

 Design Using a randomized control trial design this study will examine the efficacy of ISTDP
 for patients with Somatic Symptom and Related Disorders (SSRD). Participants are randomly
 allocated to either MCAU plus ISTDP or MCAU. The primary outcome measure is somatic symptoms
 severity score (SOMS-7 SS)5 at T1 (8 weeks). After 8-weeks in the MCAU condition participants
 will then crossover to ISTDP if necessary.

 Setting and study sample Eligible participants will be new referrals to the Capital District
 Health Authority Medically Unexplained Symptoms clinic by an emergency department physician
 for assessment and possible treatment for unexplained somatic symptoms. Referrals will be
 accepted from physicians at two local emergency wards (Halifax and Dartmouth). Participants
 will be adult outpatients, aged 18-65 years, meeting the study inclusion and exclusion
 criteria.

 Psychiatric Diagnoses Psychiatric diagnoses will be established using the SCID 5-RV13
 administered by a trained research assistant. The assessment will include administration of
 the SCID 5-RV overview to evaluate medical, psychiatric and personal history, and also
 information on demographic factors (age, gender, marital status, education, professional
 occupation).

 Co-occurring therapies At each time point participant will be asked to self-report their use
 of concurrent treatment, intervention or other management strategies e.g., pain medication,
 psychiatric medication (antidepressant medication), consultation with family physician,
 specialist clinic appointments.

 Change processes measures Trained researchers will review videotaped recordings of ISTDP and
 rate therapist and patient behavior including the following scales: (a) Achievement of
 Therapeutic Objective Scale (ATOS), a measure of the degree to which patients achieve
 in-session treatment objectives (e.g., Affective Experiencing); (b) Comparative Psychotherapy
 Process Checklist (CPPS), includes two scales for rating how characteristic the therapists'
 interventions are of Psychodynamic-Interpersonal versus Cognitive-Behavioural treatments; (c)
 ISTDP Process Scale, a measure for assessing the degree of mobilization of unconscious
 processes, consistent with ISTDP theory.

 Statistical Power In order to detect an average between-group effect size of d = .70, a
 significance level of alpha = .05 and two groups of participants, a total sample of 68
 participants is required to achieve 80% power. Assuming a loss to follow-up rate of 15%, we
 expect we will need to recruit 78 participants to achieve this goal.

 Analysis The primary analysis population is the intention-to-treat (ITT) sample. Secondary
 analysis will be calculated in an observed-cases sample, which will consist of all patients
 where complete observed data is available. Sub-analyses will examine three definitions of
 ISTDP treatment: Completed when 20 sessions have been delivered or the termination of
 treatment occurs by mutual consensus based on symptom remission and/or agreement that an
 adequate treatment dose has been delivered; Partial Treatment when 2 or more sessions are
 attended; Trial only attended. For these analyses, missing data will be replaced through a
 multiple imputation approach where possible.

 Initially group differences will be examined using analyses of covariance (ANCOVA) to assess
 efficacy (SOMS-SSI) at 8-week post allocation. Clinically significant change in somatic
 symptoms will be examined by first calculating the Reliable Change Index (RCI) to assess
 psychometrically reliable change at the patient level. Next, the post treatment test scores
 are examined to determine whether they fall below the clinical cut-off, within 2 SD of the
 normative mean. Patients who meet both criteria are considered to have achieved clinically
 significant change. Finally, overall effectiveness of ISTDP will be examined using the whole
 treated sample at two time points; the final treatment session and 6-month post treatment.
 Separate analyses will include number of treatment sessions as a covariate of outcome.

 Process analyses A series of regression analyses will be conducted to examine if changes in
 putative moderator and mediator variables predict between group (ISTDP v. MCAU) treatment
 efficacy (SOMS-SSI). Hypothesized processes of change in somatic symptom severity across
 ISTDP sessions will be examined using parallel process latent growth curve models.
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.