Halifax Somatic Symptoms Disorder Trial
Condition: Somatic Symptom and Related Disorders; Intensive Short Term Dynamic Psychotherapy
MeSH terms: Medically Unexplained Symptoms
Study type: Interventional

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.
    

Detailed description: 
      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.

      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 The required sample size for this pilot study was set at 40 in order to
      provide sufficient data to conduct preliminary analyses of the stated study objectives.

      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.
    

Intervention name(s): Intensive Short-Term Dynamic Psychotherapy; Medical Care As Usual (MCAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: somatic symptoms and related disorders; somatic symptoms; psychodynamic psychotherapy