The Roles of the Therapeutic Alliance in Understanding the Effects of Attachment Orientations on Outcome in Psychotherapy
Phase: NA
Conditions: Major Depressive Disorder
Sponsor: University of Haifa

  
  
  
  
The Roles of the Therapeutic Alliance in 
Understanding the Effects of Attachment 
Orientations on Outcome in 
Psychotherapy 
  
  
  
  
NCT Number: NCT02728557  
Date of Submission: 21.01.2016  
Principal Investigator: Dr. Sigal Zilcha-Mano  
Affiliation: University of Haifa  
Funding Source: Israeli Science Foundation (Grant 186/15)  
  
 
 
 
 
 
 
 
 
 
 

Study design  
The study is designed to reach an assignment ratio of 1:1 for supportive-expressive vs. 
supportive treatment. Assignment to treatment arm is conducted by an outside institution, 
not involved in the study, the Biostatistics Department of the Gertner Institute for 
Epidemiology and Health Policy Research. Assignment to treatment arm is based on the 
minimization algorithm). Factors for balancing are age (higher or equal vs. lower than 30), 
gender (male vs. female), family status (married/cohabiting vs. not married/cohabiting), 
baseline 17-item Hamilton Rating Scale, HRSD (higher or equal vs. lower than 20), baseline 
attachment avoidance (higher or equal vs. lower than 3.5 on the Experience in Close 
Relationships, ECR; see details in the Measures section), baseline attachment anxiety (higher 
or equal vs. lower than 3.5 on the ECR), and personality disorders (present vs. absent). 
Except for the therapist, the entire research team is blind to the patients’ assignment to 
treatment.  
Participants  
One hundred patients with MDD are being recruited through advertisements in the central 
regions of Israel, offering free treatment at the psychotherapy research lab clinic.  
Inclusion criteria  
(a) MDD diagnostic criteria using the structured clinical interviews for DSM-V, with scores 
above 14 on the 17-item HRSD at two evaluations, one week apart, and current MDD based 
on the MINI (International Neuropsychiatric Interview;) (b) if on medication, patients’ 
dosage must be stable for at least three months before the start of the study, and they must 
be willing to maintain stable dosage for the duration of treatment; (c) age between 18 and 
60 years; (d) Hebrew language fluency; (e) provision of written informed consent.  
Exclusion criteria  
(a) current risk of suicide or self-harm (HRSD suicide item > 2); (b) current substance abuse 
disorder; (c) current or past schizophrenia or psychosis, bipolar disorder, or severe eating 
disorder, requiring medical monitoring; (d) history of organic mental disease; (e) currently in 
psychotherapy.  
Treatments  
Patients will receive 16 50-min sessions of SE treatment (SE), a time-limited psychodynamic 
therapy adapted for depression, either in an expressive-focused condition (including the use 
of expressive techniques, such as interpretation, confrontation, clarification), or in a 
supportive-focused condition (including the use of supportive techniques, such as 
affirmation and empathic validation). We use comprehensive treatment protocols. For SE 
treatment, we use the Luborsky manualized treatment. The supportive condition includes all 
supportive techniques detailed in the manual used by Luborsky, but forbids the use of any 
expressive techniques, as detailed in. After the end of treatment, once a month, a 
maintenance session will be provided to all patients with their treating therapists, for a total 
of 4 follow-up sessions.  
  
 

Therapists  
Therapists will act as their own controls to avoid nesting of therapists within treatment 
conditions, which may result in unwanted confounding. This approach has been found to be 
feasible in previous trials. To control for therapist allegiance, all therapists will be asked to 
report their preferences before the start of treatment, and we will control for these 
preferences in the analyses.  
Therapists interested in participating in the RCT answered ads seeking psychologists with at 
least five years of expertise in psychodynamic treatment, willing to participate in an RCT on 
short-term psychodynamic treatment. After interviews, eight therapists were accepted into 
the study. All had formal training and experience in psychodynamic treatment. The 
therapists attended a 20-h training workshop in supportive and expressive techniques. The 
training included formal teaching and role playing, using the different techniques. Two of the 
therapists did not continue after the training phase for various reasons (one being offered a 
full-time position elsewhere, the other demonstrating low levels of adherence).  
All therapists completed treatment of two pilot patients, one of each treatment type, and 
had to demonstrate sufficient adherence before moving into the trial phase. During the pilot 
phase, and after the start of the research, each therapist received weekly group supervision 
from two supervisors, as well as weekly individual supervision from one of the supervisors. 
Individual and group supervisions make extensive use of videotaped sessions for feedback.  
The supervisors are licensed clinical psychologists, with extensive supervision experience. 
The supervisors receive supervision concerning the supervision process from an 
international expert in SE, with more than 20 years of experience in psychodynamic 
treatment for depression, and more than 15 years of experience in SE treatments in RCTs.  
Fidelity check  
We use the Penn Adherence-Competence Scale (PACS) to examine the degree to which 
therapists adhere to the manual in the techniques they are using, whether they are 
competent in the use of the technique, and whether they avoid the use of techniques that 
are forbidden (based on the condition to which their patient was assigned). The PACS 
includes 3 subscales: general therapeutic behaviors, the supportive component, and the 
expressive component. The two conditions of the present study are expected to differ on 
the expressive component. The research team is supervised by an international expert on 
the use of the PACS, with vast experience in using the PACS in RCTs on SE treatment. In 
instances of low adherence or competence, relevant supervision tools will be deployed. As 
detailed above, therapists attend weekly individual and group supervisions for the entire 
duration of their participation in the study. In the supervision session, videotaped sessions 
are being analyzed, looking for instances of deviations from the manual to be worked 
through.  
Procedure and randomization  
Applicants are recruited by self-referral, based on advertisements. Recruitment information 
is disseminated by posters, local media, and online publications (social media, etc.). 
Application is by email or phone. In an initial phone screening, the interested individuals are 
informed about the study procedure and the relevant inclusion and exclusion criteria. If 
there are indications of depressive complaints, applicants who consent to the research 
intake procedure are asked to complete the BDI-II (Beck Depression Inventory). To ensure 

high levels of severity of depressive symptoms, applicants must score at least 19 points on 
the BDI-II. Applicants who scored 19 points and above on the BDI-II are contacted to 
schedule an initial intake meeting during which researchers explain the study, and there is 
opportunity to discuss any questions. Applicants receive written and oral information about 
the content and extent of the planned study. This includes information about the treatment, 
including safety and possible risks, the information that all treatment sessions are 
videotaped, and about their right to withdraw from the research at any time. Applicants who 
agree to participate are required to sign the informed consent form. At the first face-to-face 
assessment, the HRSD interview is administered, and participants receive a baseline battery 
of questionnaires, including demographic information, concurrent medication, and 
measures of personality characteristics and comorbid conditions. At the second interview, 
the HRSD and the MINI are administered to measure the presence and severity of baseline 
symptom and comorbid conditions, and participants provide saliva samples.  
The first and the second interviews of all participants, as well as all the assessments before 
and after each session, are administered by the same evaluator who has been extensively 
trained and was found to be reliable in the use of the HRSD and the MINI. The evaluators are 
trained in the administration of both measures. After successfully completing two months of 
extensive training and achieving high reliability, evaluators begin by observing another 
evaluator at work, after which they administer the measures with a trained evaluator for 
several weeks, before performing the evaluation by themselves. Throughout the trial period, 
the reliability of the evaluators is evaluated on a weekly basis.  
  
After the second interview, a third face-to-face meeting is scheduled, at which the 
Structured Interview for DSM-IV Personality, SIDP [50] is administered by a different trained 
and reliable evaluator, to assess comorbid personality disorders. The evaluators are trained 
in the administration of the measure. After successfully completing extensive training and 
achieving high reliability, evaluators begin by observing another evaluator at work. Next, 
they administer the measures together with a trained evaluator for several weeks, before 
performing the evaluation by themselves. Throughout the trial period, the reliability of the 
evaluators is assessed every week. If eligible for the study, participants receive further 
written and oral information about the treatments and about the full research procedure 
and assessments, before being randomized to one of the treatment conditions. They also 
indicate whether they can be contacted again after the study for additional waves and for 
extending the follow-up period beyond the specified two years.  
  
Applicants who are not eligible for the study (having not met the inclusion criteria or having 
met an exclusion criterion), yet request psychotherapy, are referred to appropriate care. 
Participants meeting inclusion criteria are randomized to one of the two treatment arms. 
Researchers, assessors, intakers, and the entire research team remain blind to treatment 
allocation. The only team members who are exposed to treatment assignment are, by 
necessity, the therapists and clinical supervisors. The following strategies are used to 
minimize bias that could arise from revealing treatment allocation: (a) all patients are blind 
to treatment allocation; (b) all process and outcome assessors are blind to treatment 
allocation; (c) therapists are regularly reminded that they are not allowed to disclose 
treatment allocation to any member of the team; (d) patients and outcome assessors are 

asked to guess which treatment was given so that the effects of possible bias can be 
examined in the analysis; and (e) all outcome assessor interviews are audiotaped, and 30% 
randomly assigned tapes rerated by independent rates. If blindness is broken, all subsequent 
assessments will be carried out by an alternative assessor. If patients withdraw from 
treatment before the end of active treatment, dropout questionnaires are administered to 
both the patient and the therapist (Post Session Questionnaire, PSQ; [51]). In the course of 
the active phase of treatment, the HRSD is measured weekly, and self-report questionnaires 
are administered. Saliva samples and cognitive tasks are measured before the start of 
treatment and on weeks 4, 8, 12, and 16. The MINI and SIDP are measured at weeks 8 and 
16.  
  
After the completion of the active phase (16 weeks), the first four follow-up sessions include 
maintenance sessions with the therapist, HRSD administration, and completion of a battery 
of self-report questionnaires. The MINI is administered at the first and third follow-up 
meetings. The three subsequent follow-up sessions do not include sessions with the 
therapist, and are scheduled for two months after the last follow-up session (six months 
after the end of the active treatment phase of 16-weeks), one year after the end of the 
active phase, and two years after the end of the active phase. At these three additional 
follow-up sessions, the HRSD and the MINI clinical interviews are administered, and 
selfreport questionnaires are completed. In the first two additional follow-up sessions the 
SIDP clinical interviews is administered as well.  
  
Measures  
The primary outcome measure of the trial is the HRSD [41], a 17-item clinically administered 
measure assessing the severity of depression. The assigned score is calculated by summing 
up all 17 items. Using, among others, the measures listed below, we also assess secondary 
outcomes, such as self-reported symptoms (i.e., BDI; [49]; BAI, Beck Anxiety Inventory, 
OQ30), interpersonal functioning (i.e., IIP, Interpersonal Problems Inventory, ECR, 
Experience in Close Relationships), and quality of life (Q-LES-Q, Quality of Life Enjoyment and 
Satisfaction).  
We also assess several process measures, such as the working alliance (WAI, Working 
Alliance Inventory) and therapeutic interventions (MULTI, Multi-theoretical List of 
Therapeutic Interventions).  
  
Data analyses  
All analyses will follow the intention-to-treat principle. Characteristics of the treatment 
groups will be described at baseline. To examine the potential moderating influence of 
attachment anxiety and attachment avoidance on the effect of treatment condition on 
outcome, we will use a multilevel hierarchical linear model with observations nested within 
patients. We will test two 3-way interactions of time, treatment condition, and attachment 
orientation (anxiety, avoidance) in predicting HRSD during active treatment (until Week 16).  
  

Ethical considerations  
The study design, procedure, and informed consent form were approved by the University of 
Haifa ethical committee (approval number: 118/15, Date: 10/10/2015). Participants receive 
detailed information about the study procedure in an oral explanation and in writing. 
Participants receive complete information regarding the implications of their participation, 
including potential risks, inconvenience, and benefits, their ability to stop their participation 
at any time without adverse consequences, issues of confidentiality, etc. An elaborate data 
management plan ensures careful handling of confidential data in all stages of the research 
process. In case of a serious adverse event (e.g., critical suicide risk), the RISK protocol will 
be activated, and a special committee trained to handle such situations, including three 
licensed clinical psychologists, will immediately take charge.