All individual therapists were educated and trained in the basic principles of ISTDP, and instructed to adhere to these principles in individual sessions. Also, videotapes of all individual sessions are available for systematic adherence and competence evaluation. Patients also receive two weekly group sessions 90 minutes each.
These group sessions integrate the notion of pressure to feeling, and systematic clarification and challenge of defenses, with traditional group therapeutic principles [ 27 ]. There are also weekly body awareness training groups based on principles from psychomotor physiotherapy, along with bi-weekly low-intensity physical exercise walking , and weekly psycho-educational lectures providing a conceptual understanding of the therapeutic process. Finally, all patients take part in weekly art therapy groups focusing on the experience and expression of feelings through creative and artistic displays.
Individual psychomotor therapy is an optional addition offered to all patients at the start of treatment. Beyond the individual therapist, all patients are provided a primary treatment contact among the ward staff with whom they are encouraged to discuss important aspects of their development and potential challenges for the therapeutic process in a systematic and continuous fashion. The primary contact and other staff also implement treatment principles from ISTDP whenever suitable and indicated in the every day on-goings within the ward.
The research project is a naturalistic longitudinal study for examining the short- and long term effectiveness of this time-limited intensive in-patient treatment program for relieving treatment resistant conditions, mainly anxiety-, depressive-, and personality disorders. To increase confidence in our findings a naturalistic waitlist control condition is established. Thus, patients are assessed with self-rated measures prior to their evaluation session so that development from the time of evaluation until the onset of treatment can be used as a contrast to effects presumably attributable to the treatment itself.
In the treatment and follow-up phases, observer- and self-rated assessments are done in the week prior to hospitalization T1 , during the eight week treatment phase tt08 , at termination T2 , in addition to six T3 and twelve months T4 after the end of treatment. Individual psychotherapy sessions are videotaped for supervision purposes and made amenable to the application of observational coding systems for rating various process and outcome factors in treatment.
Experienced members of staff are specifically trained for assessing patients included in the treatment program on the relevant observer based measures which are conducted prior to hospitalization T1 , at termination T2 , and twelve months after termination T3. Finally, the Affect Consciousness Interview ACI [ 30 ] is used for assessing the functional level of affect integration and affect organization.
Using branching tree logic, the MINI has two to four screening questions per disorder. Additional symptom questions within each disorder section are asked only if the screen questions are positively endorsed. Since anxiety and depressive disorders are a central focus of the program, the presence or absence of such disorders will be used as specific measures of outcome from the treatment, along with diagnostic status on other relevant diagnostic categories in the MINI.
The scoring is done so that the trait either is absent, sub-threshold, true, or there is "inadequate information to code". Traits considered true are then summed up and diagnoses are indicated when the required number of traits are present for any given disorder. The SCID-II is administered by trained interviewers and generally yields decent indications of the personality disorder spectrum.
The ACI is a semi-structured interview designed for assessing the consciousness and integration of discrete affects Affect Consciousness - AC [ 30 , 31 ]. The interviewer asks about the following for each affect: 1 scenes in which the affect is activated, 2 how the patient becomes aware of and recognizes the affect, 3 how the affect impacts upon the patient, how the patient copes with the affect, and what information the patient decodes from the affect activation, 4 to what extent and how the affect is expressed in nonverbal forms i.
The interviews are administered by trained interviewers, videotaped, and scored according to criteria specified in the Affect Consciousness Scales ACSs [ 30 ]. A score of 1 is the lowest possible, 9 is the highest, and a score of 5 would be considered normal. On the basis of these indicators, scores on three different levels are calculated: Overall mean score Global AC , mean score on each of the four integrating aspects e. A number of self-rated questionnaires are completed prior to the evaluation session, prior to treatment onset, and throughout the treatment- and follow-up phases, reflecting various aspects of patient functioning and therapeutic process.
One questionnaire assesses basic demographic information, along with information on prior treatment, educational level, current occupational status, the use of medications, and current financial situation. The OQ is first administered before the evaluation session, in the week before onset of treatment, and then before every single individual psychotherapy session throughout the treatment phase, as well as six and twelve months after termination.
In addition, the Symptom Checklist Revised [ 33 ] SCLR , and the Inventory of Interpersonal Problems IIP [ 34 ] are used prior to evaluation, before onset of treatment, in weeks two and five of treatment, at termination, and six and twelve months after termination.
The Working Alliance Inventory, patient version WAI-P [ 35 ] is used as a measure of conscious working alliance and is administered in week two, five, and at termination. The OQ is a symptom and distress inventory developed by Lambert et al. It has been found to be useful for examining the effectiveness of psychotherapy over time [ 36 ]. The instrument is designed to assess "patient functioning" and scores are used to track changes in symptomatology on a session-by-session basis.
The OQ consists of 45 items tapping various aspects of psychological distress each associated with a 5-point Likert scale. Responses refer to the last seven days and range from "never" to "almost always". Once responses to nine negatively worded items have been reverse-coded, sum scores are calculated with higher scores representing increasing levels of psychopathology. The SCLR is a widely used and comprehensive symptom inventory that measures symptom distress on nine dimensions and three global indexes [ 33 ].
Intensity of 90 symptoms during the last seven days is rated on a five point Likert scale ranging from not at all 0 to very much 4. The Global Severity Index GSI , the average score across all 90 items, is regarded a highly nuanced and valuable indicator of overall current level of distress [ 37 ].
The depression-, anxiety-, and phobic anxiety- subscales will be used as specific outcome measures of these, to the program, central outcome dimensions. General and specific interpersonal problems are assessed using the 64 item IIP-circumplex version [ 34 ]. The IIP consists of two types of items. The first 39 items begin with the phrase: "It is hard for me to…" The remaining 25 items represent "Things that you do too much.
The general or elevation factor of the IIP has been consistently linked to both symptom severity and negative affectivity [ 38 ]. The second Agency and third Communion factors, yielding the IIP circumplex structure, generally show good construct validity in terms of fit with a quasi-circumplex model, along with distinct convergent-discriminant correlation patterns with different forms of personality pathology, supporting the notion that the IIP model adequately represents its theoretically alleged distinctions in interpersonal functioning [ 31 , 39 ].
The overall score of the IIP is used as an indicator of general interpersonal problems. Patient rated working alliance is assessed by the Working Alliance Inventory WAI [ 31 ] short version with 12 items rated on a seven point scale [ 40 ]. The WAI covers three aspects of working alliance: therapeutic bond, task, and goal. The goals subscale assesses the extent to which patient and therapist agree on the goals that are the target of the intervention.
The tasks subscale assesses the extent to which patient and therapist agree on the in-counseling behaviors and ideas that form the substance of the counseling process.
The bond subscale assesses the extent to which patient and therapist share mutual trust, acceptance, and confidence in the process at hand. The research project is designed to include a minimum of patients; however, all patients treated at the unit are invited to participate, so the sample size is expected to increase further over time. In research where demonstrating the effectiveness of treatment is an objective, statistical power will always be an important factor. Exact estimation of statistical power is only possible for specific analytic designs aimed at delimited research questions and necessarily based on conditions that are not exhaustively known when a study is initiated.
However, in general a sample of patients will yield a statistical power of. This estimate will also apply to change scores between to points of measurement if we assume that the average correlation between time-points is greater than. The data from the project lends itself to various research topics.
Most centrally, the data can contribute valuable knowledge on the effectiveness of short-term and time-limited residential treatment for treatment resistant psychiatric conditions. For answering this research question using continuous outcome variables e. The application of multilevel modeling for the analysis of longitudinal data, in this case repeated measurements on the same individuals, is strongly recommended in the literature [ 41 , 42 ].
For longitudinal data, measurements are nested within individuals, so that measurements represent units at the first level and individuals represent units at the second. It is usually proposed that as requirements for longitudinal analyses, all variables must be collected at three or more measurement waves, that a continuous outcome changes systematically over time, and that a meaningful unit for time is included [ 42 ]. Each of these requirements is met by the design of the present project.
Generally, based on experiences with previous patients going through the program we expect low attrition rates. Almost all patients are expected to complete the treatment program and deliver data for the complete treatment phase. For dichotomous outcome variables e. Treatment response for individual patients on self-rated instruments is defined in terms of clinically significant change CSC according to Jacobson and Truax [ 3 ].
Thus, we will identify the number of patients that are reliably improved and have moved from the dysfunctional to the functional range recovered , the number of patients reliably improved but not recovered, the number of patients reliably worsened, and the number of patients unchanged on central outcome measures. The data also lend themselves to a number of investigations into the conceptual and empirical relationships between various measures of psychological health and functioning, and to tests of the psychometric properties of different measures included in the study, e.
For such investigations traditional exploratory and semi-confirmatory factor analyses, multiple linear regression models, and correlation analyses will be performed.
Since anxiety and depressive disorders are a central focus of the program, the presence or absence of such disorders will be used as specific measures of outcome from the treatment, along with diagnostic status on other relevant diagnostic categories in the MINI. Hox J: Multilevel analysis. Another issue refers to the rating perspective. Systematic knowledge regarding the question what kind of verbal techniques a therapist should or should not apply in his or her therapeutic work is of major practical importance. Which assessment mode is employed and which rating perspectives are considered? The bond subscale assesses the extent to which patient and therapist share mutual trust, acceptance, and confidence in the process at hand.
Finally, data may prove to be a valuable source of information on the predictors of change and treatment response when treating treatment resistant patients. For answering research questions related to this topic, individual growth curves will be utilized and relevant predictors entered into the multilevel models of change. Participation in the research part of the program is voluntary.
Participants are informed that they can withdraw their consent to participate at any time without disclosing reasons for their cancellation.
There are no negative consequences of such withdrawal for the treatment delivered. All participants sign a written and informed consent. The protocol for the study was evaluated by the Regional Committee for Medical and Health Research Ethics in Eastern Norway and a letter of exemption was issued classifying the study as a quality control project approving dissemination of results.
The Drammen Project has as its core a systematic treatment program directed at patients who have not profited adequately from previous treatment attempts. Included patients primarily suffer from anxiety or depressive disorders, and usually, but not always, from comorbid personality disorders. The project furthermore entails a naturalistic longitudinal research design which systematically evaluates the effectiveness of the treatment program.
To our knowledge, this is the first treatment program and corresponding research project that systematically selects patients with previous non- or negative response to treatment and subjects them to a broad and comprehensive, but theoretically unified and consistent treatment system. The project thus carries the potential of yielding important and novel knowledge about the treatment of non-responders to psychiatric care and the potential for succeeding with them through intensive and systematic intervention.
Furthermore, the program is one of very few that applies principles from ISTDP across a variety of treatment components within a residential setting. Results from the Drammen Project will thus be a valuable complement to the promising findings already reported on residential ISTDP [ 22 ]. The protocol presented here gives an in depth description of the treatment program and the corresponding research design. It offers a comprehensive source of background information pertinent to the Drammen Project and any publications that will arise from it.
It thus will serve as a central reference that contains more detailed information on the methodological and design qualities of the project than is possible in later research publications and make these qualities available for critical review.