Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00883207 |
| Other study ID # |
DINADEP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
February 2006 |
| Est. completion date |
October 2009 |
Study information
| Verified date |
August 2023 |
| Source |
University of Jyvaskyla |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main aim of the project is to develop couple therapy for depression with special interest
in dialogical and narrative processes in therapy. Parenthood, and different psychosocial
phenomena, such as domestic violence, suicidal behaviour and alcohol abuse in relation to the
client's specific depressive state will be analysed. The second main aim of the study is to
analyse the effectiveness couple therapy for depression as a real world study. The good and
poor outcome of different therapy processes will be compared and thus information about
precise change processes will be reached. Owing to the real world setting, the inclusion
criterion is a broad one: a primary diagnosis of depression (F32 and F33 in ICD-10).
The project will be conducted as a multicentre study so that in each centre the included
patients will be randomized into experiment and control groups. The study centres are (1)
Pohjois-Savon sairaanhoitopiiri in Kuopio, (2) Länsi-Pohjan sairaanhoitopiiri in Tornio and
Kemi and (3) HUS/ Jorvin sairaala regional psychiatric polyclinics in Espoo. In each province
the entire adult population has free access to the psychiatric outpatient clinics in their
specific catchment area and thus no selection for the patients is done.
Description:
In each of these research centres qualified family therapists will conduct the couple therapy
in case of depressed patients in a team of two therapists. To be a responsible therapist in
this study the minimum criterion is three years specialist- level family therapy training and
thus a qualification as psychotherapist according to Finnish law. The therapist shall have
special experience and interest in dialogical and narrative processes in therapy. All the
family therapists will also have taken a training program that focuses on systemic family
therapy, narrative therapies and open dialogue in a family setting. No special therapy manual
has been written, but the treatment processes will be analyzed after the therapy in relation
to the outcome. The treatment processes are expected to last for as long as required
according to the specific needs of each couple. This will allow for the focus on external
validity: Clients will be recruited in the course of daily clinical practice without any
selection outside the diagnosis and the therapies are taking place for as long as needed. The
analyses of the treatment processes in relation to outcome, has termed as progress research
by Pinsof & Wynne (2000)
In couple therapy some guidelines are followed. Since every family therapist has training in
systemic therapy, the therapy can be termed as systemic couple therapy with a special focus
on dialogues and narratives. The two therapists and the couple form a system in which the
first aim is to generate dialogue to increase understanding of couple's situation and the
role of depression in their lives. To this end, spouses are encouraged to speak of subjects
that they find most important. While one person is speaking, the other three take a
reflective position in their inner dialogues and afterwards describe their thoughts about
what was said. The shift between the speaking and listening positions in the topics that the
couple choose is the basic element in each therapy process. In these processes a new joint
language is created for experiences without words or experiences manifested in symptoms,
marital problems or in problematic behaviour.
Three types of analysis will be conducted:
1. The effectiveness of systemic couple therapy will be analyzed by (a) the assessment of
depression by the Hamilton Depression Rating Scale inventory and the BDI and SCL
self-report ratings scales; (b) the assessment of couple satisfaction by the Dyadic
Adjustment Scale (DAS) self-report rating scale; and (c) the assessment of the
psychological status of the patient by GAF rating. In addition to these, (e) domestic
violence, use of alcohol and other psychosocial factors will be analyzed in interviews.
Assessments will be conducted before the outset of the treatment, after 6 months, after
12 months and after 18 months from the beginning of the treatment. Changes in the scales
between experiment and control groups will be compared. Because of the small size of the
experimental group and the naturalistic design, no noteworthy differences in the results
are expected as such. To test hypothetical explanatory power a prove was conducted. In
the power calculation, a hypothetical sample of 35 received the value .82 in cases where
the mean difference between two measurements divided by the corresponding standard
deviation was 0.6. Similarly, if the difference in the means between two measurements
was 0.5, the explanatory power was .66. Differences that are strong enough cannot be
expected if only the group differences in the mean values between two measurements are
analyzed without relating the results to the therapy processes (point 2) and to the
processes of change (point 3). The explanatory power may be higher, however, after the
Swedish study site has been added to the sample. The entire sample size would then
consist of about 55 patients in each group.
2. Treatment processes will be studied by analysing (a) video or audio recordings of the
dialogues and (b) the entire treatment processes in a specific follow-up interview three
months after termination of the couple therapy. This interview will be organized as a
learning forum, that is, the follow-up interviews will be conducted in a way that
enables the therapists to evaluate their work together with the couple and an outsider
interviewer. The aim is at developing the family therapists' therapeutic skills.
Reflective processes and learning on the part of the families are essential in this
co-research practice (Andersen 2006). The family and all staff members included in the
specific treatment process will be invited to this interview. First the therapy team
will be interviewed about their experiences of the treatment, and then the family
members will be interviewed about their experiences of the therapy and about their
thoughts regarding the therapists' experiences. The aim of this interview is to gain
information about the specific processes through which clients can perform their own
psychological work with their problems.
3. Processes of changes will be studied by conducting (a) a Outcome Ratings Scale among
clients before each session and a Session Rating Scale among both clients and therapists
after each therapy session and; and by (b) analyzing the qualities of the couple
therapies by Psychotherapy Q-Sort (PQS) categories (Jones & Jones, 1985). In the PQS 100
characteristics in 9 categories will be analyzed for one therapy session. The
characteristics describe 1) attitude, behaviour and explicative experience of the
patient; 2) actions and attitudes of the therapists; and 3) the nature of the
therapeutic relationship, environment and atmosphere of the session (Sirigatti, 2004).
Although the PQS has mostly been used in analysing manualized psychotherapies (Ablon &
Jones, 2002), implications has recently been developed for non-prescriptive therapies
(Ablon et al., 2005) and systemic therapy (Sirigatti, 2004). Both analyses will be
related to the outcome of the couple therapies and thus systematic information will be
obtained as to which type of dialogues are connected with good outcomes.
Control group is formed in each of the three centres. These clients will not have family
therapy sessions during the first 12 months; instead, according to the manner usual in each
centre they will visit a psychiatrist or other therapists. Clients will be randomly assigned
to the experimental and control groups after the doctor admitting them has assessed their
inclusion by diagnosis and the Hamilton Rating Scale and after the first research interview
has been conducted.
The inclusion period started in February 2006 and lasted until summer 2007. The first
follow-up interviews will continue until the end of 2009. In this specific project the
analysis of the data will begin in 2007 and continue to the end of 2010 concerning this
specific project. Thereafter the data will be available for post graduate and doctoral
students under the supervision of the principal investigators.
Department of Psychology at the University of Jyväskylä is the study site, in which all the
data will be gathered. In each centre the research data will be stored outside of patient
records. Information of the ratings scales can be added to specific patient records.
