Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01851915 |
| Other study ID # |
RS2010/013 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
March 11, 2013 |
| Last updated |
May 10, 2013 |
| Start date |
January 2011 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
May 2013 |
| Source |
Linkoeping University |
| Contact |
Annika Ekeblad, PhD student |
| Phone |
46705855746 |
| Email |
annika.ekeblad[@]lvn.se |
| Is FDA regulated |
No |
| Health authority |
Sweden: Regional Ethical Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
In this study, the differential effectiveness of CBT and IPT for patients with Major
Depressive Disorder, who rate their depression as mild or moderate, will be studied. Both
methods are evidence based and recommended by the National Board of Health in Sweden. They
are manual based and the patients will receive 14 sessions in each therapy. Their
comparative effectiveness has not been studied in Sweden, and their effectiveness with
regard to work capacity has not been tested. The hypotheses in the study are that they have
equal effect for depression remission, but that CBT is superior when return to work is
measured. Three moderator analyses, testing effects for different subgroups, will be made.
They propose that patients with attachment avoidance and lower mentalization ability and
male patients will have better outcome with CBT. The study will be performed at Sundsvall
Hospital, in cooperation with Linköping University. Sundsvall hospital is the only hospital
in Sweden where there is a group IPT therapists large enough to make a controlled study
possible. The study has a randomized design, with 16 therapists, 8 of them delivering CBT
and 8 IPT. The number of patients is 96. The statistical power is .87, with a hypothesized
between-groups effect size of d = .40 for return to work, and the significance level of .05
for the between-groups difference. Outcome will be measured as remission of psychiatric
diagnosis, decrease in depression severity and frequency of patients who return to work.
Both intent-to-treat and completers analyses will be made. The project will go over two
years. The study has an effectiveness character in the sense that treatments, although
manual based, will be performed in the manner that the therapists usually work, and by
having broad inclusion criteria. Treatment integrity will be ascertained by therapist
reports and by filming sessions.
Description:
The main purpose of the study is to analyze whether Interpersonal psychotherapy (IPT) and
Cognitive Behavioural Therapy (CBT) are effective psychotherapies for depressed patients,
with respect to changes in working capacity and psychiatric diagnosis. A secondary purpose
is to study moderating factors in the two methods. The study has a randomized design. It
will be performed at the Psychiatric Clinic in Sundsvall.
The differences in effect between different forms of psychotherapy for depression, when
reduction in symptoms is used as outcome criterion, are rather small. In a recent
meta-analysis, differences in efficacy between seven forms of psychotherapy were compared
(Cuijpers, van Straten, Andersson & van Oppen, 2008). The efficacy was on the whole the
same.
In the guidelines from National Board of Health and Welfare in Sweden, CBT and IPT are
recommended as the first hand choices for treatment of mild and moderate depression. This
recommendation is based on studies from other countries. Comparative randomized studies of
CBT and IPT have not been published in Sweden.
Hypotheses The main hypotheses in this study is that CBT and IPT are both effective
treatments for Major Depressive Disorder, and that they have equal effects with regard to
remission from depression, but that CBT is more effective than IPT when return to employment
is the outcome measure. Three moderator hypotheses will be tested. The first moderator
hypothesis is that patients with attachment avoidance get better results with CBT, whereas
patients with attachment anxiety get better results with IPT. The second hypothesis is that
patients with higher RF get better results with IPT than with CBT. The third moderator
hypothesis is that women respond better to IPT and men to CBT, particularly if relational
functioning is considered. In the moderator hypotheses, both remission from depression and
return to work will be outcome criteria.
Method Participants Patients who seek treatment with the diagnosis Major Depressive Disorder
(MDD), and who indicate mild or moderate depression on Beck's Depression Inventory will be
asked to participate. The inclusion criterion is thus Major depressive disorder with mild or
moderate severity. Exclusion criteria are psychosis, ongoing drug abuse, serious
neuropsychiatric disorder, personality disorder cluster B. Patients with severe depression
will also be excluded. We will also exclude patients who have used the disability pension
and only include patients who have sickness benefit, as it is improbable the psychotherapy
with 14 sessions will be enough for patients with disability pension. There will be no
treatment arm with only medication. Ongoing medication is no obstacle for participation, but
changes in medication will be avoided if possible. Medication will be registered. The
patients will be randomized to the treatment alternatives. In all, 96 patients will take
part in the study.
Sixteen therapists will participate in the study. Eight of them will give CBT and eight will
give IPT. The therapists have at least the basic level of psychotherapy training according
to Swedish norms. They are psychologists, social workers, and psychiatric nurses. They have
been trained in their respective methods, have experience in it and have ongoing
supervision, which will continue during the study.
Treatments Interpersonal therapy (IPT) will be delivered according to the standard manual
(Weissman, Klerman & Markowitz, 2000). IPT is a manualized, problem-focused treatment,
originally created for depression treatment but now also using manuals for other disorders.
The working mechanism of the treatment is supposed to be the patient's increased ability to
connect the mood with interpersonal events, thus enabling him or her to influence the mood
by solving interpersonal problems. Four distinct problem areas have been defined as
associated with depression. The patient and the therapist start the treatment with
identifying the patient's psychiatric and interpersonal problems. At the end of the
introductory phase, a problem area is selected as the main focus. The remaining sessions, up
to the termination phase, are devoted to helping the patient to find ways of handling the
selected problem. The therapy will include 14 sessions.
Cognitive behavior therapy will be delivered according to the manuals of a) behavior
activation during 14 sessions (Jacobson, Martell & Dimidjian 2001) and b) Cognitive therapy
for depression according to Beck et al. Behavior activation is based on a contextual model
of depression, where the link between avoidant behavior and depression is the focus and the
change mechanism is supposed to be activation strategies aiming to undermine punishment and
increase positive reinforcement from the environment. The conceptualization of depression
emphasizes the relationship between activity and mood and the role of contextual changes
which may lead to decreased access to reinforcers associated with depression. The model
underlines the importance of patterns of avoidance and withdrawal (e.g., of interpersonal
situations, occupational or daily-life routine demands, distressing thoughts or feelings).
Contacting potential antidepressant reinforcers may often be experienced as initially
punishing, and thus avoidance of contact minimizes distress in the short term but is
associated with greater long-term difficulty, both by reducing opportunities to contact
potentially antidepressant environmental reinforcers and by creating or exacerbating new
problems secondary to the decreased activity. Increased activation is presented as a
strategy to break this cycle (Martell, Addis & Jacobson, 2001). Some therapist are going to
include mindfulness in their CBT as well.
The design has effectiveness character in the sense that the exclusion criteria are few and
the therapies, although manual based, will be carried out in the manner that they are
usually carried out at this clinic. We will endeavour to ascertain that the therapies are
performed with accuracy, by having supervision on each therapy form. Adherence will be rated
by the therapists after each session and by filming a limited number of therapies from each
therapist, in order to ascertain treatment integrity. The Collaborative Study Psychotherapy
Rating Scale-6 (CSPRS-6; Markowitz, Spielman, Scarvalone & Perry, 2000), which is the
standard scale for rating adherence to CBT and IPT, will be used.
In both therapy forms, the treatments last for 14 sessions. Outcome will be evaluated at
treatment termination.
The inclusion of participants started in January 2011 and continues throughout the fall
2013.
