Depression
Conditions
Keywords
Cognitive behavior therapy, Psychodynamic therapy, Mediators, Moderators
Brief summary
Background: Major depressive disorder (MDD) is a prevalent psychiatric condition associated with significant disability, mortality and economic burden. MDD is ranked fourth in terms of disease burden as defined by the World Health Organization (2001). Cognitive Behavioral Therapy (CBT) and Psychodynamic Psychotherapy (PDT) are found to be equally effective for patients with depression. However, many patients do not respond sufficiently to treatment and relapse rates are high. To be able to offer individualized treatment, a clinically important question is therefore whether some patients profit more from one of the two therapies. At present little is known on which patient characteristics (moderators) may be associated with differential outcomes of CBT and PDT and through what kind of therapeutic processes and mechanisms (mediators) improvements occur in each therapy mode. There are actually only theoretical assumptions sparsely supported by research findings on what moderates and mediates the treatment effects of CBT and PDT. Aims: The overall aim of this project is to examine putative moderators and mediators in CBT and PDT and develop more basic knowledge about their impact on outcomes of psychotherapy for patients with MDD. Methods and study design: The study is a randomized clinical trial. One hundred patients will be randomized to one of two treatment conditions. The patients will be treated over 28 weeks with either CBT (one weekly session over 16 weeks and 3 booster sessions (monthly) during the rest of the 28 week study period) or PDT (one weekly session in 28 weeks). The patients will be evaluated at baseline, during therapy, at the end of therapy, and at follow-up investigations 1 and 3 years after treatment termination. The outcome measures comprise a large range of clinical and process variables, including assessment tools measuring specific preselected putative moderators and mediators. Discussion: The clinical outcome of this trial may guide clinicians to decide what kind of treatment should be offered the individual patient. Moreover, it will shed light on what kind of mechanisms in psychotherapy that is followed by symptom improvement and increased psychosocial functioning.
Interventions
OTHERCognitive behavior therapy
In this study we want to compare CBT and PDT and examine whether some patients will benefit from CBT and other from PDT. More specifically we want to examine moderators and mediators for improvement in depressive symptoms in the two interventions arms.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments will be provided by raters blinded to the randomization
Intervention model description
In this study we want to examine moderators and mediators in two equally effective, well known psychotherapeutic treatments (Psychodynamic and cognitive behavior therapy)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18-65 years, with depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV; American Psychiatric Association, 2000) unipolar MDD diagnosis will be included.MINI plus (Sheehan et al., 1998 will be used as assessment tool. Comorbidity is expected to be frequent. Written consent will be obtained from all patients. * The participants need to have the ability to speak and understand a Scandinavian language, and willingness and ability to give informed consent.
Exclusion criteria
* Current or past neurological illness, traumatic brain injury, current alcohol and/or substance dependency disorders, psychotic disorders, developmental disorders, and mental retardation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up | Assessment of depression |
| Beck Depression Index | Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up | Assessment of depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Cognitive Insight Score | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Assessment of cognitive insight |
| Global Assesment of Functioning | Change in scores during therapy and the follow-up periode (one and three years) | Assessment of global symptoms and functioning |
| Reflective functioning - depression | Change in scores during therapy and the follow-up periode (one and three years) | Assessment of reflective functioning |
| Dysfunctional Attitude Scale | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Measure of dysfunctional attitude |
| Metacognitive questionnaire | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Assessments of metacognition |
| Inventory of Interpersonal Problems | Change in scores during therapy and the follow-up periode (one and three years) | Measure of interpersonal problems |
| Psychodynamic Functioning Scale | Change in scores during therapy and the follow-up periode (one and three years) | Assesment of dynamic functioning |
Other
| Measure | Time frame | Description |
|---|---|---|
| Work and Social Adjustment Scale | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Assessment of functioning |
| Hypomani Checlist | Change in scores during therapy and the follow-up periode (one and three years) | Measures hypomanic symptoms |
| The Short Form Health Survey | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Measure of general Health issues |
| Childhood Trauma Questionnaire | Baseline (inclusion). Moderator of treatment | Measure of childhood trauma |
| Severity of Indices of personality Problems | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Assessments of personality dimensions |
| Toronto Alexithymia Scale | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Measures of alexithymia |
| Rumination respons scale | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Measures of ruminations |
| Structural Analysis of Social Behavior | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Measure social behavior |
| Experience in Close Relationship Inventory | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Functioning in Close relations |
| Patient Health questionnaire | Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up) | Measure anxiety |
Countries
Norway
Outcome results
None listed