Mechanisms of Change in Psychotherapy

Depression Clinical Trial

— MOP  

Official title:

What Works for Whom and How? Mechanisms of Change in Psychotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03022071
• Other study ID #: What works for whom and how?
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Oslo University Hospital
• Contact: Jan I Røssberg, PhD
• Phone: +47 47876866
• Email: j.i.rossberg[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

Other:
• Cognitive 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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Work and Social Adjustment Scale	Assessment of functioning	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Other	The Short Form Health Survey	Measure of general Health issues	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Other	Childhood Trauma Questionnaire	Measure of childhood trauma	Baseline (inclusion). Moderator of treatment
Other	Severity of Indices of personality Problems	Assessments of personality dimensions	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Other	Toronto Alexithymia Scale	Measures of alexithymia	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Other	Rumination respons scale	Measures of ruminations	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Other	Structural Analysis of Social Behavior	Measure 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)
Other	Experience in Close Relationship Inventory	Functioning in Close relations	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Other	Patient Health questionnaire	Measure anxiety	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Other	Hypomani Checlist	Measures hypomanic symptoms	Change in scores during therapy and the follow-up periode (one and three years)
Primary	Hamilton Depression Rating Scale	Assessment of depression	Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up
Primary	Beck Depression Index	Assessment of depression	Change in scores between baseline and 28 weeks (end of therapy) and change between baseline and one and three year follow-up
Secondary	Psychodynamic Functioning Scale	Assesment of dynamic functioning	Change in scores during therapy and the follow-up periode (one and three years)
Secondary	Beck Cognitive Insight Score	Assessment of cognitive insight	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Secondary	Global Assesment of Functioning	Assessment of global symptoms and functioning	Change in scores during therapy and the follow-up periode (one and three years)
Secondary	Inventory of Interpersonal Problems	Measure of interpersonal problems	Change in scores during therapy and the follow-up periode (one and three years)
Secondary	Reflective functioning - depression	Assessment of reflective functioning	Change in scores during therapy and the follow-up periode (one and three years)
Secondary	Dysfunctional Attitude Scale	Measure of dysfunctional attitude	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)
Secondary	Metacognitive questionnaire	Assessments of metacognition	Change in scores during therapy and the follow-up periode (8 weeks, 16 weeks, 28 weeks, 1 year and 3 year follow up)