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Trial record 21 of 5357 for:    "Depressive Disorder" [DISEASE] AND Behavioral

Cognitive Behavioral Therapy and Interpersonal Psychotherapy as Treatment for Major Depressive Disorder (CIPPS)

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ClinicalTrials.gov Identifier: NCT01851915
Recruitment Status : Unknown
Verified May 2013 by Annika Ekeblad, Linkoeping University.
Recruitment status was:  Recruiting
First Posted : May 13, 2013
Last Update Posted : May 13, 2013
Sponsor:
Collaborators:
REHSAM
Västernorrland County Council, Sweden
Psychiatric clinic, Hospital of Sundsvall, Sweden
Information provided by (Responsible Party):
Annika Ekeblad, Linkoeping University

Brief 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.

Condition or disease Intervention/treatment Phase
Short Term Therapy for Outpatients Diagnosed With Major Depressive Disorder Behavioral: Cognitive Behavioral Therapy Behavioral: Interpersonal Psychotherapy (IPT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Treatment of Depression With Interpersonal Psychotherapy and Cognitive Behavioral Therapy
Study Start Date : January 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cognitive Behavioral therapy (CBT)
Short term therapy for treatment of depression
Behavioral: Cognitive Behavioral Therapy
14 sessions psychological treatment for depression

Experimental: Interpersonal Psychotherapy (IPT)
Interpersonal short term therapy for treatment of depression
Behavioral: Interpersonal Psychotherapy (IPT)
14 sessions psychological treatment for depression




Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS) ( Montgomery SA & Åsberg M. Br J Psychiatry 1979; 134:382-9) [ Time Frame: Change from before treatment to after termination (14-15 weeks) ]
    Clinician-rated depression symptoms before and after therapy

  2. Return to Work [ Time Frame: Change from before treatment and after termination (14-15 weeks). ]
    Sick leave will be measured by medical records and by checking the insurance system



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-major depression

Exclusion Criteria:

  • psychosis
  • addiction
  • bipolar disorder
  • active self harm
  • severe attention deficit hyperactivity syndrome
  • disability pension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851915


Contacts
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Contact: Annika Ekeblad, PhD student 46705855746 annika.ekeblad@lvn.se
Contact: Rolf Holmqvist, professor +4613281000 rolf.holmqvist@liu.se

Locations
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Sweden
Psychiatric clinic, Hospital of Sundsvall Recruiting
Sundsvall, Sweden, S-85186
Contact: Annika Ekeblad    +46705855746    annika.ekeblad@lvn.se   
Sponsors and Collaborators
Linkoeping University
REHSAM
Västernorrland County Council, Sweden
Psychiatric clinic, Hospital of Sundsvall, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Annika Ekeblad, clinical psychologist, PhD student, Linkoeping University
ClinicalTrials.gov Identifier: NCT01851915     History of Changes
Other Study ID Numbers: RS2010/013
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Annika Ekeblad, Linkoeping University:
Major depression
Interpersonal psychotherapy
Cognitive Behavioral Therapy
Alliance
Return to Work

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms