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

NCT01851915 | Unknown

• 1 other identifier: RS2010/013
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Term Therapy for Outpatients Diagnosed With Major Depressive Disorder

Keywords

Major depression; Interpersonal psychotherapy; Cognitive Behavioral Therapy; Alliance; Return to Work

Outcome Measures

Primary Outcomes (2)

• Montgomery Asberg Depression Rating Scale (MADRS) ( Montgomery SA & Åsberg M. Br J Psychiatry 1979; 134:382-9)

  Clinician-rated depression symptoms before and after therapy

  Change from before treatment to after termination (14-15 weeks)

• Return to Work

  Sick leave will be measured by medical records and by checking the insurance system

  Change from before treatment and after termination (14-15 weeks).

Study Arms (2)

Cognitive Behavioral therapy (CBT)

ACTIVE COMPARATOR

Short term therapy for treatment of depression

Behavioral: Cognitive Behavioral Therapy

Interpersonal Psychotherapy (IPT)

EXPERIMENTAL

Interpersonal short term therapy for treatment of depression

Behavioral: Interpersonal Psychotherapy (IPT)

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

14 sessions psychological treatment for depression

Cognitive Behavioral therapy (CBT)

Interpersonal Psychotherapy (IPT) BEHAVIORAL

14 sessions psychological treatment for depression

Interpersonal Psychotherapy (IPT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• major depression

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead
• REHSAM: collaborator
• Västernorrland County Council, Sweden: collaborator
• Psychiatric clinic, Hospital of Sundsvall, Sweden: collaborator

Study Sites (1)

Psychiatric clinic, Hospital of Sundsvall

Sundsvall, S-85186, Sweden

RECRUITING

Related Publications (2)

• Alexandersson K, Wagberg M, Ekeblad A, Holmqvist R, Falkenstrom F. Session-to-session effects of therapist adherence and facilitative conditions on symptom change in CBT and IPT for depression. Psychother Res. 2023 Jan;33(1):57-69. doi: 10.1080/10503307.2022.2025626. Epub 2022 Jan 23.

  PMID: 35068364 DERIVED

• Falkenstrom F, Ekeblad A, Holmqvist R. Improvement of the working alliance in one treatment session predicts improvement of depressive symptoms by the next session. J Consult Clin Psychol. 2016 Aug;84(8):738-51. doi: 10.1037/ccp0000119. Epub 2016 May 23.

  PMID: 27213493 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral Therapy; Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Annika Ekeblad, PhD student

CONTACT

46705855746; annika.ekeblad@lvn.se

Rolf Holmqvist, professor

CONTACT

+4613281000; rolf.holmqvist@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical psychologist, PhD student

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: May 13, 2013
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

SE (1)