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A Randomized Controlled Trial of Behavioral Activation and Treatment As Usual in the Acute Treatments of Adults with Major Depressive Disorder.

A Randomized Controlled Trial of Behavioral Activation and Treatment As Usual in the Acute Treatments of Adults with Major Depressive Disorder.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT138807192573N1
Enrollment
100
Registered
2010-01-16
Start date
2009-10-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder. Depressive episode

Interventions

Intervention 1: In behavioral activation group, 16 sessions of BA treatment, for the first month every week two sessions 50 minutes and for the second and third months of the treatment, every week one
Behavior
Treatment - Drugs
In behavioral activation group, 16 sessions of BA treatment, for the first month every week two sessions 50 minutes and for the second and third months of the treatment, every week one session will be
Sertraline 25 mg daily for the first week, 50 mg for the second and third weeks, 75 mg for the fourth and fifth weeks and 100 mg for the sixth week and until the end of the treatment.

Sponsors

Medical university of Kurdistan and Maastricht University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria : diagnosis of major depression according to the SCID-I, severity above 19 on the BDI and 13 on the HRSD, age 18-70, written consent to participate with the study. Exclusion criteria : if they have a life time diagnosis of bipolar disorder, organic brain syndrome, psychosis or mental retardation. Additional exclusion criteria are: substantial and imminent suicide risk; a current (e.g., within the past six months) or primary diagnosis of alcohol or drug abuse or dependence or a positive toxicology screen; a primary diagnosis of panic disorder, obsessive-compulsive disorder, psychogenic pain disorder, anorexia, or bulimia. In addition, participants who did not respond favorably within the preceeding year to medication will be excluded. Participants who have unstable medical condition and using any medication that would complicate the administration of antidepressant medication (medication in my study), or have a known allergy to medication in this study will be excluded. Moreover, women who are pregnant or maybe want to be pregnant will be excluded. Lastly, participants have to able to read and understand the questionnaires and interviews used in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Treatment of major depressive disorder. Timepoint: Before intervention, in the middle of Intervention (45 days after starting treatment) and after treament ( after 3 months treatment duration).). Method of measurement: In BA, by BDI-II and In TAU, HRSD is used.

Secondary

MeasureTime frame
Prevention and relapse of major depressive disorder. Timepoint: One year after termination of the treatment. Method of measurement: In BA, by BDI-II and In TAU, HRSD is used.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLatif Moradveisi

Maastricht University

latif.moradveisi@maastrichtuniversity.nl+98 918 784 8047

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 24, 2026