Protocol summary

Summary
Introduction: In addition to traditional methods of drug therapy, a lot of discussion has been done recently about the third wave of cognitive and behavioral approaches for treating depression. Therefore this study was done aimed to compare effectiveness of acceptance and commitment therapy and drug therapy on improving patients with major depression. Methods: Design of this study was semi-experimental type as pretest-posttest with two experiment groups and one control group. Statistical population consisted of all patients with major depression treated in of Shahrekord city welfare centers in 2015 year. The sample studied were all 45 people of from patients who were selected through random sampling method and were divided into three groups- under training with acceptance and commitment therapy, drug therapy group and one control group. For collection data was used from Beck Depression Inventory (BDI). Data Analyzing was conducted with covariance and Scheffe post hoc test and SPSS. Results: The mean post-test of the psychotherapy group was 12/40, drug therapy group 23/13 and control group 36/27. The results showed there were significant differences between experiment groups of acceptance and commitment therapy and drug therapy and control group (F= 110/33, p<0/001) and acceptance and commitment therapy and drug therapy have significant effect in reducing of major depression. Also, the results showed that acceptance and commitment therapy have more effective than drug therapy in reducing depression. Conclusions: According to the findings this study, can suggested acceptance and commitment therapy and drug therapy as an effective way and a useful clinical intervention in improving depression besides drug therapy. Keywords: acceptance and commitment, psychotherapy, drug therapy, depression.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070334862N1
Registration date: 2017-07-19, 1396/04/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-19, 1396/04/28
Registrant information
Name
Rasoul Alipour
Name of organization / entity
Islamic Azad University, Bandar Abbas
Country
Iran (Islamic Republic of)
Phone
+98 913 721 0585
Email address
rasul69.a@gmail.com
Recruitment status
Recruitment complete
Funding source
research fellow
Expected recruitment start date
2015-03-30, 1394/01/10
Expected recruitment end date
2015-04-13, 1394/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effectiveness of acceptance and commitment therapy (ACT) and drug therapy on improving patients with major depression
Public title
Comparison effectiveness of acceptance and commitment therapy (ACT) and drug therapy on depression
Purpose
Treatment
Inclusion/Exclusion criteria
(1) Aims: The aim of this study was to compare the efficacy of group therapy based on admission and commitment and drug therapy on the improvement of patients with major depression. (2) Design: The research design was semi-experimental and pre-test-posttest with two experimental groups and one control group. (3) How to do it (3) Setting and conduct (4) Participants: The statistical population of the study included all patients with major depressive disorder in Shahrekord's well-being care centers in 1994. The study sample consisted of 45 patients who were selected by convenience sampling and randomly assigned to two experimental groups with acceptance and commitment and drug therapy and one control group. Beck Depression Scale (BDI) and Coopersmith's Self-Esteem Questionnaire were used for data collection in pre-test and post-test. Data were analyzed by analysis of univariate covariance and Scheffe post hoc test and SPSS software. (5) interventions: group therapy based on acceptance and commitment and medication (6) Main outcome variables: Signs of major depression, self-esteem
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The study sample consisted of 45 patients who were selected by convenience sampling and randomly assigned to two experimental groups with acceptance and commitment and drug therapy and one control group.

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas Azad University
Street address
Bandar Abbas Crossroads Paladin Campus-Blvd Campus-Islamic Azad University Bandar Abbas
City
Bandar Abbas
Postal code
Approval date
2014-01-12, 1392/10/22
Ethics committee reference number
73/397158

Health conditions studied

1

Description of health condition studied
Major depressive disorder
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms

Primary outcomes

1

Description
Symptoms of depression
Timepoint
Pre-test and post-test intervals of one month
Method of measurement
The Beck Depression Scale (BDI) was used to collect data. Data were analyzed by analysis of univariate covariance and Scheffe post hoc test and SPSS software.

Secondary outcomes

1

Description
Self-esteem
Timepoint
Pre-test and post-test intervals of one month
Method of measurement
The score is the score that the subjects earned in the Cooper Smith self-esteem questionnaire. Data were analyzed by analyzing univariate covariance and Scheffe post hoc test and SPSS software.

Intervention groups

1

Description
Acceptance and Commitment Group Therapy: In this research, the Acceptance and Commitment-based Treatment Group (ACT) is an 8-session intervention program (90 minutes each week), in which the members of the group gather together, And with the help of the group leader, they will discuss issues related to the acceptance of emotions, achievement of goals, impulse control, awareness raising, access to emotional regulation strategies, and clarification and clarification of problems, and carry out related assignments.
Category
Treatment - Other

2

Description
Medication Constant dose intake of antidepressants including triple tyline (alivyl), trimimipramine (surmontelium) and alprazolam was monitored and administered by a psychiatrist by psychiatric and psychiatric patients who were diagnosed with major depressive disorder (MDD) Theoretical definition: The approach to drug therapy for mood disorders has transformed their treatment and reduced its inherent costs for the community. Antidepressants are increasingly prescribed to treat depression disorders. Among the most important of these are monoamine oxidase inhibitors, tri-drug drugs, serotonin reuptake inhibitors Operational Definition: A constant dose of antidepressants including triple tyline (alavil), trimimperamine (surmontelyl), and alprazolam were monitored and administered by a psychiatrist by psychiatric and psychiatric patients who were under the Major Depression Scale (MDD) under the well-being of Shahrekord.
Category
Treatment - Drugs

3

Description
The control group did not receive any kind of treatment, but the control group was told that after the research they could attend admissions and admission treatment sessions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Welfare Organization of Shahrekord City
Full name of responsible person
Firuze maleki
Street address
Shahr-e-Kord: Northern Hafez Street above the post office of the 437th post office
City
Shahr-e-Kord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research of Bandar Abbas Azad University
Full name of responsible person
Kobra Haji Alizadeh
Street address
Bandar Abbas Crossroads Paladin Campus-Blvd Campus-Islamic Azad University Bandar Abbas
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Bandar Abbas Azad University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Bandar Abbas Azad University
Full name of responsible person
Rasoul Alipour
Position
MA
Other areas of specialty/work
Street address
Shahr-e-Kord - The western nation originates 16 meters second to the glass of Berri Bahramian
City
Shahr-e-Kord
Postal code
Phone
+98 913 721 0585
Fax
Email
rasul69.a@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandar Abbas Azad University
Full name of responsible person
Kobra Haji Alizadeh
Position
Assistant Professor and deputy director of Azad University of Bandar Abbas
Other areas of specialty/work
Street address
Bandar Abbas Azad University
City
Bandar Abbas
Postal code
Phone
+98 71 1666 5500
Fax
Email
Ph_alizadeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bandar Abbas Azad University
Full name of responsible person
Rasoul Alipour
Position
MA
Other areas of specialty/work
Street address
Shahr-e-Kord - The western nation originates 16 meters second to the glass of Berri Bahramia
City
Shahr-e-Kord
Postal code
Phone
+98 38 3225 7021
Fax
Email
rasul69.a@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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