Comparison of the effectiveness of exposure and response prevention method and acceptance and commitment therapy on recovery of patients with obsessive-compulsive disorder receiving sertraline.
The purpose of the study: Comparative effects of exposure and response prevention and acceptance and commitment therapy among patients with obsessive-compulsive disorder receiving sertraline. Design of the study: An experimental design using pre and post-test and a three-month follow up was used. The study population: all patients referred to private and public institutions at Sanandaj city who are being diagnosed by obsessive-compulsive psychiatrists and are under medical treatment for this disorder. The sample includes 45 people. The sampling method is purposeful in a manner accessible, and random allocation based on block redundancy is carried out on 15 individuals per block and three blocks. The random allocation will be as follows: Persons who get the Yale Brown score of 16 or higher will enter Form 1 and will be entered in the same form if they have the exit criteria. If they do not have the exit criteria, they will be transferred to Form 2. Setting and conduct: After arranging patients in the three groups and taking written consent for entering to the research, pre-test is carried out and after that, both groups will be treated. Intervention group 1: Exposure and response prevention therapy that will be delivered through 12 sessions. Each session will take 45 minutes and will be held once a week. The patients will be treated by sertraline (50-200 mg/d) by the psychiatrist at the same time prescribed for 12 weeks. Intervention group 2: Acceptance and Commitment therapy that will be delivered through 12 sessions. Each session will take 45 minutes and will be held once a week. The patients will be treated by sertraline (50-200 mg/d) by the psychiatrist at the same time prescribed for 12 weeks. Control group: The patients in this group will receive one sertraline tablet (50-200 mg/d) under the supervision of psychiatrist for 12 weeks, then post-test will bw carried out at the end of therapy and 3 months later after the end of the therapy. Inclusion criteria: age between 18 and 60 years old; minimum level of the third grade at primary school; satisfaction with the company in the research; diagnosis OCD according to DSM5 criteria; receiveing the drug under the supervision of a psychiatrist; earn score 16 and over at Yale-Brown Obsessive Scale. Exclusion criteria: having severe personality disorder; psychotic symptoms (hallucination, delusions); having a physical illness; intellectual disability; Substance abuse. Intervention: Intervention included two groups of exposure and response prevention and acceptance and commitment therapy. Main outcome measures: Primary outcome measures will be OCD signs and symptoms. Secondary outcome measures will be subjective distress; obsessive rituals; control unwanted thoughts.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081335675N1
Registration date:2017-11-02, 1396/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-02, 1396/08/11
Registrant information
Name
Mojgan Salavati
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3346 2102
Email address
m.salavati@hum.uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kurdistan University of Medical Sciences and University of kurdistan.
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of exposure and response prevention method and acceptance and commitment therapy on recovery of patients with obsessive-compulsive disorder receiving sertraline.
Public title
Comparison of psychological and therapeutic treatment on obsessive-compulsive disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 60 years old; minimum level of the third grade primary school; satisfaction with the company in the research; diagnosis OCD according to DSM5 criteria; receive the drug under the supervision of a psychiatrist; getting score 16 and over in Yale-Brown Obsessive Scale. Exclusion criteria: having severe personality disorder; psychotic symptoms (hallucination, delusions); having a physical illness; intellectual disability; Substance abuse.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation based on block redundancy is carried out on 15 individuals per block and three blocks.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Postal code
66141-18665
Approval date
2017-07-10, 1396/04/19
Ethics committee reference number
IR.MUK.REC.1396/77
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsessive-compulsive symptoms
Timepoint
Before the intervention,after the intervention and 3 months after intervention
Method of measurement
The Yale Brown Obsessive-Compulsive Scale (Y-BOCS)
Secondary outcomes
1
Description
Subjective distress
Timepoint
Before the intervention, after the intervention and 3 months after intervention
Method of measurement
Subjective Unit Distress(SUD)
2
Description
Obsessive rituals
Timepoint
Before the intervention, after the intervention and 3 months after intervention
Method of measurement
Stop Signal Questionnaire (SSQ)
3
Description
Control unwanted thoughts
Timepoint
Before the intervention, after the intervention and 3 months after intervention
Method of measurement
Thought Control Questionnaire (TCQ)
Intervention groups
1
Description
Intervention group 1: Exposure and response prevention therapy that will be delivered through 12 sessions. Each session will take 45 minutes and will be held once a week. The patients will be treated by sertraline (50-200 mg/d) by the psychiatrist at the same time prescribed for 12 weeks.
Category
Behavior
2
Description
Intervention group 2: Acceptance and Commitment therapy that will be delivered through 12 sessions. Each session will take 45 minutes and will be held once a week. The patients will be treated by sertraline (50-200 mg/d) by the psychiatrist at the same time prescribed for 12 weeks.
Category
Behavior
3
Description
Control group: The patients in this group will receive one sertraline tablet (50-200 mg/d) under the supervision of psychiatrist for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Family Psychiatry Clinic
Full name of responsible person
Dr Asrin Seyydoshohadayi
Street address
Family Psychiatry Clinic, Adab Street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
Dr Farzin Rezaei
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
University of Kurdistan
Full name of responsible person
Dr Mehdi Zemestani
Street address
University of Kurdistan, Pasdaran Blvd
City
Sanandaj
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Kurdistan
Proportion provided by this source
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
University of Kurdistan
Full name of responsible person
Mojgan Salavati
Position
Master student
Other areas of specialty/work
Street address
University of Kurdistan، Pasdaran Blvd
City
Sanandaj
Postal code
66177-15175
Phone
+98 87 3346 2102
Fax
Email
mojgan.salavaty@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Mehdi Zemestani
Position
PhD in Psychology
Other areas of specialty/work
Street address
University of Kurdistan, Pasdaran Blvd
City
Sanandag
Postal code
66177-15175
Phone
+98 8709124374452
Fax
Email
m.zemestan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Kurdestan
Full name of responsible person
Mojgan Salavati
Position
Master student
Other areas of specialty/work
Street address
University of Kurdestan, Pasdaran Blvd
City
Sanandaj
Postal code
66177-15175
Phone
+98 87 3346 2102
Fax
Email
mojgan.salavaty@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)