Effectiveness of Interpersonal Psychotherapy in Patients with Social Anxiety Disorder with Comorbid Depressive Symptoms: Symptoms Reduction, Interpersonal Problems and Quality of Life Improvement, and Change of Therapeutic Mediators.
Effectiveness of interpersonal psychotherapy on symptoms reduction, improvement of function, change of therapeutic mediators and quality of life in patients with social anxiety disorder with comorbid Depressive Symptoms
Design
This is a Randomized Controlled Trial (RCT) in which randomization software will be used to assign 20 patients to intervention and control groups randomly.
Settings and conduct
This study will be conducted in the psychology clinic of Taleghani hospital. Having done diagnostic interview, patients suffering from social anxiety disorder with comorbid depressive symptoms will be assigned to the intervention or control group randomly. Prior to the treatment and in pre-test, baseline assessments will be conducted. Then, patients in the treatment group will participate in weekly 12-session individual interpersonal psychotherapy, whereas there will be no intervention to the control group. Participants in the treatment group will complete the whole measures in session 3, 6, 9, and 12 and patients in the control group will answer these measures again only after 12 weeks. Finally, all participants will complete measures in a 2-month follow-up. It is worth mentioning that in order to comply with the ethical principles, all participants in the control group will also receive interpersonal psychotherapy after follow-up.
Participants/Inclusion and exclusion criteria
Participants: Patients with social anxiety disorder with comorbid depressive symptoms
Include Criteria: being Diagnosed with social anxiety disorder with comorbid depressive symptoms; being aged 15-50 years' old; being educated at least at middle school level; participants should not have received any psychological interventions within the past 3 years or any pharmacotherapy at least one month before the baseline assessment until the end of follow-up; not being diagnosed with psychiatric disorders which necessitate urgent treatments and having motivation and satisfaction to participate in the research.
Exclude Criteria: primary and main diagnosis of mood disorders or other anxiety disorders; presence of psychiatric disorders requiring urgent treatments; meeting full criteria of personality disorders, except those of avoidance personality disorder; suicidal ideation or extreme thinking about self-harm; having IQ below the normal range; missing more than 3 sessions of psychotherapy and participation in another treatment plan simultaneously.
Intervention groups
Intervention group: A group of patients who will receive a 12-session individual interpersonal psychotherapy.
Control group: A group of patients who will not receive any kinds of psychotherapy within the period when participants in the intervention group are getting interpersonal psychotherapy.
Main outcome variables
social anxiety; fear on negative evaluation; depression; interpersonal difficulties; quality of life; social support; interpersonal stress; emotion regulation strategies; difficulties in emotion regulation; interpersonal skills.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161110030822N1
Registration date:2018-02-24, 1396/12/05
Registration timing:prospective
Last update:2018-02-24, 1396/12/05
Update count:0
Registration date
2018-02-24, 1396/12/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 4023
Email address
hamid.amiri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Interpersonal Psychotherapy in Patients with Social Anxiety Disorder with Comorbid Depressive Symptoms: Symptoms Reduction, Interpersonal Problems and Quality of Life Improvement, and Change of Therapeutic Mediators.
Public title
Effectiveness of Interpersonal Psychotherapy in Patients with Social Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum education should be middle school grade.
Participants should not have received psychological interventions over the past 3 years or drug treatment at least one month before the baseline measurement stage until the end of the follow-up.
The absence of psychiatric disorders necessitates urgent treatments such as substance use disorders, alcohol use disorder and psychotic disorders.
Having the motivation and satisfaction to participate in the research.
Diagnosis of social anxiety disorder with comorbid depressive symptoms
Exclusion criteria:
Primary diagnosis of mood disorders and other anxiety disorders
The presence of psychiatric disorders requiring immediate treatment such as substance use disorders, alcohol use disorder and psychotic disorders.
Having complete criteria for personality disorders, except for avoidance personality disorder
Suicide Ideation or extreme thinking about self harm
IQ below the normal range
Missing more than 3 sessions of psychotherapy
participate simultaneously in another treatment plan
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the sample group and explaining the research objectives and methods and before obtaining informed consent, patients will be randomized using randomized software in two groups of interpersonal psychotherapy and control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up
Method of measurement
Social Phobia Inventory and Brief Fear of Negative Evaluation Scale
2
Description
Beck Depression Inventory-II Score
Timepoint
Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up
Method of measurement
Beck Depression Inventory-II
3
Description
Interpersonal Problems
Timepoint
Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up
Method of measurement
Inventory of Interpersonal Problems
4
Description
Quality of Life
Timepoint
Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up
Method of measurement
The World Health Organization Quality of Life
5
Description
Social Support
Timepoint
Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up
Method of measurement
Social Support Appraisals Scale
6
Description
Interpersonal Stress
Timepoint
Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up
Method of measurement
Life Distress Inventory and a researcher-made questionnaire
7
Description
Emotion Regulation
Timepoint
Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up
Method of measurement
Emotion Regulation Questionnaire and Difficulties in Emotion Regulation Scale
8
Description
Interpersonal Skills
Timepoint
Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up
Method of measurement
Interpersonal Communication Skills Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Patients with social anxiety disorder participating in 12 weekly and individually sessions and receive interpersonal psychotherapy. Control Group: Patients with social anxiety disorder who are in the waiting list and do not receive intervention.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The title of the data will be ‘’the effectiveness of interpersonal psychotherapy on social anxiety disorder’’. All data can be shared after making participants anonymous.
When the data will become available and for how long
Six months after publishing results, everything will be accessible.
To whom data/document is available
The data from this research will be accessible only to mental health researchers and those who are working in academic and scientific institutions.
Under which criteria data/document could be used
With respect to ethical considerations, the data from this research can be used for other research purposes. It is also possible to conduct any statistical analyses. All these processes require correspondence and coordination.
From where data/document is obtainable
All applicants can contact Mr. Hamid Amiri through one of the following ways:
1. Email address: hamid.amiri@sbmu.ac.ir
2. Phone number: +98 21 23031548
3. Adress: Department of Clinical Psychology, Taleghani Hospital, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
What processes are involved for a request to access data/document
Within 10 working days after correspondence or a phone call, your request will be answered and the data will be sent to a valid email submitted by the applicant.