- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02534948
Feasibility Study of Mindfulness and Acceptance Based Group Therapy for Social Anxiety (MABT)
August 8, 2023 updated by: Zohra Batool, Bahria University
Feasibility Study of Mindfulness and Acceptance Based Group Therapy for Females With Social Anxiety
Anxiety and depressive disorders are common in all regions of the world.
Anxiety disorders are considered as third major psychological issue in Pakistan (Panhwer, 2014).
Objective of the present study is to see the feasibility and effectiveness of social anxiety in females with the help of mindfulness and acceptance based therapy.
It is hypothesized that women in the intervention group will have significantly reduced anxiety as compared to the women in the control group.
A total of 60 females in the age range of 18 to 28 ages will be selected from Institute of professional psychology and private clinics from Karachi city.
The participants will be recruited through the administration of Mini-Social Phobia Inventory (SPIN-mini).
The participants will be randomly divided in interventions and control group and will receive the intervention of ten sessions of group therapy of MABT plan.
Assessment will be conducted at the baseline and at the end of the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Anxiety and depressive disorders are becoming the major psychological issue in Pakistan due to several circumstances.
Social anxiety is one the prominent symbol for psychological disturbance observed in young generation.
Since, other therapeutic approaches for social anxiety have not shown significant benefit regarding improvement of symptoms recovery and to avoid relapse of the symptoms, further researches needed to focus on improving post-functioning recovery.
The uses of mindfulness and acceptance base group therapy manual for social anxiety has shown significantly reduce symptoms of social anxiety after the therapy in other regions of the world.
In this regard the present study will help to enhance the variety of treatment plan and to evaluate the effectiveness of mindfulness in this subject.
Therefore, objective of the present study is to see the feasibility and effectiveness of social anxiety in females with the help of mindfulness and acceptance based therapy.
In this regard hypothesis is designed as; women in the intervention group will have significantly reduced anxiety as compared to the women in the control group .
A total of 60 females in the age range of 18 to 28 ages will be recruited from Institute of professional psychology .
The participants will be recruited through the administration of Mini-Social Phobia Inventory (SPIN-mini).
Total of 32 participants will be randomly divided in interventions and control group will receive the intervention of ten sessions of group therapy of MABT plan.
The manual group intervention will be provided as per the second edition of Mindfulness and Acceptance-Based Group Therapy for Social Anxiety Disorder: A Treatment Manual developed by Fleming, and Kocovski (2014).
The intervention will consist of 10 group therapy sessions.
Each session will be conducted in 120 minutes.
It includes therapist manual, client handouts, and is written to be used in conjunction with The Mindfulness and Acceptance Workbook for Social Anxiety and Shyness.
The treatment manual can be easily adapted for individual therapy clients.At the end scores of re-administration of the questionnaire will help to assess the outcomes of the study.
Results of this intervention study will be analysed through quantities measures.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Institute of Professional Psychology, Bahria University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Individuals who score 6 or above on social phobia inventory.
- Participants who understand Basic English and Urdu language.
Exclusion Criteria:
- History of severe mental illness or organic brain damage i.e. schizophrenia and related disorders; especially in the last few years. Any related medication taken or medication being taken now in this regard.
- Active or recent physical addiction to alcohol or drugs.
- Individuals who were diagnosed with Post-traumatic stress disorder.
- Individuals with severe social anxiety which would make attending very stressful.
- Individuals with already receiving psychological therapy or any other psychiatric treatment.
- Individuals who are involved in persistent self-harm or suicide risk requiring management.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness and acceptance group therapy
The intervention group will consist of female participants who will be provided MABT in a group.The intervention will consist of 10 group therapy sessions.
Each session will be conducted for 120 minutes.
|
The manual group intervention will be provided as per the second edition of Mindfulness and Acceptance-Based Group Therapy for Social Anxiety Disorder: A Treatment Manual developed by Fleming, and Kocovski (2014).
The intervention will consist of 10 group therapy sessions.
Each session will be conducted in 120 minutes.
It includes therapist manual, client handouts, and is written to be used in conjunction with The Mindfulness and Acceptance Workbook for Social Anxiety and Shyness.
The treatment manual can be easily adapted for individual therapy clients.
|
|
No Intervention: wait list control group
The control group will be the waiting list control group will receive no interventions in the first stage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini Social Phobia inventory
Time Frame: three months
|
It is a brief screening assessment for generalized social anxiety disorder comprised on 3-item self-rated scale.
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Zainab F. Zadeh, Phd, Institute of Professional Psychology, Bahria University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
August 26, 2015
First Submitted That Met QC Criteria
August 27, 2015
First Posted (Estimated)
August 28, 2015
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MABT001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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