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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Mindfulness and acceptance group therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bahria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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