Social AnxietyMABTNCT02534948
Feasibility Study of Mindfulness and Acceptance Based Group Therapy for Social Anxiety
A study testing Mindfulness and acceptance group therapy in people with Social Anxiety, run by Bahria University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 28 years, women only
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Mindfulness and acceptance group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who score 6 or above on social phobia inventory.
- Participants who understand Basic English and Urdu language.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Professional Psychology, Bahria University
Karachi, Sindh
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety
- Being tested
- Mindfulness and acceptance group therapy
- Keywords
- mindfulness, MABT, social anxiety, mindfulness and acceptance, group therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and acceptance group therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness and acceptance group therapy | Experimental | 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. Receives: Behavioral: Mindfulness and acceptance group therapy |
| wait list control group | No intervention | The control group will be the waiting list control group will receive no interventions in the first stage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Social Phobia inventory
It is a brief screening assessment for generalized social anxiety disorder comprised on 3-item self-rated scale.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohra Batool, Bahria University
- Investigators
- Zainab F. Zadeh, Phd, Study director, Institute of Professional Psychology, Bahria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534948
- Sponsor's protocol ID
- MABT001
- Acronym
- MABT
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2015
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Mindfulness and Acceptance Based Group Therapy for Females With Social Anxiety
- ClinicalTrials.gov ID
- NCT02534948
- Acronym / sponsor ID
- MABT / MABT001
- Conditions
- Social Anxiety
- Keywords
- mindfulness, MABT, social anxiety, mindfulness and acceptance, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and acceptance group therapy | Experimental | Behavioral: Mindfulness and acceptance group therapyThe 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. |
| wait list control group | No intervention | –The control group will be the waiting list control group will receive no interventions in the first stage. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individuals who score 6 or above on social phobia inventory.
- Participants who understand Basic English and Urdu language.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and acceptance group therapyThe 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. | Behavioural | Mindfulness and acceptance group therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zainab F. Zadeh, Phd study director
Institute of Professional Psychology, Bahria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and acceptance group therapy in people with Social Anxiety, run by Bahria University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini Social Phobia inventory (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.