NCT02534948

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

August 26, 2015

Last Update Submit

August 8, 2023

Conditions

Keywords

mindfulnessMABTsocial anxietymindfulness and acceptancegroup therapy

Outcome Measures

Primary Outcomes (1)

  • Mini Social Phobia inventory

    It is a brief screening assessment for generalized social anxiety disorder comprised on 3-item self-rated scale.

    three months

Study Arms (2)

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.

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.

Interventions

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.

Mindfulness and acceptance group therapy

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who score 6 or above on social phobia inventory.
  • Participants who understand Basic English and Urdu language.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Professional Psychology, Bahria University

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Zainab F. Zadeh, Phd

    Institute of Professional Psychology, Bahria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M. Phil Candidate

Study Record Dates

First Submitted

August 26, 2015

First Posted

August 28, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations