UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000055787
Receipt number R000063755
Scientific Title THE EFFICACY OF DIALECTICAL BEHAVIOR THERAPY ON DEPRESSION AND ANXIETY AMONG COLLEGE STUDENTS: A RANDOMIZED CONTROLLED TRIAL
Date of disclosure of the study information 2024/10/08
Last modified on 2024/10/08 23:50:33

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Basic information

Public title

THE EFFICACY OF DIALECTICAL BEHAVIOR THERAPY ON DEPRESSION AND ANXIETY AMONG COLLEGE STUDENTS: AN INTERVENTION BASED STUDY

Acronym

Dialectical behavioral therapy, Hamilton Anxiety rating scale, Hamilton Depression rating scale, college students, Module of Dialectical behavioral therapy.

Scientific Title

THE EFFICACY OF DIALECTICAL BEHAVIOR THERAPY ON DEPRESSION AND ANXIETY AMONG COLLEGE STUDENTS: A RANDOMIZED CONTROLLED TRIAL

Scientific Title:Acronym

Dialectical behavioral therapy, Hamilton Anxiety rating scale, Hamilton Depression rating scale, college students, Module of Dialectical behavioral therapy.

Region

Asia(except Japan)


Condition

Condition

THE EFFICACY OF DIALECTICAL BEHAVIOR THERAPY ON DEPRESSION AND ANXIETY AMONG COLLEGE STUDENTS

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of Dialectical Behavior Therapy in giving depression and anxiety in college students.
To examine the efficacy of Dialectical Behavior Therapy in improving participants' overall well-being and distress tolerance.
To examine the efficacy of Dialectical Behavior Therapy in improving emotional control in college students.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

It helped to enhance the efficacy of Dialectical Behavior Therapy on Depression and Anxiety among college students. Depression Anxiety Stress Scale for Screening and Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale used for intervention at Pre Post and follow up level

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Other

Interventions/Control_1

Experimental group received Intervention about Efficacy of Dialectical Behavior Therapy. This group received education about Dialectical Behavior Therapy on Depression and Anxiety in 6-7 sessions. Each session was 40-45 minutes.

Interventions/Control_2

Control group act as a waitlist

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

16 years-old <=

Age-upper limit

21 years-old >=

Gender

Male and Female

Key inclusion criteria

After screening participant who showed mild to moderate close of Depression and Anxiety are included. Both male and female students are involved. Age range is between 16-21.

Key exclusion criteria

All those students who did not complete the assessment tool was excluded from the sample. Any physical condition that would be impede participation in the interventional programmed.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Dr Urooj
Middle name
Last name Sadiq

Organization

Department of Professional Psychology Bahria University, Lahore

Division name

Lahore, Punjab, Pakistan

Zip code

54782

Address

47-C Civic Center, Johar Town. Block D, Lahore

TEL

0300-2661136

Email

uroojsadiq_icp@yahoo.com


Public contact

Name of contact person

1st name Dr Urooj
Middle name
Last name Sadiq

Organization

Department of Professional Psychology Bahria University, Lahore

Division name

Lahore, Punjab, Pakistan

Zip code

54782

Address

47-C Civic Center, Johar Town. Block D, Lahore

TEL

0300-2661136

Homepage URL


Email

uroojsadiq_icp@yahoo.com


Sponsor or person

Institute

Bahria University Lahore Campus

Institute

Department

Personal name



Funding Source

Organization

Non-funded research

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Professional Psychology, Bahria University

Address

47-C Civic Center, Johar Town. Block D, Lahore

Tel

04299233408

Email

Khawer.bulc@bahria.edu.pk


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2024 Year 10 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2024 Year 03 Month 09 Day

Date of IRB


Anticipated trial start date

2024 Year 04 Month 12 Day

Last follow-up date

2024 Year 08 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 10 Month 08 Day

Last modified on

2024 Year 10 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063755