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Trial registered on ANZCTR


Registration number
ACTRN12623001220651p
Ethics application status
Not yet submitted
Date submitted
20/06/2023
Date registered
27/11/2023
Date last updated
27/11/2023
Date data sharing statement initially provided
27/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Behavioral Therapy Intervention on Mental Wellbeing among Elderly Population
Scientific title
Cognitive Behavioral Therapy (CBT) Intervention on Mental Wellbeing among Elderly Population: A Multi-Method Study Design
Secondary ID [1] 309928 0
Nil
Universal Trial Number (UTN)
Trial acronym
CBT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 330403 0
Resilience 330405 0
Mental Wellbeing 330406 0
Condition category
Condition code
Mental Health 327246 327246 0 0
Depression
Public Health 327247 327247 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioral Therapy (CBT) intervention based on the Roy Adaptation Model’s concepts such as physiological, self-concept, interdependence, and role functions will be provided to evaluate the effectiveness on mental well-being (depression, quality of life, and resilience) among older adults. The model has considered is a grand nursing theory that explains the relationship between mental problems with well-being based on theoretical perspectives (Butts & Rich, 2021).

The intervention aims to measure the effect on mental well-being such as thought processes, behavior, emotions, physical symptoms, functional capabilities, and socialization. Moreover, the content that will be included in the intervention is handling life situations, emotional regulations, hopefulness, managing symptoms, self-control, problem-solving strategies, and promoting positive and constructive thoughts and behaviors. This trial aims to compare the study outcome (mental well-being) through CBT intervention between the intervention and control groups. The intervention group will receive six weeks of CBT along with the treatment as usual. However, controlled group will receive treatment as usual only.

The primary investigator with the collaboration of a psychologist will provide the intervention. The primary investigator is a Ph.D. Scholar and experienced mental health nurse with plenty of clinical and teaching experience of more than 12 years. The PI has experience in conducting various mental health seminars and sessions for both the general public and vulnerable populations. Moreover, psychologists will add information, plan, and guide the intervention for accurate and efficient delivery of content to the population.

Six weeks of CBT intervention of six sessions will be provided to evaluate the effects on the mental well-being of older adults. For the intervention, there will be one session per week of 90 minutes, allowing the study participants to come together on one platform. The session will be taken face to face in a group of 6-8 people in the seminar room of the study setting.
Attendance will be marked in each session who are receiving the intervention. In addition, for adherence to the intervention, telephonic conversation will be performed regularly with the participants and attendance checklist will be provided and monitoring will be performed by primary investigator himself.
Intervention code [1] 326356 0
Rehabilitation
Intervention code [2] 326357 0
Lifestyle
Comparator / control treatment
The control group will receive treatment as usual prescribed by the physician. The treatment as usual means based upon the participants health condition or symptoms receiving any type medical drugs/service prescribed by the physician or doctor.
Control group
Active

Outcomes
Primary outcome [1] 335127 0
Geriatric Depression Scale Score, a score greater than 5 suggests depression
Timepoint [1] 335127 0
0 week (pre-intervention phase- before the start of intervention)
6 weeks (post-intervention phase- at the end of six weeks CBT intervention)
12 weeks (follow-up phase - six weeks after completion of intervention means six weeks
after post-intervention phase)
Primary outcome [2] 335128 0
World Health Organization Quality of life Tool Score, a high score indicate a good quality of life
Timepoint [2] 335128 0
0 week (pre-intervention phase- before the start of intervention)
6 weeks (post-intervention phase- at the end of six weeks CBT intervention)
12 weeks (follow-up phase - six weeks after completion of intervention means six weeks
after post-intervention phase)
Primary outcome [3] 335129 0
Resilience Scale (RS-14), mean resilience score and scores below 65 indicate low resilience
Timepoint [3] 335129 0
0 week (pre-intervention phase- before the start of intervention)
6 weeks (post-intervention phase- at the end of six weeks CBT intervention)
12 weeks (follow-up phase - six weeks after completion of intervention means six weeks
after post-intervention phase)
Secondary outcome [1] 423177 0
Nil
Timepoint [1] 423177 0
Nil

Eligibility
Key inclusion criteria
- Early older adults
- Newly diagnosed cases of depression less than or equal to one year.
- Ability to speak and read Urdu / English language
- Willing to participate in the study and giving consent to participate in the study
Minimum age
60 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Individuals with hypomanic/manic episodes, cognitive impairment, or active homicidal/suicidal ideation
- Individuals with severe alcoholism or substance abuse disorder
- Being involved in any other intervention
- Individuals with communication deficits make understanding and discussion impossible

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central-randomisation by computers
After determining the study subjects’ eligibility and obtaining signed informed consent. The computer software-generated random allocation will be performed and the participants will be randomly allocated to interventional and control groups from the study setting.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The data will be analyzed at all three measurement points using the Statistical Package of Social Sciences (SPSS) version 26.0. Initially, the data will be checked for normal distribution through the Shapiro–Wilk test as explained by Bluman (2010). For descriptive statistics, means ± standard deviations and proportions (frequency) will be reported for continuous and categorical variables respectively. The difference in the scores of depression, QoL, and resilience will be calculated through Analysis of Variance (ANOVA) and t-test for independent samples. In addition, the association of treatment success rate with independent variables will be estimated by applying a t-test for two independent samples for continuous variables and a Chi-square test of independence for categorical variables. The analysis will be performed at a 95% confidence interval (level of significance of 0.05) and a P-value of less than 5% will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/02/2024
Actual
Date of last participant enrolment
Anticipated
25/03/2024
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
136
Accrual to date
Final
Recruitment outside Australia
Country [1] 25601 0
Pakistan
State/province [1] 25601 0
Sindh

Funding & Sponsors
Funding source category [1] 314108 0
Self funded/Unfunded
Name [1] 314108 0
Santosh Kumar
Country [1] 314108 0
Pakistan
Primary sponsor type
Individual
Name
Santosh Kumar
Address
Aga Khan University, Faculty of Health Sciences, KarachiNational Stadium Road, P.O. Box 3500.Karachi, 74800, Sindh Province, Pakistan
Country
Pakistan
Secondary sponsor category [1] 316027 0
University
Name [1] 316027 0
Aga Khan University
Address [1] 316027 0
Aga Khan University, Faculty of Health Sciences, KarachiNational Stadium Road, P.O. Box 3500.Karachi, 74800, Sindh Province, Pakistan
Country [1] 316027 0
Pakistan

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313250 0
Ethical Review Committee, Aga Khan University
Ethics committee address [1] 313250 0
Ethics committee country [1] 313250 0
Pakistan
Date submitted for ethics approval [1] 313250 0
23/01/2024
Approval date [1] 313250 0
Ethics approval number [1] 313250 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127474 0
Mr Santosh Kumar
Address 127474 0
Aga Khan University, Faculty of Health Sciences, KarachiNational Stadium Road, P.O. Box 3500.Karachi 74800, Sindh Province, Pakistan
Country 127474 0
Pakistan
Phone 127474 0
+923333267825
Fax 127474 0
Email 127474 0
santosh.kumar2@scholar.aku.edu
Contact person for public queries
Name 127475 0
Santosh Kumar
Address 127475 0
Aga Khan University, Faculty of Health Sciences, KarachiNational Stadium Road, P.O. Box 3500.Karachi 74800, Sindh Province, Pakistan
Country 127475 0
Pakistan
Phone 127475 0
+923333267825
Fax 127475 0
Email 127475 0
santosh.kumar2@scholar.aku.edu
Contact person for scientific queries
Name 127476 0
Santosh Kumar
Address 127476 0
Aga Khan University, Faculty of Health Sciences, KarachiNational Stadium Road, P.O. Box 3500.Karachi 74800, Sindh Province, Pakistan
Country 127476 0
Pakistan
Phone 127476 0
+923333267825
Fax 127476 0
Email 127476 0
santosh.kumar2@scholar.aku.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain the participants privacy and confidentiality individual participants data will not be shared. However, research finding and results will be published in recognized and reputable journal.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19483Statistical analysis plan  santosh.kumar2@scholar.aku.edu It can be obtained by email to primary investigato... [More Details]
19484Informed consent form  santosh.kumar2@scholar.aku.edu It can be obtained by email to primary investigato... [More Details]
19485Ethical approval  santosh.kumar2@scholar.aku.edu It can be obtained by email to primary investigato... [More Details]
19746Study protocol  santosh.kumar2@scholar.aku.edu It can be obtained by email to primary investigato... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.