EFFECTIVENESS OF LIVING LIFE TO THE FULL (LLTTF) INTERVENTION FOR REDUCING ANXIETY AND DEPRESSION AMONG ADOLESCENTS: A RANDOMIZED CONTROLLED TRIAL

Last registered on January 17, 2025

Pre-Trial

Trial Information

General Information

Title
EFFECTIVENESS OF LIVING LIFE TO THE FULL (LLTTF) INTERVENTION FOR REDUCING ANXIETY AND DEPRESSION AMONG ADOLESCENTS: A RANDOMIZED CONTROLLED TRIAL
RCT ID
AEARCTR-0015218
Initial registration date
January 17, 2025

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
January 17, 2025, 7:50 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation

Other Primary Investigator(s)

PI Affiliation
National University of Medical Sciences

Additional Trial Information

Status
On going
Start date
2024-12-27
End date
2025-01-30
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Anxiety and depression are significant mental health challenges among adolescents in Pakistan. This study aims to evaluate the effectiveness of the "Living Life to the Full" (LLTTF) program in addressing these issues among adolescents aged 14-16 years. The LLTTF program incorporates techniques such as challenging negative thoughts, scheduling positive activities, and solving problems to help improve mental well-being. Participants will be randomly divided into two groups: the intervention group, which will receive the LLTTF program, and the control group, which will continue with usual care. Data on anxiety (GAD-7), depression (PHQ-9), self-esteem (RSES), and functional impairment (WSAS) will be collected at three points: baseline, pre-intervention, and post-intervention. The intervention will consist of four weekly sessions, where participants will use planners and worksheets to practice LLTTF strategies. Statistical analysis will be conducted to evaluate the program's effectiveness in reducing symptoms and improving daily functioning. This research aims to provide valuable insights into improving mental health care for adolescents in Punjab and promoting better mental health outcomes in this population.

External Link(s)

Registration Citation

Citation
Rizwan, Muhammad and Omaima Zia. 2025. "EFFECTIVENESS OF LIVING LIFE TO THE FULL (LLTTF) INTERVENTION FOR REDUCING ANXIETY AND DEPRESSION AMONG ADOLESCENTS: A RANDOMIZED CONTROLLED TRIAL." AEA RCT Registry. January 17. https://doi.org/10.1257/rct.15218-1.0
Experimental Details

Interventions

Intervention(s)
The intervention involves implementing the "Living Life to the Full" (LLTTF) program over four weeks, targeting adolescents aged 14-16 years experiencing anxiety and depression. Participants in the intervention group will attend one session per week, focusing on LLTTF techniques such as challenging negative thoughts, scheduling positive activities, and solving everyday problems. Each session will be supported by worksheets and planners to reinforce learning and encourage practice outside the sessions.
Intervention (Hidden)
The intervention is a structured, four-week program based on the "Living Life to the Full" (LLTTF) framework, aimed at helping adolescents aged 14-16 years manage anxiety and depression. It consists of one 1.5-hour session each week, where participants engage in activities designed to build practical skills for mental health management. The program focuses on key LLTTF techniques, including challenging negative thoughts, scheduling positive activities, and developing problem-solving skills. Participants are encouraged to identify and reframe negative thinking, engage in meaningful activities to improve mood, and break down problems into manageable steps. Each session is complemented with worksheets and planners that help reinforce these skills outside of sessions. Adolescents actively participate in group discussions, complete exercises, and are assigned weekly homework to practice the techniques learned.
Intervention Start Date
2024-12-30
Intervention End Date
2025-01-27

Primary Outcomes

Primary Outcomes (end points)

The primary outcomes of the intervention will focus on the reduction of anxiety and depressive symptoms among participants. These outcomes will be measured using validated tools. Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7), which helps evaluate the severity of anxiety symptoms in adolescents. Depression will be measured using the Patient Health Questionnaire (PHQ-9), which assesses the intensity of depressive symptoms.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
The secondary outcomes of the intervention will focus on functional impairment and self-esteem. Functional impairment will be assessed using the Work and Social Adjustment Scale (WSAS), which measures how anxiety and depression impact participants' ability to perform daily tasks, such as work, school, social interactions, and home responsibilities. Self-esteem will be evaluated with the Rosenberg Self-Esteem Scale (RSES), which assesses participants' perceptions of their self-worth and overall self-confidence.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design

The experimental design for my research is a randomized controlled trial (RCT), where adolescents are randomly assigned to either an intervention group receiving the LLTTF program or a control group.
Experimental Design Details
Randomization Method
In study, randomization was done using the chit technique, where each participant drew a chit from a container, with each chit corresponding to either the experimental group or the control group. This method ensured a simple, unbiased random assignment of participants.







Randomization Unit
The unit of randomization was individuals, where each adolescent participant was randomly assigned to either the intervention group (LLTTF program) or the control group using the chit technique. There was no additional level of randomization.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
4 schools of Sialkot, Punjab
Sample size: planned number of observations
80 students
Sample size (or number of clusters) by treatment arms
40 students in control group 40 in experimental group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials