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Cognitive Behavior Therapy Among Patients With Major Depressive Disorder-Multiple Episodes.

NCT ID: NCT07300527

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-08-31

Brief Summary

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The main purpose of this study to teach the patients how to manage their depression, generalized Anxiety symptoms, mental health seeking attitude, motivation and attitude toward changing health, to improve the quality of life, and meta memory and meta cognitive functioning after using Adapted CBT. Enhance emotional regulation by helping patients identify and modify maladaptive emotional responses, thereby reducing emotional reactivity and promoting healthier coping strategies. Strengthen relapse prevention skills by equipping patients with long-term cognitive and behavioral techniques to recognize early warning signs and apply learned strategies proactively to prevent future episodes. This research would be helpful for patients etc.

Detailed Description

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In this experimental study, 120 patients will be screened for eligibility from various government and private hospitals. Participants meeting the DSM-5-TR criteria for Major Depressive Disorder (multiple episodes) will be considered. Eighty eligible participants will be randomly assigned to the experimental group (n = 40) and control group (n = 40). Participants aged 18-50 years will be included. Following approval from the university and formal permissions from hospitals and patients, all ethical guidelines will be strictly observed. Eligible participants will be selected based on the inclusion criteria. The CBT group will receive two sessions per week, gradually reduced over time, with each session lasting 45-60 minutes. Pre- and post-assessments will be conducted using standardized measures to evaluate changes in depression severity and related psychological variables.

Expected outcome: The intervention is expected to significantly reduce symptoms of depression and anxiety among participants. Improvements are anticipated in help-seeking attitudes, motivation toward health behavior change, and overall quality of life. CBT is also expected to enhance meta-memory and meta-cognitive functioning. These outcomes will support the effectiveness of CBT in treating patients with recurrent MDD.

Conditions

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Patients With Major Depressive Disorder

Keywords

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patient health questionnaire, mental help seeking attitude motivational attitude toward changing health digit span GAD Brief Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial design would be used in this study. It would be two arm study and there would be two groups an experimental and wait-list control group. Experimental group will receive intervention and control group will take treatment as usual. In this research, parallel group design would be used. We will give treatment to all participants in a parallel way. Allocation ratio and framework would be equivalence i.e., treatment group and control group would be equal number of participants. In order to collect the sample for the desired study, purposive sampling technique would be used. Patient's age range would be between 18 to 50 years. Participant would be divided into two groups. In group one, the diagnosed patients of MDD who will receive Cognitive behavior therapy would be taken 8-10 sessions. The control group will receive treatment as usual. Each of the group will be comprised of n= 40.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1st Arm (1- Experimental)

Patients will receive cognitive behavioral Therapy

Group Type EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

This involves 10 sessions, 2 sessions per week will be conduct, session 1 ( psychoeducation about the problem, second will be cognitive Distortions, thirdly, automatic Thoughts , ABC Worksheet (Antecedent-Belief-Consequence), (Greenberger \& Padesky, 2016) Daily Thought Monitoring Sheet, "Catch It - Check It - Change It" model. fourthly, Core beliefs And Dysfunctional Schemas, Downward Arrow Technique (Beck, 2011) Flashcards for Positive Beliefs, "What does that say about me?" , REFRAMING (Beck, 2011), fifth, Behavioral Activation, Increase engagement in pleasurable and meaningful activities. sixth, Memory and concentration, Enhance mindfulness and address cognitive memory concerns. To help patient focus on present moment. seventh, stress management Training, eighthly, problem solving skills, Relationship management skills, lastly, relapse Prevention, review skills, plan for future, reinforce independence.

each session have specific goals and outcomes.

treatment as usual (TAU) (Control Group)

Intervention Type DRUG

Participants in this arm will receive Treatment as Usual (TAU) provided by the hospital, which may include routine psychiatric care, medication management, and supportive counseling as prescribed by the treating psychiatrist. No structured psychotherapy sessions, such as CBT, will be administered during the study period. This group will serve as the control condition to compare the effects of Cognitive Behavioral Therapy (CBT) on depressive symptoms and related psychological outcomes. Standard care procedures will continue throughout the study, and participants will be assessed at the same pre- and post-intervention time points as the experimental group.

2nd Arm (Waitlist Control Condition)

This group will receive treatment as usual

Group Type ACTIVE_COMPARATOR

treatment as usual (TAU) (Control Group)

Intervention Type DRUG

Participants in this arm will receive Treatment as Usual (TAU) provided by the hospital, which may include routine psychiatric care, medication management, and supportive counseling as prescribed by the treating psychiatrist. No structured psychotherapy sessions, such as CBT, will be administered during the study period. This group will serve as the control condition to compare the effects of Cognitive Behavioral Therapy (CBT) on depressive symptoms and related psychological outcomes. Standard care procedures will continue throughout the study, and participants will be assessed at the same pre- and post-intervention time points as the experimental group.

Interventions

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Cognitive Behavior Therapy

This involves 10 sessions, 2 sessions per week will be conduct, session 1 ( psychoeducation about the problem, second will be cognitive Distortions, thirdly, automatic Thoughts , ABC Worksheet (Antecedent-Belief-Consequence), (Greenberger \& Padesky, 2016) Daily Thought Monitoring Sheet, "Catch It - Check It - Change It" model. fourthly, Core beliefs And Dysfunctional Schemas, Downward Arrow Technique (Beck, 2011) Flashcards for Positive Beliefs, "What does that say about me?" , REFRAMING (Beck, 2011), fifth, Behavioral Activation, Increase engagement in pleasurable and meaningful activities. sixth, Memory and concentration, Enhance mindfulness and address cognitive memory concerns. To help patient focus on present moment. seventh, stress management Training, eighthly, problem solving skills, Relationship management skills, lastly, relapse Prevention, review skills, plan for future, reinforce independence.

each session have specific goals and outcomes.

Intervention Type BEHAVIORAL

treatment as usual (TAU) (Control Group)

Participants in this arm will receive Treatment as Usual (TAU) provided by the hospital, which may include routine psychiatric care, medication management, and supportive counseling as prescribed by the treating psychiatrist. No structured psychotherapy sessions, such as CBT, will be administered during the study period. This group will serve as the control condition to compare the effects of Cognitive Behavioral Therapy (CBT) on depressive symptoms and related psychological outcomes. Standard care procedures will continue throughout the study, and participants will be assessed at the same pre- and post-intervention time points as the experimental group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age range: 18-50 years No physical, psychiatric, or psychological conditions. patients who meet multiple Episodes. who meet DSM 5 TR Major Depressive Disorder Criteria. patients who meet moderate severity at patient health questionnaire scale .

Exclusion Criteria

* age range: below 18 and above 50 years. presence of any physical, psychiatric, or psychological conditions. who do not meet DSM 5 TR Major Depressive Disorder Criteria. range at patient health questionnaire scale is mild , minimal or severe or moderately severe.
Minimum Eligible Age

18 Weeks

Maximum Eligible Age

50 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government College University Faisalabad

OTHER

Sponsor Role lead

Responsible Party

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Qasir Abbas

Assistant Professor - Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qasir Abbas Dr, PhD Clinical Psychology

Role: PRINCIPAL_INVESTIGATOR

Government College University Faisalabad

Locations

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Government College University Faisalabad

Faisalabad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Qasir Abbas Dr, PhD Clinical Psychology

Role: CONTACT

Phone: 923337683133

Email: [email protected]

Ayesha Mirza Ms, MS Clinical Psychology

Role: CONTACT

Phone: 923211743095

Email: [email protected]

Facility Contacts

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Qasir Abbas

Role: primary

Other Identifiers

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GCUF_PsychThesisTrial

Identifier Type: -

Identifier Source: org_study_id