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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 50 weeks
• All sexes
• Healthy volunteers accepted
• Child

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Cognitive Behavior Therapy for Dysfunctional Cognitive and Behavioral Patterns and Functional Outcomes Among Patients With Major Depressive Disorder-Multiples Episodes: Randomized Control Trial.

Conditions

Patients With Major Depressive Disorder

Being tested

Cognitive Behavior Therapy, treatment as usual (TAU) (Control Group)

Keywords

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Cognitive Behavior TherapyBehavioural

  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)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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Patient Health Questionnaire PHQ-9 (Kroenke, and colleagues, 1999)

   Kroenke, and colleagues (1999) from Columbia University developed Patient Health Questionnaire. In the current study Patient Health Questionnaire 9 item questionnaire translated by (Ahmad, Hussain, Akhtar \& Shah, 2018). Each item could be responded to using a 4-point Not at all = 0; several days = 1; More than half the days = 2; nearly every day = 3. The PHQ-9 has 9 items, each of which is scored 0,1,2,3, leading to a maximum score of 27. The total scores of 5, 10, 15 and 20 are taken as mild, moderate, moderately severe and severe in terms of the questioner's depressive illness. Cronbach's alpha for PHQ-9 was 0.91. The reliability was further supported by split-half reliability for PHQ-9; part 1 (r = 0.86), part 2 (r = 0.84) and correlation between two halves (r = 0.77), Spearman Brown coefficient was 0.87, and Guttmann split-half coefficient was 0.8.

   Measured: at pre-Assessment, after 5 weeks at post-Assessment

2. Generalized Anxiety Disorder 7-item scale (GAD-7)

   The Generalized Anxiety Disorder 7-item scale (GAD-7) is a widely used self-report screening tool designed to assess the severity of generalized anxiety symptoms. Developed by Spitzer et al. (2006), the scale consists of 7 items, each rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate greater levels of anxiety. The GAD-7 has demonstrated high internal consistency, with a Cronbach's alpha of 0.92, and test-retest reliability of 0.83, making it a reliable instrument for both clinical and research use. In the present study, the GAD-7 will be used to measure anxiety symptoms before and after the intervention, allowing evaluation of the impact of Adapted CBT on comorbid anxiety in patients with Major Depressive Disorder.

   Measured: at Pre-Assessment, after 5 weeks at post-Assessment

3. WHOQOL BREF Scale (WHO; Skevington, Lotfy &Connell, 2004).

   WHO developed WHOQOL BREF scale. In the current study WHOQOL Brief scale translated by (Ahmad, Hussain, Akhtar \& Shah, 2018). The WHOQOL-Brief, still in field trials, is a subset of 26 items taken from the WHOQOL-100. The same steps for the scoring WHOQOL-100 should be followed to achieve scores for the Brief. The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. Three items of the Brief must be reversed before scoring.

   Measured: at pre-assessment, after 5 weeks at post-assessment

4. Mental Help-Seeking Attitudes Scale (MHSAS),

   The Mental Help-Seeking Attitudes Scale (MHSAS), developed by Hammer, Parent, and Spiker (2018), is a 9-item self-report instrument designed to assess individuals' overall attitudes toward seeking help from mental health professionals. Each item is rated on a 7-point semantic differential scale (e.g., harmful-beneficial, useless-useful), with higher scores indicating more positive attitudes toward mental health help-seeking. The MHSAS has demonstrated strong psychometric properties, including high internal consistency with a Cronbach's alpha of approximately .93, and strong test-retest reliability. The scale has also shown construct validity, being significantly correlated with related variables such as stigma, norms, and intention to seek help.

   Measured: at pre-assessment, after 5 weeks at post-assessment

5. Motivation and Attitudes Toward Changing Health (MATCH)

   The Motivation and Attitudes Toward Changing Health (MATCH) scale, developed by Hessler et al. (2018) at the Behavioral Diabetes Institute, is a concise 9-item self-report measure designed to evaluate patients' readiness for health-related behavior change. It includes three subscales: Willingness to Change, Perceived Ability to Change, and Belief that Change is Worthwhile, each containing 3 items. Responses are rated on a 5-point Likert scale, with some items reverse-scored. The MATCH scale has shown acceptable internal consistency, with Cronbach's alpha values ranging from 0.61 to 0.74 across subscales, and has demonstrated good construct validity.

   Measured: at pre-assessment, after 5 weeks at post-assessment

6. Digit Span Test ( Backward and Forward)

   The Digit Span Test, a subtest of the Wechsler Adult Intelligence Scale (WAIS), is used to assess attention, concentration, and working memory. It includes two components: Digit Span Forward and Digit Span Backward. In the Forward task, participants repeat a sequence of numbers in the same order as presented, primarily measuring attention span and short-term memory. In the Backward task, participants repeat the numbers in reverse order, assessing working memory and mental manipulation abilities. Typically, performance is higher on the forward span than the backward span due to the increased cognitive demands of the latter. The Digit Span Test has demonstrated adequate internal consistency and reliability, with reported Cronbach's alpha values ranging from .80 to .90, indicating strong psychometric properties for assessing cognitive functioning related to attention and memory.

   Measured: at pre-assessment, after 5 weeks, post-assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted23 Dec 2025
2. Study startJan 2026 (estimated)
3. Primary completion31 Jul 2026 (estimated)
4. Study completion31 Aug 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Patients With Major Depressive DisorderStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.