Cognitive Behavior Therapy Among Patients With Major Depressive Disorder-Multiple Episodes.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorGovernment College University Faisalabad
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 .
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavior Therapy
BehavioralThis 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)
DrugParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: 1st Arm (1- Experimental)Experimental treatment 2 interventions
Group B: 2nd Arm (Waitlist Control Condition)Active comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
at pre-Assessment, after 5 weeks at post-Assessment2
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.
Time frame
at Pre-Assessment, after 5 weeks at post-Assessment3
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.
Time frame
at pre-assessment, after 5 weeks at post-assessment4
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.
Time frame
at pre-assessment, after 5 weeks at post-assessmentSponsors and contacts
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Source ClinicalTrials.gov
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