A clinical trial to test the effect of emotion regulation based intervention in patients with depressio

Not Applicable

Conditions: Health Condition 1: F321- Major depressive disorder, singleepisode, moderate

Registration Number: CTRI/2024/07/070358

Lead Sponsor: Kezia Iris Christopher

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Individuals with a principle diagnosis of moderate to severe depression, single episode and recurrent according to the DSM V criteria with or without other comorbid Axis I diagnosis or Axis II traits as assessed and screened by DIAMOND and SCID-V PD.

2. Patients who are fluent and conversant in English or Tamil, with an ability to read English.

3. Patients whose symptoms are stabilized with medication for at least 4 weeks.

4. Patients willing to commit to 3-4 months of therapy.

Exclusion Criteria

1. Patients with other Axis I or II primary diagnosis, other neurological, neurodevelopmental disorders or any other organic cause that can affect engagement in therapy.

2. Individuals having depression with psychotic symptoms.

3. Patients who have substance use disorder, with immediate need for detox.

4. Patients who are already in therapy and have had over 5 sessions in the past 3 months.

5. Patients with high suicidality or those whose symptoms interfere in the therapy process as assessed clinically during intake or screening.

6. Women who are pregnant or meet criteria for post-partum depression.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity in Depression ScoresTimepoint: Baseline <br/ ><br>Post Intervention <br/ ><br>3-month followup

Secondary Outcome Measures

Name	Time	Method
Severity of Anxiety <br/ ><br>Severity of Depression(Self-report) <br/ ><br>Emotion Regulation <br/ ><br>Distress Tolerance <br/ ><br>Experiential Avoidance <br/ ><br>Affect <br/ ><br>Beliefs <br/ ><br>Cognitive Flexibility <br/ ><br>Working AllianceTimepoint: Baseline <br/ ><br>Mid-Intervention <br/ ><br>Post Intervention <br/ ><br>3-month Followup