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

Efficacy of Unified Protocol for Depression: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070358
Enrollment
70
Registered
2024-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: It is an empirical, emotion-focussed cognitive-behavioural therapy which focusses on changing core emotional proce

Sponsors

Kezia Iris Christopher
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Severity in Depression ScoresTimepoint: Baseline Post Intervention 3-month followup

Secondary

MeasureTime frame
Severity of Anxiety Severity of Depression(Self-report) Emotion Regulation Distress Tolerance Experiential Avoidance Affect Beliefs Cognitive Flexibility Working AllianceTimepoint: Baseline Mid-Intervention Post Intervention 3-month Followup

Countries

India

Contacts

Public ContactKezia Iris Christopher

National Institute of Mental Health and Neuro Sciences

drmanjula71@gmail.com9632603597

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026