Intervention: Effect of structured goal-oriented psychotherapy modifying dysfunctional emotions behaviors and thoughts Outcome: on improving diabetes self-confidence Participants: among diabetic patients

A study to evaluate the effectiveness of Cognitive Behavioral Therapy on self-efficacy among diabetic patients in a selected community, Coimbatore - No

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109287

Enrollment

100

Registered

2026-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy program consists of 8 structured sessions over 4 weeks (2 sessions per week, 60 minutes each): Session 1-2: Introduction t

Session 3-4: Cognitive restructuring techniques

Session 5-6: Behavioral activation and problem-solving

Session 7-8: Stress management and relapse prevention. Control Intervention1: Standard Care: Routine diabetes education and medical management only.

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with Type 2 diabetes mellitus for at least 6 months; Age between 30-65 years; HbA1c levels between 7-10%; Ability to understand and communicate in English or Tamil; Willingness to participate in the study.

Exclusion criteria

Exclusion criteria: Patients with Type 1 diabetes mellitus; Patients with severe diabetic complications (end-stage renal disease, severe retinopathy); Patients with severe mental illness or cognitive impairment; Pregnant women with gestational diabetes; Patients currently receiving psychological therapy.

Design outcomes

Primary

Measure	Time frame
Mean change in total score on the Diabetes Self-Efficacy Scale (DSES) from pre-test to post-test. The 8-item scale measures confidence in diabetes self-care activities on a 10-point scale (1=not confident at all, 10=totally confident). Total scores range from 8-80, with higher scores indicating greater self-efficacy.Timepoint: T0 (Baseline)Day 0Pre-test assessment of self-efficacy T1 (Post-test)4 weeksImmediate post-test after CBT completion T2 (Follow-up)8 weeksTo evaluate sustainability of effect (Information Required - not in your original proposal)	—

Measure

Time frame

Mean change in total score on the Diabetes Self-Efficacy Scale (DSES) from pre-test to post-test. The 8-item scale measures confidence in diabetes self-care activities on a 10-point scale (1=not confident at all, 10=totally confident). Total scores range from 8-80, with higher scores indicating greater self-efficacy.Timepoint: T0 (Baseline)Day 0Pre-test assessment of self-efficacy T1 (Post-test)4 weeksImmediate post-test after CBT completion T2 (Follow-up)8 weeksTo evaluate sustainability of effect (Information Required - not in your original proposal)

—

Secondary

Measure	Time frame
Mean change in HbA1c levels & fasting blood glucose levels from baseline to post-testTimepoint: Baseline (Day 0) & Post-test at 5 weeks (one week after completion of 4-week CBT intervention)	—

Countries

India

Contacts

Public ContactDr Jeyadeepa R

PSG College of Nursing

jeyadeepa@psgnursing.ac.in8921698754

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026