NCT06302712

Brief Summary

The current study aims to determine the effectiveness of the first culturally adapted Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims with OCD in Pakistan along with the module effectiveness in reducing OCD symptoms with comorbidities like anxiety, depression, stress, thought control, thought-action fusion, and enhancing the spiritual quality of life of participants.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 4, 2024

Last Update Submit

March 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive Compulsive Scale

    Yale Brown Obsessive Compulsive is a 10-item self-report scale developed to assess the severity of both obsession and compulsion. Minimum score is 0 and maximum score is 40. The higher the scores mean the worst outcome. Cut-off Scores: 0-7 (sub-clinical) 8-15 (Mild) 16-23 (Moderate) 24-31 (severe) 32-40 (Extrerme)

    8 weeks

Secondary Outcomes (4)

  • Depression, Stress, Anxiety

    8 Weeks.

  • Thought Action Fusion

    8 weeks

  • Thought Control

    8 weeks

  • Spiritual Quality

    8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Traditional Islamically Integrated Psychotherapy

TAU

NO INTERVENTION

Interventions

Traditional Islamically Integrated Psychotherapy for OCD. We will be using the culturally adapted module of TIIP that is translated into the Urdu language for Pakistan Muslims with OCD. The treatment module is mainly based on four domains Nafs (Behavior), Ihsas (Emotions), Aql (Thought), and Ruh (Spirituality). The session will be conducted in an individual format, with eight sessions, and the intervention will be conducted by a certified therapist in TIIP.

Intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The client diagnosed with OCD according to DSM-5-TR.
  • The minimum score on Y-BOCS is 08 (i.e., indicating moderate level of symptoms)
  • The age range is from 18 to 40 years
  • The client has a minimum of eight years of formal education

You may not qualify if:

  • The client is having a comorbid diagnosis of severe psychiatric illness (e.g., psychotic disorders, personality disorder, substance use disorder, neurocognitive disorder)
  • The client is having a comorbidity of chronic physical illness
  • The client refused to sign the informed consent form,
  • The client has experience undergoing manualized faith-based CBT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor.

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 30, 2024

Last Updated

March 18, 2024

Record last verified: 2024-03