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Brief Culturally Adapted Cognitive Behaviour Therapy for Depression

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ClinicalTrials.gov Identifier: NCT01799551
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Fraooq Naeem, Pakistan Association of Cognitive Therapists

Brief Summary:
Cognitive behaviour therapy (CBT) has an effective evidence base in the west and is recommended by the national bodies in many countries in the West. Our group has adapted CBT for depression and psychosis in Pakistan for use with local clients. Initial evaluations have found that these therapies are effective. However, due to the financial restraints it would be useful if the investigators find that brief version of the CBT might be applicable and effective in non western cultures. Therefore in this study, the investigators will be testing effectiveness of brief version of culturally adapted CBT for depression in a randomized controlled trial (RCT) in Pakistan.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Ca CBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Brief Culturally Adapted CBT for Depression in Pakistan
Study Start Date : November 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Ca CBT
Experimental arm will receive brief version of Culturally adapted CBT for depression. This is based on our previous work in which we adapted CBT for depression in Pakistan
Behavioral: Ca CBT
Clients in intervention group will receive a CBT intervention using a manual. Intervention was developed for use in primary and secondary care using a series of qualitative studies (Naeem et al a, 2010, Naeem et al c, 2009, Naeem et al, 2009, Naeem et al, in press) during the last 5 years in Pakistan and has proven to be effective in a pilot study (Naeem et al, 2011). Intervention will consist of 6 sessions and will focus on psycho-education, symptoms management, changing negative thinking, problem solving, improving relationships and communication skills. One person from the family will be involved as a facilitator.
Other Name: Culturally adapted Brief Cognitive Behaviour Therapy

No Intervention: Treatment As Usual
Patients in this arm will get only Treatment As Usual, which normally includes regular follow up and medicines.



Primary Outcome Measures :
  1. Hospital Anxiety and depression Rating Scale- Depression subscale [ Time Frame: Participants will be assessed at baseline and then end of therapy at 12 weeks ]
    Measurement of depression


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale, Anxiety subscale [ Time Frame: Participants will be assessed at baseline and then end of therapy at 12 weeks ]
    Measurement of anxiety

  2. Bradford Somatic Inventory [ Time Frame: Participants will be assessed at baseline and then end of therapy at 12 weeks ]
    Measurement of somatic symptoms

  3. Brief disability questionnaire [ Time Frame: Participants will be assessed at baseline and then end of therapy at 12 weeks ]
    To measure disability associated with depression



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All those who fulfil the diagnostic criteria of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on interviews using SCAN Urdu version),
  • Are between the ages of 19-60,
  • Score 8 or more on HADS, Depression Subscale, and
  • Who live within traveling distance of the psychiatry department will be approached

Exclusion Criteria:

  • Excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence)
  • Significant cognitive impairment (for example learning disability or dementia) and
  • Active psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799551


Locations
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Pakistan
Pakistan Association of Cognitive Therapists
Lahore, Pakistan
Sponsors and Collaborators
Pakistan Association of Cognitive Therapists
Investigators
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Principal Investigator: Farooq Naeem, MRCPsych,PhD Pakistan Association of Cognitive Therapists
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Responsible Party: Fraooq Naeem, President, Pakistan Association of Cognitive Therapists, Pakistan Association of Cognitive Therapists
ClinicalTrials.gov Identifier: NCT01799551    
Other Study ID Numbers: PakistanACT
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by Fraooq Naeem, Pakistan Association of Cognitive Therapists:
Depression
Culture
CBT
Adaptation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders