Spirituality with cognitive behavior therapy can reduce demoralization of patient undergoing cancer therapy,chronic renal diseases or skin diseases

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2013/12/004243
• Date of registration: 26-12-2013
• Prospective Registration: Yes
• Primary sponsor: self financed
• Public title: Spirituality with cognitive behavior therapy can reduce demoralization of patient undergoing cancer therapy,chronic renal diseases or skin diseases
• Scientific title: International Multicentre Randomized Clinical Trial on the outcomes using the Spiritually Augmented Cognitive Behavior therapy for a cohort of Patients with Demoralization and Depression
• Date of first enrolment: 15-01-2014
• Target sample size: 180
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7784
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Other Method of allocation concealment:Alternation Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

Fiji, India

Contacts

• Name: Chanu Bhattacharya
• Affiliation: Fr.Muller College of Nursing Mangalore

• Name: Chanu Bhattacharya
• Affiliation: Fr.Muller College of Nursing Mangalore

Key inclusion & exclusion criteria

Inclusion criteria: Patients between the age group of 21 to 65years

The patients with the diagnosis of cancer, skin disorders and undergoing dialysis

Demoralization scale

Beckâ??s Depression Inventory


Exclusion criteria: Patient with acute psychosis

Patient diagnosed with drug and alcohol dependence

Patient who have suicidal ideation



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients with the diagnosis of cancer, chronic skin disease and chronic kidney diseases

Intervention(s)

Intervention1: Spiritually Augmented Cognitive behavioral therapy: Generally the therapy takes place over 10 to 16 sessions for about 60 minutes duration, with flexibility to allow for between 45 to 70 minutes. The initial two weeks might allow for two sessions per week, if necessary and where possible. This will aid engagement and is appropriate to the level of distress patients generally are experiencing. Further, this could positively influence the building of trust and therapeutic alliance â?? a key component in achieving successful outcomes in most psychological interventions. Thereafter sessions follow on a weekly basis. The assessment of termination needs and relapse prevention needs in the form of scheduling booster sessions must start early in the therapy. This ensures the place in predicting and planning for the patientâ??s needs later in therapy and further down. For ethical reasons the therapy may continue past the 10 to 16 sessions if the patient desires this and there is mutual agreement with the patient and therapist with regards to this need. Post study weaning sessions will follow for 2 weeks with 1 session per week.
Control Intervention1: Basic supportive enquiry: Generally the therapy takes place over 10 to 16 sessions for about 60 minutes duration, with flexibility to allow for between 45 to 70 minutes. The initial two weeks might allow for two sessions per week,where the therapist will provide non specific supportive care and safety monitoring.Post study weaning sessions will follow for 2 weeks with 1 session per week.

Primary Outcome(s)

Improvement in demoralization score.Timepoint: 12-16 weeks

Secondary Outcome(s)

effectiveness of SACBTTimepoint: 18 months

Secondary ID(s)

FMMC/FMIEC/1416/2013/12/10/vr02 02

Source(s) of Monetary Support

Father Muller Charitable Institutions

Ethics review

Status: Approved
Approval date: 12/10/2013
Contact:

Father Muller Institutional Ethical Committee