The Effect of Combination Mindfulness Spiritual-Based Cognitive Therapy Plus Hypnosis in HIV Patients With Depression

NCT05659472 | Completed

• 1 other identifier: Eny Pujiati
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

HIV/AIDS patients are at risk for depression, a multifactorial disorder with signs and symptoms that affect the cognitive, affective, behavioral, and somatic areas. This study used Randomized Controlled Clinical Trials (RCT). Main hypothesis: A combination of spiritual awareness-based cognitive therapy (MSBCT) plus hypnotic interventions can reduce depression degree scores by reducing cortisol levels and increasing serotonin levels in HIV patients with depression. Small hypothesis

1. 1.There was a decrease in cortisol levels after being given the MSBCT plus hypnosis combination intervention in HIV patients with depression;
2. 2.There was an increase in serotonin levels after being given the MSBCT plus hypnosis combination intervention in HIV patients with depression;
3. 3.There was a decrease in depression degree scores after being given the MSBCT plus hypnosis combination intervention in HIV patients with depression;
4. 4.There was a higher reduction in cortisol levels in the intervention group compared to the control group in HIV patients with depression;
5. 5.There was a higher increase in serotonin levels in the intervention group compared to the control group in HIV patients with depression;
6. 6.There was a higher reduction in scores degree of depression in the intervention group compared to the control group in HIV patients with depression;
7. 7.Decreased cortisol levels and increased serotonin levels affect depression degree scores in HIV patients with depression;
8. 8.MSBCT plus hypnosis combination intervention is a factor that can affect depression degree scores reduction in HIV patients with depression;

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

• Decreased serum cortisol levels

  Serum cortisol levels were measured using the ELISA kit catalog method number CO103S in the GAKI laboratory, Faculty of Medicine, Diponegoro University - Semarang - Indonesia

  Before intervention, and 8 weeks after intervention

• Increased serum serotonin levels

  Serum serotonin levels were measured using the ELISA kit catalog method number E - EL-H0033 in the GAKI laboratory, Faculty of Medicine, Diponegoro University - Semarang - Indonesia

  Before intervention, and 8 weeks after intervention

• Decreased degree scores of depression

  Depression degree scores were measured using the Beck Depression Inventory (BDI) II

  Before intervention, and 8 weeks after intervention

Study Arms (2)

Intervention group = Combination mindfulness spiritual-based cognitive therapy plus hypnosis

EXPERIMENTAL

Given to the intervention group with a frequency of once a week for eight weeks. Each session for 120 minutes or 2 hours with a set of MSBCT intervention packages resulting from modified mindfulness-based cognitive therapy with using the mindfulness concept of Kabat Zinn and the five-step model of mindfulness developed by Vidyamala Burch.

Behavioral: Combination mindfulness spiritual-based cognitive therapy plus hypnosis

Control group = Mindfulness-based cognitive therapy

EXPERIMENTAL

Given to the control group with a frequency of once a week for eight weeks. Each session is 90 minutes or 1.5 hours with a set of MBCT intervention packages developed by Teasdale, 2014

Behavioral: Mindfulness-based cognitive therapy

Interventions

Combination mindfulness spiritual-based cognitive therapy plus hypnosis BEHAVIORAL

The intervention was divided into eight components in eight sessions, namely (1) psychoeducation and intention, (2) awareness of breathing mindfulness, (3) body scan, (4) comfort training through daily activity/comfort exercises, (5) self-compassion / having a great soul with acceptance, gratitude, and sincerity, (6) planning happiness through independent healthy behavior targets, (7) independent healthy behavior (8) independent healthy behavior evaluation. Each therapeutic component of each session is further divided into three sub-components, namely psychoeducation, training, and hypnosis.

Also known as: Combination MSBCT plus hypnosis

Intervention group = Combination mindfulness spiritual-based cognitive therapy plus hypnosis

Mindfulness-based cognitive therapy BEHAVIORAL

The program curriculum consists of the automatic pilot; living in our heads; gathering the scattered mind; recognizing aversion; allowing and letting be; thoughts as thoughts; kindness in action; maintaining and extending new learning.

Also known as: MBCT

Control group = Mindfulness-based cognitive therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HIV patients with mild-moderate depression;
• Receiving ARV therapy;
• Islam;
• Aged 18-60 years;
• Not taking steroid and serotonin medications;
• Willing to sign the informed consent;

You may not qualify if:

• Having a history of immune disorders or allergies;
• Currently undergoing hormonal or corticosteroid therapy;
• Patients who used herbal medicine 2 weeks before the study;
• Patients with psychiatric comorbidities and emergency conditions.

Sponsors & Collaborators

• Health Technology Institute of Cendekia Utama Kudus: lead

Study Sites (1)

Eny Pujiati

Kudus, Middle Java, 59372, Indonesia

Location

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MeSH Terms

Conditions

Depression

Interventions

Hypnosis; Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy

Study Officials

• Eny Pujiati, M.Kes

  Health Technology Institute of Cendekia Utama Kudus - Middle Java - Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The process of randomization to determine the respondents into the intervention and control groups without being known by the researchers and respondents. Assessment of cortisol, serotonin, and depression levels was not known by researchers, respondents, and care providers and was only known by the outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group was given a combination of mindfulness spiritual-based cognitive therapy (MSBCT) plus hypnosis and the control group was given mindfulness-based cognitive therapy (MBCT).

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: December 12, 2020
• Primary Completion: April 10, 2021
• Study Completion: April 10, 2021
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)