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

Depression Clinical Trial

Official title:

The Effect of Combination Mindfulness Spiritual-Based Cognitive Therapy Plus Hypnosis on Levels of Cortisol, Serotonin, and Depression Degree in HIV Patients With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659472
• Other study ID #: Eny Pujiati
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: April 10, 2021

Study information

• Verified date: December 2022
• Source: Health Technology Institute of Cendekia Utama Kudus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Description:

HIV/AIDS patients are at risk for depression. Evidence shows that depression in HIV/AIDS patients is two to four times higher than in the general population. The prevalence of depression in HIV/AIDS patients varies from 5% to 79% worldwide while the prevalence of depression in Indonesia in 2018 was 21.8% where women (22.3%) had a higher depression rate than men (21,4%). Cases of depression in HIV/AIDS patients are estimated to have a frequency of up to 60% of the total existing cases of depression. Depressive disorders are caused by biopsychosocial factors and neurotransmitter interactions that affect pathophysiology in a complex manner. The monoaminergic neurotransmitters that play the most role in depression are serotonin (5-HT), norepinephrine (NE), and dopamine (DA). In people with maladaptive PLHIV, cortisol levels in the blood will increase thereby inhibiting cellular and humoral immune responses. This condition causes apoptosis not to occur so that the virus proliferates and spreads rapidly. The progressive effect of HIV/AIDS can infect the central nervous system thereby disrupting the balance of neurotransmitters, accelerating viral replication, and suppressing the immune response so that it can shorten the period of HIV without symptoms. This condition, if not handled properly can reduce the quality of life, weaken physical function and therapeutic effects, as well as higher medical co-morbidities including suicidal behavior. Although the prevalence is quite high, the efficacy of depression therapy is currently not satisfactory. Less than 50% of depressed patients respond to standard therapy and 70% relapse. Psychopharmacology, psychotherapy, and a combination of the two are effective for treating depression and preventing the recurrence of depression. Psychopharmacological therapy has a shorter impact than psychotherapy. Even today, many people switch from medical therapy to psychotherapy because of the high medical costs and the side effects of pharmacological therapy. Therefore, equipping HIV/AIDS patients with coping strategies to manage physiological and psychological problems is integral to part of providing comprehensive care to HIV/AIDS patients. The results of the meta-analysis reported that mindfulness-based therapy was effective in reducing symptoms of stress, anxiety, and depression. There is empirical evidence supporting the effectiveness of MBCT in reducing rates of depression and improving the quality of life in chronic disease patients. However, the study results have not been consistent. Two resources that are widely used by patients with mental and physical illnesses are psychotherapy and religion/spirituality. The results of a meta-analysis of 46 spiritual intervention studies reported that patients with spiritually integrated psychotherapy showed positive improvement compared to patients treated only with psychotherapy. On this basis, researchers are trying to develop MBCT psychotherapy with spiritually integrated MBCT, namely a mindfulness-based intervention that integrates Islamic spiritual values (gratitude, patience, pleasure, sincerity, and trustworthiness) with aspects of cognitive behavioral therapy (CBT) and focuses on current conditions, emphasizes acceptance of thoughts, emotions, and behavior by improving thought processes, controlling emotions, and bodily sensations in order to develop self-capacity effectively in dealing with problems. Positive self-capacity development can occur and be effective when having the basic principles of positive life in the subconscious mind. One way to explore the subconscious mind can be done with hypnosis. Hypnosis is a method of giving suggestions by penetrating the critical factors of the conscious mind into the subconscious mind. Hypnosis has also been shown to be significant in reducing stress, anxiety, and depression scores. Even hypnosis plays a significant role as the first step in treating depression. This makes researchers try to develop a spiritually integrated MBCT psychotherapy combined with hypnosis. Formulation of the problem Can a combination intervention of mindfulness spiritual-based cognitive therapy (MSBCT) plus hypnosis reduce depression degree scores by reducing cortisol levels and increasing serotonin levels in HIV patients with depression? Research purposes The research aims to prove that a combination intervention of mindfulness spiritual-based cognitive therapy (MSBCT) plus hypnosis can reduce depression degree scores by decreasing cortisol levels and increasing serotonin levels in HIV patients with depression. Research hypothesis A combination intervention of mindfulness spiritual-based cognitive therapy (MSBCT) plus hypnosis can reduce depression degree scores by reducing cortisol levels and increasing serotonin levels in HIV patients with depression. Benefits of research results Provide scientific information about the effects interventions of a combination of mindfulness spiritual-based cognitive therapy (MSBCT) plus hypnosis in reducing cortisol levels, increasing serotonin levels, and reducing the scores degree of depression in HIV patients with depression; Research methods A randomized controlled trial (RCT). The sampling used a consecutive sampling method, namely a sampling technique based on inclusion and exclusion criteria for selecting predetermined subjects, within a certain period of time until the number of research subjects was fulfilled. After selecting the subjects, the randomization process was carried out using random allocation. The enumerator determined that each group consisted of 31 subjects in the intervention group and 31 subjects in the control group. Randomization used the simple randomization technique, namely by making 62 envelopes, each with 31 envelopes bearing the combination of MSBCT plus Hypnosis and 31 envelopes bearing the words MBCT. All envelopes were randomized and each subject who met the research criteria received one envelope chosen by the enumerator without the researcher and the subject knowing about it. If the envelope taken contains the writing of the MSBCT plus Hypnosis combination then the subject is included in the intervention group sample and the one containing the MBCT writing is included in the control group sample. The intervention was given once a week for 8 weeks. The assessment was carried out 2 times pre and post-intervention by assessing cortisol levels, serotonin levels, and depression degree scores in the control and intervention groups. Statistical tests used the Independent T-test if the data were normally distributed, the Mann Whitney U Test if the data were not normally distributed, and to see the effect of the intervention using a linear regression test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 10, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. HIV patients with mild-moderate depression;

2. Receiving ARV therapy;

3. Islam;

4. Aged 18-60 years;

5. Not taking steroid and serotonin medications;

6. Willing to sign the informed consent;

Exclusion Criteria:

1. Having a history of immune disorders or allergies;

2. Currently undergoing hormonal or corticosteroid therapy;

3. Patients who used herbal medicine 2 weeks before the study;

4. Patients with psychiatric comorbidities and emergency conditions.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Combination mindfulness spiritual-based cognitive therapy plus hypnosis
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.
• Mindfulness-based cognitive therapy
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.

Locations

Country	Name	City	State
Indonesia	Eny Pujiati	Kudus	Middle Java

Sponsors (1)

Lead Sponsor	Collaborator
Health Technology Institute of Cendekia Utama Kudus

Country where clinical trial is conducted

Indonesia, 

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Decreased degree scores of depression	Depression degree scores were measured using the Beck Depression Inventory (BDI) II	Before intervention, and 8 weeks after intervention