Clinical trial NCT05659472: The Effect of Combination Mindfulness Spiritual-Based Cognitive Therapy Plus Hypnosis in HIV Patients With Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Health Technology Institute of Cendekia Utama Kudus
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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. 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;

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Decreased serum cortisol levels
timeFrame: Before intervention, and 8 weeks after intervention
measure: Increased serum serotonin levels
timeFrame: Before intervention, and 8 weeks after intervention
measure: Decreased degree scores of depression
timeFrame: Before intervention, and 8 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kudus
country: Indonesia
facility: Eny Pujiati
state: Middle Java
Study officials:
affiliation: Health Technology Institute of Cendekia Utama Kudus - Middle Java - Indonesia
name: Eny Pujiati, M.Kes
role: PRINCIPAL_INVESTIGATOR
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