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DepressionNCT05659472

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

A study testing Combination mindfulness spiritual-based cognitive therapy plus hypnosis and Mindfulness-based cognitive therapy in people with Depression, run by Health Technology Institute of Cendekia Utama Kudus at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Depression
What is being tested?
Combination mindfulness spiritual-based cognitive therapy plus hypnosis and Mindfulness-based cognitive therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteIndonesia
Study dates
12 Dec 2020to 10 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Eny Pujiati

    Kudus, Middle Java, 59372

Other trials in Indonesia

About this study

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

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.

Read more

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;
Read the 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.

Conditions
Depression
Being tested
Combination mindfulness spiritual-based cognitive therapy plus hypnosis, Mindfulness-based cognitive therapy
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination mindfulness spiritual-based cognitive therapy plus hypnosisBehavioural

    Also called Combination MSBCT 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 therapyBehavioural

    Also called MBCT

    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.

Study groups in NCT05659472
Study groupRoleWhat they receive
Intervention group = Combination mindfulness spiritual-based cognitive therapy plus hypnosisExperimentalGiven 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.
Receives: Behavioral: Combination mindfulness spiritual-based cognitive therapy plus hypnosis
Control group = Mindfulness-based cognitive therapyExperimentalGiven 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
Receives: Behavioral: Mindfulness-based cognitive therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Before intervention, and 8 weeks after intervention

  2. 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

    Measured: Before intervention, and 8 weeks after intervention

  3. Decreased degree scores of depression

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

    Measured: Before intervention, and 8 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start12 Dec 2020
  3. Primary completion10 Apr 2021
  4. Study completion10 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05659472
Sponsor's protocol ID
Eny Pujiati
Status last verified
Dec 2022
First submitted
5 Dec 2022
Last updated
21 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I did'd have a plan share the date

Publications

  • Asangbeh SL, Sobngwi JL, Ekali GL, Eyoum C, Msellati P. Predictors of depression among patients on art in a rural health district in North West Cameroon. AIDS Care. 2016;28(2):205-8. doi: 10.1080/09540121.2015.1074654. Epub 2015 Aug 19.

    PubMed 26288104
  • Bernard C, Dabis F, de Rekeneire N. Prevalence and factors associated with depression in people living with HIV in sub-Saharan Africa: A systematic review and meta-analysis. PLoS One. 2017 Aug 4;12(8):e0181960. doi: 10.1371/journal.pone.0181960. eCollection 2017.

    PubMed 28783739
  • Dejman M, Ardakani HM, Malekafzali B, Moradi G, Gouya MM, Shushtari ZJ, Alinaghi SA, Mohraz M. Psychological, Social, and Familial Problems of People Living with HIV/AIDS in Iran: A Qualitative Study. Int J Prev Med. 2015 Dec 23;6:126. doi: 10.4103/2008-7802.172540. eCollection 2015.

    PubMed 26900440
  • Nanni MG, Caruso R, Mitchell AJ, Meggiolaro E, Grassi L. Depression in HIV infected patients: a review. Curr Psychiatry Rep. 2015 Jan;17(1):530. doi: 10.1007/s11920-014-0530-4.

    PubMed 25413636
  • Feuillet P, Lert F, Tron L, Aubriere C, Spire B, Dray-Spira R; Agence Nationale de Recherche sur le Sida et les Hepatites Virales (ANRS)-VIH: Enquete sur les personnes atteintes (Vespa2) Study Group. Prevalence of and factors associated with depression among people living with HIV in France. HIV Med. 2017 Jul;18(6):383-394. doi: 10.1111/hiv.12438. Epub 2016 Sep 14.

    PubMed 27625202
  • Wang T, Fu H, Kaminga AC, Li Z, Guo G, Chen L, Li Q. Prevalence of depression or depressive symptoms among people living with HIV/AIDS in China: a systematic review and meta-analysis. BMC Psychiatry. 2018 May 31;18(1):160. doi: 10.1186/s12888-018-1741-8.

    PubMed 29855289
  • Uthman OA, Magidson JF, Safren SA, Nachega JB. Depression and adherence to antiretroviral therapy in low-, middle- and high-income countries: a systematic review and meta-analysis. Curr HIV/AIDS Rep. 2014 Sep;11(3):291-307. doi: 10.1007/s11904-014-0220-1.

    PubMed 25038748
  • Peltzer K, Pengpid S. High prevalence of depressive symptoms in a national sample of adults in Indonesia: Childhood adversity, sociodemographic factors and health risk behaviour. Asian J Psychiatr. 2018 Mar;33:52-59. doi: 10.1016/j.ajp.2018.03.017. Epub 2018 Mar 7.

    PubMed 29529418
  • Rivera-Rivera Y, Vazquez-Santiago FJ, Albino E, Sanchez MD, Rivera-Amill V. Impact of Depression and Inflammation on the Progression of HIV Disease. J Clin Cell Immunol. 2016 Jun;7(3):423. doi: 10.4172/2155-9899.1000423. Epub 2016 Jun 3.

    PubMed 27478681
  • Anacker C. Adult hippocampal neurogenesis in depression: behavioral implications and regulation by the stress system. Curr Top Behav Neurosci. 2014;18:25-43. doi: 10.1007/7854_2014_275.

    PubMed 24478038
  • van Bodegom M, Homberg JR, Henckens MJAG. Modulation of the Hypothalamic-Pituitary-Adrenal Axis by Early Life Stress Exposure. Front Cell Neurosci. 2017 Apr 19;11:87. doi: 10.3389/fncel.2017.00087. eCollection 2017.

    PubMed 28469557
  • Islam MR, Islam MR, Ahmed I, Moktadir AA, Nahar Z, Islam MS, Shahid SFB, Islam SN, Islam MS, Hasnat A. Elevated serum levels of malondialdehyde and cortisol are associated with major depressive disorder: A case-control study. SAGE Open Med. 2018 May 9;6:2050312118773953. doi: 10.1177/2050312118773953. eCollection 2018.

    PubMed 29770218
  • Kambeitz JP, Howes OD. The serotonin transporter in depression: Meta-analysis of in vivo and post mortem findings and implications for understanding and treating depression. J Affect Disord. 2015 Nov 1;186:358-66. doi: 10.1016/j.jad.2015.07.034. Epub 2015 Jul 31.

    PubMed 26281039
  • Practice guideline for the treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry. 2000 Apr;157(4 Suppl):1-45. No abstract available.

    PubMed 10767867
  • Geurts DEM, Compen FR, Van Beek MHCT, Speckens AEM. The effectiveness of mindfulness-based cognitive therapy for major depressive disorder: evidence from routine outcome monitoring data. BJPsych Open. 2020 Nov 25;6(6):e144. doi: 10.1192/bjo.2020.118.

    PubMed 33234183

Questions about this trial

What is this clinical trial studying?

A study testing Combination mindfulness spiritual-based cognitive therapy plus hypnosis and Mindfulness-based cognitive therapy in people with Depression, run by Health Technology Institute of Cendekia Utama Kudus at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decreased serum cortisol levels (time frame: Before intervention, and 8 weeks after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05659472, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.

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