The Impact of Spiritual Healing on Moderate Depression in Adults

NCT04766242 | Unknown

• 1 other identifier: 63692
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is a common mental disorder and is together with anxiety the global leading cause of all non-fatal burden of disease. Currently supported treatment for depression is antidepressant medication and different psychotherapeutic interventions. Many patients experience, however, adverse effects of antidepressant medication, while at the same time the access to psychotherapeutic interventions are limited. This is particularly the case for patients suffering from moderate depression. Many patients who suffer from depression turn to complementary and alternative medicine (CAM), and among those therapies often spiritual healing. There is some evidence that consulting a spiritual healer can be beneficial for patients suffer from depression, and that spiritual healing is associated with low risk. The objective of this study is therefor to conduct a pilot RCT (spiritual healing as addition to usual care versus usual care alone) in preparation of a larger trial in adults with moderate depression to examine feasibility and individuals' experience of spiritual healing. This study is a pilot randomized controlled trial (RCT) with two parallel groups. A total of 28 adult patients with moderate depression according to the M.I.N.I. PLUS DSM-V criteria will be randomized to spiritual healing in addition to usual care intervention (n=14) or usual care alone (n=14). Ten treatment sessions (lasting 45-60 minutes each) of spiritual healing will be administered as an adjunct to usual care and compared to usual care alone. Reduction in depression symptoms will be measured with Beck Depression Inventory (BDI) and Montgomery and Åsberg Depression Rating Scale (MADRS) collected at baseline, week 8 and 16, in addition to BDI measurement collected 6 and 12 months after inclusion in the study. To investigate participants' experience with spiritual healing, a qualitative study will be included using a phenomenological hermeneutical method and semi-structured interviews.

Conditions

Moderate Depression

Outcome Measures

Primary Outcomes (1)

• Feasibility of the study

  • Recruitment speed. * The recruitment speed will be recorded in a separate form including the following categories: * Dates for first contact with GP * Dates for signed consent form * Dates for baseline data collection * Data for first healing or usual care consultation. * Willingness to be randomized will be collected descriptively. The participants will be interviewed about their willingness to be randomized and asked about pros and cons of randomization and input on how to improve the randomization procedure. * Study adherence will be collected descriptively. The participants will be interviewed about any obstacles in the study flow and possible improvements. * Implementation of healing will be collected descriptively. The participants randomized to healing will be interviewed and asked about the implementation of the healing sessions. The investigators will asked about the participants experiences of the healing treatment (pros and cons).

  through study completion, an average of 2 year".

Secondary Outcomes (3)

• Beck Depression Inventory (BDI) rating scale

  Baseline, 8 and 16 weeks

• Montgomery and Åsberg Depression Rating Scale (MADRS)

  Baseline, 8 and 16 weeks, 6 and 12 months.

• Semi-structured interviews

  16 weeks after first participant enrollment until 16 weeks after the last participant has been enroled in the study.

Other Outcomes (1)

• Adverse effects of the treatment

  All through the study

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive 10 healing session of 45-60 minutes as an adjunct to usual care, approximately once a week.The usual care will consist of the treatment plan made by their GP when they were diagnosed with moderate depression.

Other: Spiritual healing; Other: Usual care

Control group

OTHER

The control group will receive usual care as prescribed by their GP when they were diagnosed with moderate depression.

Other: Usual care

Interventions

Spiritual healing OTHER

The spiritual healing will be based on an assessment of the total health situation of the individual patient. Spiritual healing will mainly consist of a treatment where the healers hold their hands for some time at different parts of the patient's body, known as "power points", outside the patients clothing. The consultation might also include possible life-style advice. The treatments will last for 45-60 minutes each time.

Also known as: Healing touch, Reiki, Hands on healing, Healing by hand, Energy healing

Intervention group

Usual care OTHER

The care the general practitioner (GP) prescribe when the patients are diagnosed with moderate depression.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfill the criteria for moderate depression
• Have symptoms for two weeks or more
• A minimum of six of the following nine symptoms must have been present:
• Depressed mood most of the day
• Markedly diminished interest or pleasure in all activities
• Significant weight loss or weight gain (more than 5%)
• Insomnia or hypersomnia
• Psychomotor agitation or retardation
• Fatigue
• Feelings of worthlessness
• Excessive or inappropriate guilt
• Diminished ability to concentrate
• Minimum one of the six symptoms must be either depressed mood or loss of interest and pleasure.

You may not qualify if:

• Symptoms as a direct physiological effects of a substance or a general medical condition
• Substance abuse
• Chronic major or bipolar depression or axis I diagnosis
• Endocrine abnormality; medical disorder or treatment that could cause depression
• Suicidal potential
• Dementia
• Depression due to uncomplicated grief
• History of psychosis or mania
• Heart valve disease
• Poorly controlled hypertension and diabetes mellitus
• Pregnancy
• Inability to complete study forms.

Sponsors & Collaborators

• University of Tromso: lead
• Sorlandet Hospital HF: collaborator

Study Sites (1)

Uit The Arctic University of Norway

Tromsø, Troms, 9102, Norway

Location

Related Publications (24)

• Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.

  PMID: 23993280 BACKGROUND

• Wang PS, Aguilar-Gaxiola S, Alonso J, Angermeyer MC, Borges G, Bromet EJ, Bruffaerts R, de Girolamo G, de Graaf R, Gureje O, Haro JM, Karam EG, Kessler RC, Kovess V, Lane MC, Lee S, Levinson D, Ono Y, Petukhova M, Posada-Villa J, Seedat S, Wells JE. Use of mental health services for anxiety, mood, and substance disorders in 17 countries in the WHO world mental health surveys. Lancet. 2007 Sep 8;370(9590):841-50. doi: 10.1016/S0140-6736(07)61414-7.

  PMID: 17826169 BACKGROUND

• Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.

  PMID: 15939837 BACKGROUND

• Eisenberg D, Golberstein E, Gollust SE. Help-seeking and access to mental health care in a university student population. Med Care. 2007 Jul;45(7):594-601. doi: 10.1097/MLR.0b013e31803bb4c1.

  PMID: 17571007 BACKGROUND

• Druss BG, Rosenheck RA. Use of practitioner-based complementary therapies by persons reporting mental conditions in the United States. Arch Gen Psychiatry. 2000 Jul;57(7):708-14. doi: 10.1001/archpsyc.57.7.708.

  PMID: 10891042 BACKGROUND

• Kessler RC, Soukup J, Davis RB, Foster DF, Wilkey SA, Van Rompay MI, Eisenberg DM. The use of complementary and alternative therapies to treat anxiety and depression in the United States. Am J Psychiatry. 2001 Feb;158(2):289-94. doi: 10.1176/appi.ajp.158.2.289.

  PMID: 11156813 BACKGROUND

• Spinks J, Hollingsworth B. Policy implications of complementary and alternative medicine use in Australia: data from the National Health Survey. J Altern Complement Med. 2012 Apr;18(4):371-8. doi: 10.1089/acm.2010.0817.

  PMID: 22515796 BACKGROUND

• Hansen AH, Kristoffersen AE. The use of CAM providers and psychiatric outpatient services in people with anxiety/depression: a cross-sectional survey. BMC Complement Altern Med. 2016 Nov 11;16(1):461. doi: 10.1186/s12906-016-1446-9.

  PMID: 27835971 BACKGROUND

• Bazargan M, Ani CO, Hindman DW, Bazargan-Hejazi S, Baker RS, Bell D, Rodriquez M. Correlates of complementary and alternative medicine utilization in depressed, underserved african american and Hispanic patients in primary care settings. J Altern Complement Med. 2008 Jun;14(5):537-44. doi: 10.1089/acm.2007.0821.

  PMID: 18537468 BACKGROUND

• Jorm AF, Griffiths KM, Christensen H, Parslow RA, Rogers B. Actions taken to cope with depression at different levels of severity: a community survey. Psychol Med. 2004 Feb;34(2):293-9. doi: 10.1017/s003329170300895x.

  PMID: 14982135 BACKGROUND

• MacPherson H, Thorpe L, Thomas K, Geddes D. Acupuncture for depression: first steps toward a clinical evaluation. J Altern Complement Med. 2004 Dec;10(6):1083-91. doi: 10.1089/acm.2004.10.1083.

  PMID: 15674005 BACKGROUND

• Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008 Feb;5(2):e45. doi: 10.1371/journal.pmed.0050045.

  PMID: 18303940 BACKGROUND

• Arroll B, Elley CR, Fishman T, Goodyear-Smith FA, Kenealy T, Blashki G, Kerse N, Macgillivray S. Antidepressants versus placebo for depression in primary care. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD007954. doi: 10.1002/14651858.CD007954.

  PMID: 19588448 BACKGROUND

• Van Aken R, Taylor B. Emerging from depression: the experiential process of Healing Touch explored through grounded theory and case study. Complement Ther Clin Pract. 2010 Aug;16(3):132-137. doi: 10.1016/j.ctcp.2009.11.001. Epub 2009 Dec 5.

  PMID: 20621272 BACKGROUND

• Shore AG. Long-term effects of energetic healing on symptoms of psychological depression and self-perceived stress. Altern Ther Health Med. 2004 May-Jun;10(3):42-8.

  PMID: 15154152 BACKGROUND

• Richeson NE, Spross JA, Lutz K, Peng C. Effects of Reiki on anxiety, depression, pain, and physiological factors in community-dwelling older adults. Res Gerontol Nurs. 2010 Jul;3(3):187-99. doi: 10.3928/19404921-20100601-01. Epub 2010 Jun 30.

  PMID: 20635803 BACKGROUND

• Joyce J, Herbison GP. Reiki for depression and anxiety. Cochrane Database Syst Rev. 2015 Apr 3;2015(4):CD006833. doi: 10.1002/14651858.CD006833.pub2.

  PMID: 25835541 BACKGROUND

• Kristoffersen AE, Stub T, Knudsen-Baas O, Udal AH, Musial F. Self-Reported Effects of Energy Healing: A Prospective Observational Study With Pre-Post Design. Explore (NY). 2019 Mar-Apr;15(2):115-125. doi: 10.1016/j.explore.2018.06.009. Epub 2018 Aug 22.

  PMID: 30262161 BACKGROUND

• Paterson C, Britten N. In pursuit of patient-centred outcomes: a qualitative evaluation of the 'Measure Yourself Medical Outcome Profile'. J Health Serv Res Policy. 2000 Jan;5(1):27-36. doi: 10.1177/135581960000500108.

  PMID: 10787584 BACKGROUND

• Thompson TD, Weiss M. Homeopathy--what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions. BMC Complement Altern Med. 2006 Nov 13;6:37. doi: 10.1186/1472-6882-6-37.

  PMID: 17101037 BACKGROUND

• Pennebaker JW, Barger SD, Tiebout J. Disclosure of traumas and health among Holocaust survivors. Psychosom Med. 1989 Sep-Oct;51(5):577-89. doi: 10.1097/00006842-198909000-00009.

  PMID: 2798704 BACKGROUND

• Steer RA, Cavalieri TA, Leonard DM, Beck AT. Use of the Beck Depression Inventory for Primary Care to screen for major depression disorders. Gen Hosp Psychiatry. 1999 Mar-Apr;21(2):106-11. doi: 10.1016/s0163-8343(98)00070-x.

  PMID: 10228890 BACKGROUND

• Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.

  PMID: 444788 BACKGROUND

• Stub T, Irgens AC, Hansen AH, Knudsen-Baas O, Gaskjenn C, Kristoffersen AE. Impact of spiritual healing on moderate depression in adults: a study protocol of a pilot randomised controlled trial (RCT). BMJ Open. 2022 Sep 15;12(9):e062683. doi: 10.1136/bmjopen-2022-062683.

  PMID: 36109024 DERIVED

Related Links

• Medikamentfri behandling for psykiske syke i alle helseregioner
• Depression
• The use of complementary and alternative medicine (CAM) in Norway, 2018
• Diagnostic and Statistical Manual of Mental Disorders (DSM-5) American Psychiatric Association
• Notice of suspected adverse reaction when using medicines (including herbal medicines)

MeSH Terms

Interventions

Spiritual Therapies; Touch; Therapeutic Touch

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies

Central Study Contacts

Agnete E Kristoffersen, PhD

CONTACT

+47 7764 6147; agnete.kristoffersen@uit.no

Trine Stub, PhD

CONTACT

+4777649286; trine.stub@uit.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)