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Completed

NCT Number: NCT00322777

Spirituality Teaching Program for Depressed Adults

Major depression is a widely spread health problem in Canada. Recent research suggests a potential role for religion/spirituality in the prevention of and recovery from depression in adults. The purpose this study was to assess the efficacy of a home-based Spirituality Teaching Program for adults in the treatment of major depression. The objectives of the study were to determine:

1. whether the Spirituality Teaching Program is efficacious in improving depression severity, response rate, and remission rate in adults, 2. whether efficacy is maintained long term (over a 16 week period).

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canadian Institute of Natural and Integrative Medicine

Calgary, Alberta, T2N 1B9, Canada

About this study

Major depression is a widely spread health problem in Canada with a life time prevalence of 11% in men and 16% in women. A recent avenue of research suggests a role for religion/spirituality in the prevention of and recovery from depression. It has been hypothesized that religion/spirituality acts as a coping resource in distressing life situations including illness and loss and may address the struggles of depressed patients of feeling separated from their surrounding world, as well as from their inner self. Majority of the research conducted to date on this topic has been observational and focused on the religious denomination, primarily the Christian and Muslim faiths. However, given the distinction between spirituality and religion and since a growing portion of the Canadian population identifies themselves as nonreligious but spiritual (10), it is pertinent to explore whether there is a role for a nondenominational spiritual intervention as a mental health resource. Considering the burden of depression on an individual and social level and need for effective and accessible treatment options, evaluation of spirituality based approaches is highly relevant. This study aims to assess whether nurturing spiritual coping resources in a non-faith based way may play a therapeutic role in recovery from major depression in adults.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Satisfy the DSM-IV criteria for unipolar major depression with a depression score of 18-22 on the Hamilton Depression Scale (mild to moderate severity),
  • Are at least 18 years of age,
  • Have the competence to understand the study requirements and the ability to comply with the study intervention,
  • Have provided written informed consent.

Exclusion criteria

  • History of treatment resistance to two or more antidepressants when treated for an adequate period with a therapeutic dose
  • History of bipolar d/o, psychotic d/o, any psychotic episodes, personality d/o (except obsessive compulsive d/o)
  • History of multiple suicide attempts
  • Acute psychiatric condition other than unipolar depression
  • Regular use of medications (other than antidepressant, if applicable) that have mood altering effects, such as narcotics, anticonvulsants, illicit drugs or sleeping pills
  • Uncontrolled medical conditions in the last 3 months
  • DSM-IV diagnosis of substance abuse (except nicotine and caffeine) within the past 12-months
  • High suicide risk

Treatment and study plan

Spirituality Teaching Program

Behavioral

The Spirituality Teaching Program is a home study program delivered through audio CDs over an 8-week period. The program consists of weekly 90 minute teaching sessions, based on the content of a workshop developed to assist users in developing a more spiritual outlook on life and coping resources. Using didactic comment and storytelling, the following spiritual concepts are addressed in the sessions: self-transcendence, connectedness, forgiveness, self-acceptance, detachment, compassion and gratitude. Each session concludes with a relevant guided visualization practice. In addition, a 15-minute progressive relaxation exercise is included that is to be used on a daily basis. The presented content is nondenominational to ensure compatibility with any beliefs participants may hold.

Primary outcomes

  1. Hamilton Depression Rating Scale - Depression Severity

    Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks

    Depression severity was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). The HAM-D is a standardized outcome measure of depression severity in adults. Total scores includes the sum of 17-items, with eight items scored on a range of 0 (absent) to 2 (marked or definite) and nine scored on a range of 0 (absent) to 4 (very severe). The level of depression was based on the following scoring ranges: 7 or under not depressed, 8-13 some depressive symptoms but no depressive disorder, 12-15 mild depression, 16-19 moderate depression, 20-24 moderately severe depression, and 25+ severe depression.

    The HAM-D was administered through a face to face interview, which was conducted by a trained nurse who was blinded to participants' allocation.

Secondary outcomes

  1. Response Rate

    Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks

    Response rate was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). A response was determined as a reduction in the HAM-D score by at least 50% from the baseline score. The data are presented as the percentage of participants with response at each time point as compared to baseline.

  2. Remission

    Time frame: baseline, 8 weeks, 16 weeks, and 24 weeks

    Remission of depression was assessed at the four time points (baseline, 8 weeks, 16 weeks and 24 weeks) using the Hamilton Depression Rating Scale (HAM-D). Remission was based on a HAM-D score of less than 7. Remission is indicated as a percentage of participants at each time point whose scores were below 7.

Sponsors and collaborators

Lead sponsor

Canadian Institute of Natural and Integrative Medicine

Other

Collaborators

  • Alberta Health services
  • Arizona School of Health Sciences
  • Southwest Behavioral Health Sciences
  • The Center for Mind-Body Medicine
  • University of Calgary, Dept. of Psychiatry & Dept. of Community Health Sciences

Registry information

Official study title

A Spirituality Teaching Program for Depression in Adults: A Randomized Controlled Trial

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
May 8, 2006
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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