The effect of prayer therapy on depression and anxiety
| ISRCTN | ISRCTN03186168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03186168 |
| Secondary identifying numbers | H-31607-W01 |
- Submission date
- 14/09/2013
- Registration date
- 14/11/2013
- Last edited
- 14/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
It is well known that people who have experienced adversity in life are more prone to develop depression and anxiety. Through a research study it became evident that through prayer clients with this adversity experienced a release from the negative emotions and a related decrease in pondering of the hurtful events enabling them to move towards steady mental health more readily. This study aims to document the neural correlates of what is transpiring as the above occurs.
Who can participate?
Adults who are depressed but not on medication and are willing to engage in Christian prayer can participate in the study.
What does the study involve?
Participants are randomly allocated to one of two groups: the intervention group or the wait-list control group. People in the intervention group receive initial evaluation and prayer. Each prayer session lasts for about an hour and is conducted once a week for 6 weeks. Magnetic Resonance Imaging is done at the start and end of the study to record any changes happening in the brain. The wait-list control group will receive all the prayer sessions and evaluations as the interventions group but after 4 weeks.
What are the possible benefits and risks of participating?
This research does not involve major risks. Some clients may be disappointed in the prayer results while others may be encouraged.
Where is the study run from?
Baylor College of Medicine, Houston, Texas, USA.
When is the study starting and how long is it expected to run for?
The study starts in October 2013 and runs until April 2014.
Who is funding the study?
The Institute for Spirituality and Health, USA.
Who is the main contact?
Dr Peter Boelens
boelens3554@gmail.com
Contact information
Scientific
213 Redbud Dr
Vicksburg
39180
United States of America
| Phone | +1 601 299 1461 |
|---|---|
| boelens3554@gmail.com |
Study information
| Study design | Randomized wait-listed control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Neural correlates of the effect of prayer therapy on depression and anxiety |
| Study objectives | It is postulated that though prayer a decathexis of emotions from memory enabled patients to change abnormal thought patterns based on these negative emotions more readily. They were no longer bothered by flashbacks. As a result, individuals move from depression to normality. Further reading: Boelens PA, Reeves RR, Replogle WH, Koenig HG, A Randomized Trial of the Effect of Prayer on Depression and Anxiety. International Journal of Psychiatry in Medicine 2009;39(4):377-392 Boelens PA, Reeves RR, Replogle WH, Koenig HG, The Effect of Prayer on Depression and Anxiety: Maintenance of Positive Influence One Year After Prayer Intervention. International Journal of Psychiatry in Medicine 2012; 43(1):85-98. |
| Ethics approval(s) | Baylor College of Medicine Institutional Review Board, 23/08/2013 |
| Health condition(s) or problem(s) studied | Emotional disorders |
| Intervention | Group A receiving immediate evaluation and Christian prayer Group B wait-listed prior to following the same protocol as Group A Baseline rating scales and fMRI are performed immediately on entrance into the study. Subjects are then randomized into Group A or B. Group A goes into prayer intervention. Immediately at the conclusion of the prayer sessions both groups are re-evaluated even though Group B had no prayers. Group B is re-evaluated again prior to commencement of their prayers and at the conclusion of their prayers. Wait-list controls will receive their prayers within 4 weeks of the conclusion of prayers in the intervention group. Prayer sessions are 60 minutes in duration and conducted once a week for a duration of 6 weeks. |
| Intervention type | Other |
| Primary outcome measure | Brain changes resulting from prayer as documented through fMRI |
| Secondary outcome measures | 1. Clients that meet the requirements of the study are measured for the severity of their depression utilizing the Hamilton Depression Rating Scale (HDRS) with 17 items. Potential subjects who are not on antidepressant or antianxiety medication and have a minimal score of 8 on the HDRS will qualify for the study. The Hamilton Anxiety Rating Scales (HARS) with 14 symptom-related questions will be used to test anxiety. 2. The Life Orienting Test (LOT) will be used to measure the effects of dispositional optimism on self-regulation in a variety of circumstances. It has shown construct validity with other studies demonstrating the effect of optimism health promotion in a variety of circumstances. 3. The Daily Spiritual Experience Scale (DSES) will use 16 questions to assess daily spiritual experiences in six domains |
| Overall study start date | 07/10/2013 |
| Completion date | 06/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key inclusion criteria | 1. The subjects will be adults (male and female) between the ages of 18 and 65 who are depressed but not on medication 2. They will be willing to engage in Christian prayer and be without reservations or contraindications to fMRI scanning |
| Key exclusion criteria | 1. All children, pregnant women, mentally impaired and those with physically incapacitating problems will be excluded 2. Individuals with other psychiatric disorders and those who have received professional psychotherapy or have been on antidepressants in the 3 months prior to study enrollment. Subjects with severe depression and/or suicidal ideation will be excluded and proper referral made. 3. Those who are unable to respond to the questions or would have difficulty maintaining a focus while responding to the questions during the scanning would also be excluded. Subjects will be allowed to engage in their usual private prayers, devotions and church-related activities. They will not be allowed to participate in any form of psychotherapy during the time period they are in prayer session or are wait-listed. This restraint is lifted for the time period between the completion of their prayers and the one-year follow-up. 4. Additionally, subjects who are unable to understand and follow the directions involved in the testing will be excluded For the fMRI portion of this protocol, other exclusion criteria are: 1. Claustrophobia (this would make lying in the scanner very uncomfortable) 2. Pregnant 3. Contraindications to MRI: pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other piercings and implants |
| Date of first enrolment | 07/10/2013 |
| Date of final enrolment | 06/04/2014 |
Locations
Countries of recruitment
- United States of America
Study participating centre
39180
United States of America
Sponsor information
Research organisation
8100 Greenbriar #220
Houston
77054
United States of America
| Phone | +1 713 797 0600 |
|---|---|
| info@ish-tmc.org | |
| Website | http://Institute for Spirituality and Health |
"ROR" |
https://ror.org/00dqsbj20 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
