Effectiveness of adjuvant Positive Psychotherapy on illness severity and wellbeing in Escitalopram non-responder patients with moderate to severe Depression: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Illness Severity of Depression using PHQ-9 score. A score less than 10 will show change in illness severity
研究概览
简要总结
**Need for the study:**Many studies have shown the effectiveness of Positive Psychotherapy on depression.Positive psychotherapy reduces depressive symptoms and improves wellbeing at a rate that is comparable to or better than traditional psychotherapy. However, in India, studies using Positive Psychotherapy/ Positive Psychology interventions is in its infancy and we could not find any study been done on clinical population in the country. To the best of our knowledge we could also not find literature on its effectiveness on first line treatment non-responders specifically. Thus, the current study is to examine the effectiveness of Positive Psychotherapy augmentation on escitalopram treatment non responders of depression.
Statement of the problem: The present study aims to see the effectiveness of adjuvant Positive Psychotherapy on the severity of depression and psychological well-being in escitalopram non responders, patients with moderate to severe depression.
Hypotheses:
-
There is no significant difference between intervention group and TAU in the reduction of depressive symptoms among escitalopram non responders of moderate to severe depression.
-
There is no significant difference between intervention group and TAU in ameliorating psychological wellbeing among escitalopram non responders of moderate to severe depression
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Provision of signed and dated informed consent form
- •Clients diagnosed according to ICD-11 criteria for : · 6A70.1 Single Episode Depressive Disorder, Moderate, without psychotic symptoms · 6A70.3 Single Episode Depressive Disorder, Severe, without psychotic symptoms · A71.1 Recurrent Depressive Disorder, Current Episode Moderate, without psychotic symptoms · 6A71.3 Recurrent Depressive Disorder, Current Episode Severe, without psychotic symptoms
- •Age 18 to 50 years
- •Attend AIIMS Bhopal Psychiatry OPD
- •A score of 10 or above on the Patient Health Questionnaire 9 (PHQ-9)
- •Educated at least till 10th standard
- •Participants who are non responders of escitalopram.
排除标准
- •1.Women who are pregnant or are breastfeeding or lactating
- •Participants with a history of organicity, epilepsy, or other neurological deficits.
- •Participants with a history of intellectual disability, psychosis, including schizophrenia spectrum disorders or bipolar disorder.
- •Participants planning to move out of the study area during the follow-up period.
- •Participants who do not speak either English or Hindi.
- •Participants who are undergoing psychotherapy for depression at the time of recruitment.
- •Participants at imminent risk for suicide.
- •Participants who have documented non-response to fluoxetine in current or past episodes.
结局指标
主要结局
Illness Severity of Depression using PHQ-9 score. A score less than 10 will show change in illness severity
时间窗: Baseline, 4 weeks, 10 weeks, 1 month post intervention
次要结局
- Improvement in Wellbeing using Mental Health Continuum score(Baseline, 10 weeks)
研究者
Michelle Melwyn Joel
AIIMS Bhopal