Depression Clinical Trial
Official title:
Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Psychotherapy in the Treatment of Depression and Comorbid Anxiety: A Randomized Control Trial
This research is aimed at investigating the efficacy of eye movement desensitization and reprocessing (EMDR) psychotherapy for treating depression and comorbid anxiety symptoms. EMDR has been scientifically established as an evidenced based level-A treatment for PTSD. However, researchers have started assessing its efficacy for depression and other psychological disorders. Preliminary evidence indicates that EMDR has the potential to treat depression, however, it has not yet been established as an evidence-based intervention. Anxiety most often comorbid with depression. literature suggests that when depression is treated, the comorbid anxiety symptoms are also reduced. Hence, the effect of EMDR therapy on anxiety symptoms, when treating depressive symptoms would also be explored. A sample of 40 volunteers will be sought from community through advertising, and through referrals and will be randomly assigned to experimental and control conditions. Participants of experimental condition will be offered eight phase EMDR therapy in a period of 12-14 weeks. Participants of control group will receive counselling as usual sessions for 12-14 weeks. Measurement of the depression and anxiety symptoms for Experimental group will be recorded at Time 1, (baseline, time frame: 0 week). Time 2 (after history and preparation for EMDR, time frame: 3 weeks). Time 3, (after EMDR treatment, time frame: 12 weeks) and at T4, ( post treatment follow-up, Time frame: 24 weeks. For Control group, measurements will be recorded at T1, T2 and T3. The current study will be the first registered Randomized Control Trial (RCT ) as per investigators knowledge, that will explore the efficacy of EMDR in treating depression and comorbid anxiety. The results of the study will provide the scientific bases to use EMDR as a treatment of choice for depression and anxiety. Many clients do not respond to pharmacological as well other psychological treatments despite bearing huge financial cost. EMDR therapy can be a short-term treatment that may provide relief from symptoms of depression and anxiety, and as a result, the functioning and quality of life of the participants will also improve. This study will also guide further research to explore the effects of EMDR on other trauma-based disorders and comorbid conditions.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - 18-item Clinically Useful Depression Outcome Scale (CUDOS) scores of 20 or more; - 20-item Clinically Useful Anxiety Outcome Scale (CUXOS) scores of 20 or more; - IES scores of less than or equal to 33 - DES scores of less than or equal to 36 - English or Urdu speaking - Ability to understand terms and willingness to participate in the study, give informed consent - Currently not taking any psychological or psychiatric treatment - No substance dependence (except tobacco smoking) Exclusion Criteria: - Brain injury/ organicity, neurological illnesses, high dissociation, PTSD - Schizophrenia/ psychotic disorders spectrum - Bipolar disorders - Substance dependence - Other disorders poorly suited to study treatments (e.g., personality disorders) - Serious suicidal ideation that requires immediate attention - Any psychiatric or medical condition impeding participation in the study - Current pregnancy |
Country | Name | City | State |
---|---|---|---|
Pakistan | Growing Edge Consultants | Islamabad | Federal Territory |
Pakistan | National Institute of Psychology, Center of Excellence, Quaid i Azam University, Islamabad, Pakistan. | Islamabad | Federal Territory |
Lead Sponsor | Collaborator |
---|---|
Quaid-e-Azam University |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DSM-5 Self-Rated Level 1 Cross Cutting Symptoms Measure Adult, English and Urdu versions | Measures cross cutting symptoms across psychiatric domains. Scores on each item ranges from 0-4. A score of 0 indicates no symptoms and 4 means worst outcome | Week 0, baseline | |
Primary | Clinically Useful Depression Outcome Scale, English and Urdu versions | Measures baseline and changes in depressive symptoms, functioning and quality of life, scores on each item ranges from 0-4. A score of 0 indicate no symptoms and 4 means worst outcome | week 0, week -3, week 12, week 24 | |
Primary | Clinically Useful Anxiety Outcome Scale, English and Urdu versions | Measures baseline and changes in anxiety symptoms, scores on each item ranges from 0-4. A score of 0 indicates no symptoms and 4 means worst outcome | week 0, week -3, week 12, week 24 | |
Primary | Dissociative Experience Scale-II, English and Urdu versions | Measures dissociative symptoms scores on each item ranges from 0%-100%. A score of 0% indicates no symptoms and 100% means worst outcome | Week 0, | |
Primary | Impact of Event scale, English and Urdu versions | Measures event-specific distress, scores on each item ranges from 0-4. A score of 0 indicates no symptoms and 4 means worst outcome | Week 0, |
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