Efficacy of EMDR in the Treatment of Depression and Comorbid Anxiety

NCT04976413 | Unknown

• 1 other identifier: IRB: F.No. D-107-1(03)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depression; Anxiety

Keywords

EMDR; depression; anxiety; RCT

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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,

• 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,

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental arm will receive eight phase EMDR treatment using standard protocol. Selection of targets for reprocessing through EMDR will be made according to adaptive information processing model's postulations, that links traumatic events with the symptoms of depression and anxiety. Time period allocated to EMDR treatment is 12 -14 weeks . Follow up will be conducted after 12 weeks of treatment completion.

Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) psychotherapy

Control

ACTIVE COMPARATOR

Control group will receive treatment as usual (supportive counselling) for 12 -14 weeks

Behavioral: Counselling as usual

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) psychotherapy BEHAVIORAL

Experimental arm will receive eight phase EMDR treatment using manualized standard protocol. Selection of targets for reprocessing through EMDR will be made according to adaptive information processing model's postulations, that links traumatic events with the symptoms of depression and anxiety. Time period allocated to EMDR treatment is 12-14 weeks.

Also known as: EMDR

Experimental

Counselling as usual BEHAVIORAL

Control arm will receive counseling as usual for 12-14 weeks

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• item Clinically Useful Depression Outcome Scale (CUDOS) scores of 20 or more;
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Quaid-e-Azam University: lead

Study Sites (2)

Growing Edge Consultants

Islamabad, Federal Territory, 44000, Pakistan

RECRUITING

National Institute of Psychology, Center of Excellence, Quaid i Azam University, Islamabad, Pakistan.

Islamabad, Federal Territory, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Eye Movement Desensitization Reprocessing; Psychotherapy; Counseling

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Behavioral Disciplines and Activities; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yasmeen W Mauna Gauhar, M.Phil

  National Institute of Psychology, Quaid i Azam University Islamabad Pakistan

  PRINCIPAL INVESTIGATOR

• Dr. Humaira Jami, Ph.D

  National Institute of Psychology, Quaid i Azam University Islamabad Pakistan

  STUDY CHAIR

• Dr Derek Ferrel, Ph.D

  University of Worcester. U.K.

  STUDY CHAIR

• Dr Wajid Malik, MBBS FCPS

  Armed Forces Institute of Mental Health, Rawalpindi Pakistan

  STUDY DIRECTOR

Central Study Contacts

Yasmeen W Mauna Gauhar, M.Phil

CONTACT

+92 312 5115868; maunagauhar@hotmail.com;yasmeen_16@nip.edu.pk

Dr. Humaira Jami, Ph.D

CONTACT

+92 3335391580; jami@nip.edu.pk;jami.nip@qau.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessment and assignment to experimental and control conditions will be carried out by an independent evaluator who will be blind to the research hypotheses; treatment providers will be blind to the scores of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Control Clinical Trial

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 26, 2021
• Study Start: February 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: August 31, 2022
• Last Updated: May 19, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)