Efficacy of Psychotherapy Clinical Trial
Official title:
Efficacy of Eye Movement Desensitization & Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Depressive Disorders: Study Protocol for a Randomized Controlled Trial
| Verified date | February 2023 |
| Source | Khushal Khan Khattak Univeristy, Karak, Pakistan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Post-Traumatic Stress Disorder(PTSD) develops after exposure to or witnessing traumatic events. PTSD is highly comorbid and individuals with PTSD usually report Major Depressive Disorder(MDD). Common treatment choices for PTSD and MDD are either EMDR or CBT, however, little is known about their comparative efficacy, especially in Pakistan. Therefore, this Randomized Controlled Trial(RCT) aims at determining the comparative efficacy of EMDR vs CBT in Pakistan. This study will also examine the association between reduction in symptoms of PTSD and MDD over course of treatment. In this regard, two arms Crossover Randomized Controlled Trial(RCT) with Repeated Measures Design will be selected. This study will be conducted at two rehabilitation centres and patients will be screened at Time:01, baseline; Time:02, during treatment; Time:03, post treatment and Time:04, 06 months follow-up. All analyses will be performed according to intention-to-treat principle. Variations in symptoms will be analysed by using descriptive statistics, χ2 tests, t-tests, and one way ANOVA. To examine changes in PTSD and MDD across time and to check efficacy of each treatment, a series of Linear Mixed Models will be run. Furthermore, a series of multi-level lagged mediation analysis will be performed to check bi-directional mediation between changes PTSD and MDD over time. This protocol has outlined the rationale for determining efficacy of EMDR and CBT in Pakistan. It will help in answering a broad range of questions concerning efficacy of newly developed evidence-based treatments. Moreover, it may also guide future research on the treatment of PTSD and MDD in the developing countries.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | October 1, 2021 |
| Est. primary completion date | August 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | Exclusion Criteria: The following patients will be excluded: 1. Patients below the age of 18 years and above 60 years as this study is not on children or older patients; 2. Patients who can't move their hands and eyes/or can't perform basic movements; 3. Patients who are unconscious for longer periods and unable to recover consciousness; 4. Patients not meeting the basic screening criteria of PTSD/ PTSD is not the main problem; 5. Patients with severe intellectual impairments, since such patients are difficult to communicate. |
| Country | Name | City | State |
|---|---|---|---|
| Pakistan | Anwar Khan | Karak | KPK |
| Lead Sponsor | Collaborator |
|---|---|
| Khushal Khan Khattak Univeristy, Karak, Pakistan |
Pakistan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measurement of Change in the symptoms of Post Traumatic Stress Disorder | Clinician-Administered Post Traumatic Stress Disorder Scale-5 (Weathers, Blake, et al., 2013) These diagnostic tools will be used to assess the symptoms of Post Traumatic Stress Disorder. Any changes in the level of PTSD will be noted with respect to Pre, Mid and Post treatment stages The total symptom severity score is calculated by summing severity scores for the 20 Criterion A (items 1-5); (Exposure to actual or threatened death) Criterion B (items 6-7); (Presence of intrusion symptoms associated with the traumatic events) Criterion C (items 8-14); (Persistent avoidance of stimuli associated with the traumatic events) Criterion D (items 15-20). (Negative alterations in cognitions and mood associated with the traumatic events) Severity Rating 0. Absent: Mild / subthreshold:. Moderate / threshold: Severe / markedly elevated: Extreme / incapacitating: |
1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4). | |
| Primary | Measurement of Socio Demographic Profile | Socio-demographic characteristics of the patients, like age, gender, marital status, occupation and social background | 1st week at start of treatment, i.e, from date of randomization | |
| Secondary | Measurement of Change in the symptoms of major depression | Beck Depression Inventory-II (Steer, Ball, Ranieri, & Beck, 1999; Beck, Ward, Mendelson, Mock, & Erbaugh, 1961) This Inventory will be used to assess the symptoms of Major Depressive Disorder. Any changes in the level of Major Depression will be noted with respect to Pre, Mid and Post treatment stages Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the Beck Depression Inventory-II. There is a four-point scale for each item ranging from 0 to 3. On two items (16 and 18) there are seven options to indicate either an increase or decrease of appetite and sleep. Cut-off score guidelines for the BDI-II are given with the recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the Beck Depression Inventory-II. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe | 1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4). |