- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03299127
Imagery Rescripting in Depression
A Self-help Manual of Imagery Rescripting Reduces Depressive Symptoms
Study Overview
Detailed Description
Depression is among the world's leading causes of disability. Effective pharmacological and psychotherapeutic treatments exist. However, only a subgroup of individuals with depressive symptoms receive proper treatment (Kohn, Saxena, Levav, & Saraceno, 2004). To fill the existing treatment gap (Kazdin, 2017), psychological online interventions (POIs) and Internet-based treatment, including bibliotherapy with PDF manuals (POIs), are increasingly recommended as they are easily accessible and deemed an initial alternative approach (i.e., "foot in the door") for persons who have reservations about face-to-face psychotherapy. E-mental health and bilbiotherapeutic interventions have yielded promising results, but there remains room for improvement as effect sizes are usually in the small to medium range. The present trial aims to evaluate imagery rescripting, a technique developed by Smucker (Smucker, Dancu, Foa, & Niederee, 1995). With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". Positive mental imagery strategies seek to hold negative mental images in check and impart the patient with a feeling of self-efficacy. A new meta-analysis shows that imagery rescripting yields large effects on anxiety and depressive symptoms across a range of disorders (Morina, Lancee, & Arntz, 2017).
To the best of our knowledge, imagery rescripting has never been tested as a self-help intervention. A large sample of patients with primary or secondary depression (N = 120) will be recruited and randomly allocated to either the intervention group or a wait-list control group. The intervention group consists of two subgroups that will receive either a full or brief version of a manual teaching them imagery rescripting. Participants will be assessed at baseline and six weeks later. At post-assessment, the (full-length) manual will be made available to all participants. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II. Secondary outcome measures include self-reported symptom measures (PHQ-9, GAF-7, Rosenberg Self-Esteem Scale, Global item from the WHOQOL-BREF). The project may help to answer the question of whether imagery rescripting is effective when presented using a self-help medium.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hamburg, Germany, 20246
- University Medical Center Hamburg Eppendorf
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Electronic informed consent
- Internet access
- Adequate command of the German language
- Diagnosis of depression (primary or secondary)
Exclusion Criteria:
- Acute suicidality
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: imagery rescripting
bibliotherapy, intervention is provided by pdf-manual (either short or long version, i.e. 2 active arms, each 1/3 of sample receives either short or long version)
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The long version of the manual contained 4,959 words, the brief version had 3,369 words.
Individuals were encouraged patients to time travel to negative personal events, enter the scene and protect or comfort their younger-ego.
The participant should bring the negative event to a "happy end.
This could also be a fictive, compassionate person and may violate the laws of physics (e.g., a person may fly).
Readers were encouraged to embellish the scenes as much as possible so that it competed with the original scene.
This technique was then applied to future events.
For the last technique, patients were asked to seek a corresponding mood-congruent metaphor, creature or symbol; for example, a small bird that has fallen out of its nest.
Using their mind's eye, these images may be transformed into something of beauty or pride.
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No Intervention: wait-list control
wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Beck Depression Inventory II
Time Frame: Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)
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Beck Depression Inventory II (BDI II) (Beck, Steer, & Brown, 1996).
The BDI-II is a self-report scale that contains 21 Items that tap into cognitive, behavioral and somatic symptoms of depression.
A follow-up assessment after six month serves as secondary outcome.
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Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Health Questionnaire (PHQ-9)
Time Frame: Change from pre- to post-intervention (i.e. 6 week interval)
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The Patient Health Questionnaire (PHQ-9) is a self-administered scale derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) and measures depression according to the nine depression items of the DSM-IV.
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Change from pre- to post-intervention (i.e. 6 week interval)
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Rosenberg Self-Esteem Scale (RSE)
Time Frame: Change from pre- to post-intervention (i.e. 6 week interval)
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The Rosenberg Self-Esteem Scale (RSE) assesses self-esteem with 10 items.
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Change from pre- to post-intervention (i.e. 6 week interval)
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Generalized Anxiety Disorders 7 (GAD-7)
Time Frame: Change from pre- to post-intervention (i.e. 6 week interval)
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The Generalized Anxiety Disorders 7 (GAD-7) is a screening instrument for common anxiety symptoms consisting of seven items.
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Change from pre- to post-intervention (i.e. 6 week interval)
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Global item of the WHO Quality of Life scale (WHOQOL-BREF)
Time Frame: Change from pre- to post-intervention (i.e. 6 week interval)
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The global item of the WHO Quality of Life scale (WHOQOL-BREF) assesses quality of Life.
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Change from pre- to post-intervention (i.e. 6 week interval)
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Collaborators and Investigators
Investigators
- Principal Investigator: Steffen Moritz, PhD, UKE Hamburg
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR-Phoenix
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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