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Imagery Rescripting in Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
imagery rescripting
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Electronic informed consent
  • Internet access
  • Adequate command of the German language
  • Diagnosis of depression (primary or secondary)

Exclusion Criteria:

  • Acute suicidality

Sites / Locations

  • University Medical Center Hamburg Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

imagery rescripting

wait-list control

Arm Description

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)

wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample)

Outcomes

Primary Outcome Measures

Beck Depression Inventory II
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.

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)
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.
Rosenberg Self-Esteem Scale (RSE)
The Rosenberg Self-Esteem Scale (RSE) assesses self-esteem with 10 items.
Generalized Anxiety Disorders 7 (GAD-7)
The Generalized Anxiety Disorders 7 (GAD-7) is a screening instrument for common anxiety symptoms consisting of seven items.
Global item of the WHO Quality of Life scale (WHOQOL-BREF)
The global item of the WHO Quality of Life scale (WHOQOL-BREF) assesses quality of Life.

Full Information

First Posted
September 27, 2017
Last Updated
June 11, 2018
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT03299127
Brief Title
Imagery Rescripting in Depression
Official Title
A Self-help Manual of Imagery Rescripting Reduces Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Depression is among the world's leading causes of disability. To fill the existing treatment gap, 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. The present trial aims to evaluate imagery rescripting. With the help of various techniques, the approach aims to edit negative memories and rewrite a "happy end". 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. A follow-up assessment will be completed six months later. The primary outcome measure is the Beck Depression Inventory II.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized-controlled trial, wait-list control condition
Masking
None (Open Label)
Masking Description
self-report serves as outcomes, patients are not masked
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
imagery rescripting
Arm Type
Experimental
Arm Description
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)
Arm Title
wait-list control
Arm Type
No Intervention
Arm Description
wait-list control, participants receive intervention manual upon completion of post-assessment (1/3 of sample)
Intervention Type
Behavioral
Intervention Name(s)
imagery rescripting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Depression Inventory II
Description
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.
Time Frame
Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Change from pre- to post-intervention (i.e. 6 week interval)
Title
Rosenberg Self-Esteem Scale (RSE)
Description
The Rosenberg Self-Esteem Scale (RSE) assesses self-esteem with 10 items.
Time Frame
Change from pre- to post-intervention (i.e. 6 week interval)
Title
Generalized Anxiety Disorders 7 (GAD-7)
Description
The Generalized Anxiety Disorders 7 (GAD-7) is a screening instrument for common anxiety symptoms consisting of seven items.
Time Frame
Change from pre- to post-intervention (i.e. 6 week interval)
Title
Global item of the WHO Quality of Life scale (WHOQOL-BREF)
Description
The global item of the WHO Quality of Life scale (WHOQOL-BREF) assesses quality of Life.
Time Frame
Change from pre- to post-intervention (i.e. 6 week interval)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Electronic informed consent Internet access Adequate command of the German language Diagnosis of depression (primary or secondary) Exclusion Criteria: Acute suicidality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Moritz, PhD
Organizational Affiliation
UKE Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29597112
Citation
Moritz S, Ahlf-Schumacher J, Hottenrott B, Peter U, Franck S, Schnell T, Peter H, Schneider BC, Jelinek L. We cannot change the past, but we can change its meaning. A randomized controlled trial on the effects of self-help imagery rescripting on depression. Behav Res Ther. 2018 May;104:74-83. doi: 10.1016/j.brat.2018.02.007. Epub 2018 Feb 26.
Results Reference
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Imagery Rescripting in Depression

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