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CompletedNCT03299127Updated Jun 13, 2018

Imagery Rescripting in Depression

An interventional study of imagery rescripting in Depression, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-13.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Acute suicidality
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • 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)

    Behavioral: imagery rescripting

  • No intervention
    wait-list control

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

Interventions

  • Behavioralimagery rescripting

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change in BDI-II from pre- to post-intervention (i.e. 6 week interval)

Secondary outcomes

  1. 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.

    Time frame: Change from pre- to post-intervention (i.e. 6 week interval)

  2. Rosenberg Self-Esteem Scale (RSE)

    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)

  3. 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.

    Time frame: Change from pre- to post-intervention (i.e. 6 week interval)

  4. 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.

    Time frame: Change from pre- to post-intervention (i.e. 6 week interval)

06

Study locations

1 site
  • University Medical Center Hamburg Eppendorf
    Hamburg, 20246, Germany
07

References and documents

Publications

  • 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. PubMed 29597112 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03299127
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Oct 2, 2017
Start date
Apr 1, 2017
Primary completion
Jul 30, 2017
Completion
Dec 15, 2017
Last update
Jun 13, 2018

Study contacts

Steffen Moritz, PhD
principal investigator · UKE Hamburg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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